Spinal Cord Injury
Conditions
Keywords
spinal cord injury, neural control, motor function, hand movement
Brief summary
The goals of this study are to examine the physiology of Central Nervous System pathways contributing to the control of upper and lower extremity movements after SCI, and to promote the recovery of extremity movements by using non-invasive brain stimulation and motor training.
Detailed description
This study will consist of electromyography (surface and intramuscular), peripheral nerve stimulation, and transcranial magnetic stimulation, electrical stimulation, of the hand, arm, leg, and foot representation of the primary motor cortex, as well as MRI scans of the brain. The investigators will examine the physiological measurements of upper and lower extremity muscles (such as in the first dorsal interosseous (FDI), biceps brachii (BIC), anterior deltoid (AD), tibialis anterior (TA), hamstring (HAMS) and quadriceps (QUAD)). This study may occur at the Miami Project to cure Paralysis at the University of Miami. The investigators will include subjects between the ages of 18 and 85, both healthy controls and individuals with chronic spinal cord injuries that occurred at least 6 months prior to recruitment. Both healthy controls and those with spinal cord injuries will be able to perform small hand and arm movements and small leg and foot movements. The primary outcome measures of this study are muscle responses to stimulation with magnetic pulses using TMS and electrical stimulation of a peripheral nerve in the arm or leg. The investigators propose to enhance the recovery of motor function by using new protocols of high frequency non-invasive repetitive TMS (rTMS) and motor training. Repetitive TMS will be used during hand, arm, leg and foot movements in a task-dependent manner to induce cortical plasticity and enhance voluntary output of the muscles associated with those movements. Second, rTMS will be applied in a task-dependent manner during a visuo-motor training task that also involves movements of the hands, arms, legs or feet.
Interventions
DEVICErTMS
small magnetic pulses will be given to the brain in a non invasive manner.
DEVICESham rTMS
sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner
OTHERTraining
at the direction of the researcher the participant will be instructed to do repetitive motor movements with their arm, hand or leg. this is called training
OTHERMotor Task
participants will be asked to perform specific motor tasks or movements with their fingers, hands, arms or legs.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Male and female Veterans and non Veterans with spinal cord injury at least 6 months after injury was sustained. The investigators also plan to enroll control subjects who do not have any history of spinal cord injury. Participants who are unimpaired healthy controls: * Male and females between ages 18-85 years * Right handed * Able to complete precision grips with both hands * Able to complete full wrist flexion-extension bilaterally * Able to walk unassisted * Able to complete full ankle flexion-extension bilaterally Participants who have had a spinal cord injury: * Male and females between ages 18-85 years * Chronic SCI ( 6 months of injury) * Spinal Cord injury at or above L5 * The ability to produce a visible precision grip force with one hand * Individuals who have the ability to pick up a small object (large paperclip) from a table independently * Able to perform some small wrist flexion and extension (measured by a goniometer) * The ability to perform a small visible contraction with dorsiflexor and hip flexor muscles * No subjects will be excluded based on their race, religion, ethnicity, gender or HIV status.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Post rTMS, Sham rTMS, and Sham rTMS over control brain for all sessions at minute 0, 10, 30, and 60 | For Wrist flexion and precision grip + rTMS/Sham rTMS and Wrist extension and precision grip + rTMS/Sham rTMS we measured the changes in the MEPs before the intervention(rTMS/Sham rTMS) at minute 0, 10, 30, and 60 and then again after at minute 0, 10, 30, and 60. The information below is separated first by wrist flexion or extension, then by study visit (rTMS or Sham rTMS), and finally by subject characteristic (SCI or control). This study is a crossover design, what that means is subjects (SCI and Controls) will participate in both sessions (rTMS and Sham rTMS). For rTMS/Sham rTMS/Sham rTMS over control brain area we measured the changes in the MEPs at minute 0, 10, 30, and 60.The information for this arm is separated by study visit: Session 1 is rTMS, Session 2 is Sham rTMS, and Session 3 is Sham rTMS over control brain area. For Training + rTMS and Training + Sham rTMS we measured the changes in the MEPs at baseline, post 5 training sessions, and post all training sessions. |
| Electromyography (EMG) | Before and After the stimulation during each 2-hour session (rTMS/Sham rTMS/Sham rTMS over control brain area) | For rTMS/Sham rTMS/Sham rTMS over control brain area we measured voluntary output in hand muscles using EMG before and after the stimulation.The information for this arm is separated by study visit: Session 1 is rTMS, Session 2 is Sham rTMS, and Session 3 is Sham rTMS over control brain area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Jebsen Taylor Hand Function Test (JTT) | The JTT was measured at Baseline, Post 5 training sessions, and Post all training sessions at each 2-hour session. | The JTT is a standardized test of several major aspects of hand function using simulated activities of daily living (writing, picking up small objects, picking up heavy objects etc.). The time taken to perform simulated activities of daily living is assessed. Lesser time to perform the activities would be considered a better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wrist Flexion and Precision Grip + rTMS and Sham rTMS (SCI) This study arm is a crossover design. Participants will complete the following two randomized sessions: 1. Wrist flexion and precision grip + rTMS; 2. Wrist flexion and precision grip + Sham rTMS.
Participants will complete two study visits each lasting \
2 hours separated by at least two days.
In the Wrist flexion and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. Transcranial magnetic stimuli (TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.
Wrist flexion and precision grip + Sham rTMS:
The same procedures listed above will be completed before and after Sham rTMS. | 5 |
| Wrist Flexion and Precision Grip + rTMS and Sham rTMS (Controls) This study arm is a crossover design. Participants will complete the following two randomized sessions: 1. Wrist flexion and precision grip + rTMS; 2. Wrist flexion and precision grip + Sham rTMS.
Participants will complete two study visits each lasting \
2 hours separated by at least two days.
In the Wrist flexion and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. Transcranial magnetic stimuli (TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.
Wrist flexion and precision grip + Sham rTMS:
The same procedures listed above will be completed before and after Sham rTMS. | 5 |
| Wrist Extension and Precision Grip + rTMS and Sham rTMS (SCI) This study arm is a crossover design. Participants will complete the following two randomized sessions: 1. Wrist extension and precision grip + rTMS; 2. Wrist extension and precision grip + Sham rTMS.
Participants will complete two study visits each lasting \
2 hours separated by at least two days.
In the Wrist extension and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. Transcranial magnetic stimuli (TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.
Wrist extension and precision grip + Sham rTMS:
The same procedures listed above will be completed before and after Sham rTMS. | 5 |
| Wrist Extension and Precision Grip + rTMS and Sham rTMS (Controls) This study arm is a crossover design. Participants will complete the following two randomized sessions: 1. Wrist extension and precision grip + rTMS; 2. Wrist extension and precision grip + Sham rTMS.
Participants will complete two study visits each lasting \
2 hours separated by at least two days.
In the Wrist extension and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. Transcranial magnetic stimuli (TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60.
Wrist extension and precision grip + Sham rTMS:
The same procedures listed above will be completed before and after Sham rTMS. | 5 |
| rTMS/Sham rTMS/Sham rTMS Over Control Brain Area This study arm is a 3 way crossover design. Participants are randomized to one of the 3 study groups: rTMS, Sham rTMS, and Sham rTMS over control brain area. Participants will complete all study groups. Each study group consists of one study visit lasting \
2 hours and there is a 1 week washout period between each study visit.
rTMS stimulation: In this group, rTMS stimulation will be targeting finger and wrist muscles during precision grip. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. The maximum voluntary contraction (MVC) will be measured using surface EMG before rTMS and again after.
Sham or fake rTMS stimulation: In this group, Sham rTMS stimulation will be targeting finger and wrist muscles during precision grip. TMS measurements in the form of MEPs will be taken at minute 0, 10, 30, and 60. The MVC will be measured using surface EMG before rTMS and again after.
Sham rTMS over control brain area: In this group, Sham rTMS will be applies over the dorsolateral prefrontal cortex (DLPFC) or at the leg presentation of the primary motor cortex, or at other related control area. TMS measurements in the form of MEPs will be taken at minute 0, 10, 30, and 60. The MVC will be measured using surface EMG before rTMS and again after.
Participants are asked to wait a 1 week washout period between sessions. | 5 |
| Training + rTMS Participants will be asked to follow a target line on the computer as accurately as possible while performing precision grips or foot movement . Magnetic stimulation will be given during rest and movement.
rTMS: small magnetic pulses will be given to the brain in a non invasive manner.
Training: at the direction of the researcher the participant will be instructed to do repetitive motor movements with their arm, hand or leg. this is called training | 4 |
| Training + Sham rTMS Participants will be asked to follow a target line on the computer as accurately as possible while performing precision grips or foot movement . Magnetic stimulation will be given during rest and movement.
Sham rTMS: sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner
Training: at the direction of the researcher the participant will be instructed to do repetitive motor movements with their arm, hand or leg. this is called training | 3 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Some subjects were unable to commit to the training study. | 0 | 0 | 0 | 4 | 6 |
Baseline characteristics
| Characteristic | Wrist Flexion and Precision Grip + rTMS and Sham rTMS (Controls) | Wrist Extension and Precision Grip + rTMS and Sham rTMS (SCI) | Wrist Extension and Precision Grip + rTMS and Sham rTMS (Controls) | rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | Training + rTMS | Training + Sham rTMS | Wrist Flexion and Precision Grip + rTMS and Sham rTMS (SCI) | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 3 Participants | 5 Participants | 32 Participants |
| Age, Continuous | 48 years | 53 years | 51 years | 43 years | 45 years | 41 years | 44 years | 45 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 1 Participants | 4 Participants | 3 Participants | 2 Participants | 3 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants |
| Region of Enrollment United States | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 3 Participants | 5 Participants | 32 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 8 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 4 Participants | 4 Participants | 3 Participants | 3 Participants | 5 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 5 | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 5 | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 5 | 0 / 4 | 0 / 3 |
Outcome results
Primary
Electromyography (EMG)
For rTMS/Sham rTMS/Sham rTMS over control brain area we measured voluntary output in hand muscles using EMG before and after the stimulation.The information for this arm is separated by study visit: Session 1 is rTMS, Session 2 is Sham rTMS, and Session 3 is Sham rTMS over control brain area.
Time frame: Before and After the stimulation during each 2-hour session (rTMS/Sham rTMS/Sham rTMS over control brain area)
Population: The EMG measurement was not collected in every study arm, only this arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wrist Flexion and Precision Grip + rTMS (SCI) | Electromyography (EMG) | Session 1: Before | 0.138 Millivolts (mV) | Standard Deviation 0.239 |
| Wrist Flexion and Precision Grip + rTMS (SCI) | Electromyography (EMG) | Session 1: After | 0.191 Millivolts (mV) | Standard Deviation 0.323 |
| Wrist Flexion and Precision Grip + rTMS (SCI) | Electromyography (EMG) | Session 2: Before | 0.204 Millivolts (mV) | Standard Deviation 0.361 |
| Wrist Flexion and Precision Grip + rTMS (SCI) | Electromyography (EMG) | Session 2: After | 0.208 Millivolts (mV) | Standard Deviation 0.384 |
| Wrist Flexion and Precision Grip + rTMS (SCI) | Electromyography (EMG) | Session 3: Before | 0.221 Millivolts (mV) | Standard Deviation 0.329 |
| Wrist Flexion and Precision Grip + rTMS (SCI) | Electromyography (EMG) | Session 3: After | 0.231 Millivolts (mV) | Standard Deviation 0.352 |
Primary
Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS
For Wrist flexion and precision grip + rTMS/Sham rTMS and Wrist extension and precision grip + rTMS/Sham rTMS we measured the changes in the MEPs before the intervention(rTMS/Sham rTMS) at minute 0, 10, 30, and 60 and then again after at minute 0, 10, 30, and 60. The information below is separated first by wrist flexion or extension, then by study visit (rTMS or Sham rTMS), and finally by subject characteristic (SCI or control). This study is a crossover design, what that means is subjects (SCI and Controls) will participate in both sessions (rTMS and Sham rTMS). For rTMS/Sham rTMS/Sham rTMS over control brain area we measured the changes in the MEPs at minute 0, 10, 30, and 60.The information for this arm is separated by study visit: Session 1 is rTMS, Session 2 is Sham rTMS, and Session 3 is Sham rTMS over control brain area. For Training + rTMS and Training + Sham rTMS we measured the changes in the MEPs at baseline, post 5 training sessions, and post all training sessions.
Time frame: Post rTMS, Sham rTMS, and Sham rTMS over control brain for all sessions at minute 0, 10, 30, and 60
Population: The number differs due to different study visits in each arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wrist Flexion and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 60 | 0.55 millivolts (mV) | Standard Deviation 1.18 |
| Wrist Flexion and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 30 | 0.50 millivolts (mV) | Standard Deviation 1.44 |
| Wrist Flexion and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 30 | 0.36 millivolts (mV) | Standard Deviation 0.83 |
| Wrist Flexion and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 0 | 0.36 millivolts (mV) | Standard Deviation 1.03 |
| Wrist Flexion and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 10 | 0.33 millivolts (mV) | Standard Deviation 0.56 |
| Wrist Flexion and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 0 | 0.31 millivolts (mV) | Standard Deviation 0.52 |
| Wrist Flexion and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 60 | 0.39 millivolts (mV) | Standard Deviation 1.02 |
| Wrist Flexion and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 10 | 0.35 millivolts (mV) | Standard Deviation 0.83 |
| Wrist Flexion and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 30 | 0.41 millivolts (mV) | Standard Deviation 0.8 |
| Wrist Flexion and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 30 | 0.43 millivolts (mV) | Standard Deviation 0.61 |
| Wrist Flexion and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 10 | 0.44 millivolts (mV) | Standard Deviation 0.79 |
| Wrist Flexion and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 60 | 0.42 millivolts (mV) | Standard Deviation 0.65 |
| Wrist Flexion and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 0 | 0.43 millivolts (mV) | Standard Deviation 0.77 |
| Wrist Flexion and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 60 | 0.44 millivolts (mV) | Standard Deviation 0.71 |
| Wrist Flexion and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 10 | 0.39 millivolts (mV) | Standard Deviation 0.88 |
| Wrist Flexion and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 0 | 0.45 millivolts (mV) | Standard Deviation 0.81 |
| Wrist Flexion and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 10 | 0.47 millivolts (mV) | Standard Deviation 1.12 |
| Wrist Flexion and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 10 | 0.51 millivolts (mV) | Standard Deviation 0.35 |
| Wrist Flexion and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 60 | 0.55 millivolts (mV) | Standard Deviation 0.33 |
| Wrist Flexion and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 0 | 0.49 millivolts (mV) | Standard Deviation 1.26 |
| Wrist Flexion and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 30 | 0.51 millivolts (mV) | Standard Deviation 0.52 |
| Wrist Flexion and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 0 | 0.45 millivolts (mV) | Standard Deviation 0.81 |
| Wrist Flexion and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 30 | 0.50 millivolts (mV) | Standard Deviation 0.81 |
| Wrist Flexion and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 60 | 0.53 millivolts (mV) | Standard Deviation 0.85 |
| Wrist Flexion and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 30 | 0.68 millivolts (mV) | Standard Deviation 0.91 |
| Wrist Flexion and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 60 | 0.72 millivolts (mV) | Standard Deviation 1.15 |
| Wrist Flexion and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 10 | 0.71 millivolts (mV) | Standard Deviation 1.13 |
| Wrist Flexion and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 10 | 0.71 millivolts (mV) | Standard Deviation 1.08 |
| Wrist Flexion and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 30 | 0.73 millivolts (mV) | Standard Deviation 0.91 |
| Wrist Flexion and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 60 | 0.74 millivolts (mV) | Standard Deviation 0.78 |
| Wrist Flexion and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 0 | 0.66 millivolts (mV) | Standard Deviation 0.82 |
| Wrist Flexion and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 0 | 0.65 millivolts (mV) | Standard Deviation 1.12 |
| Wrist Extension and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 10 | 0.37 millivolts (mV) | Standard Deviation 0.83 |
| Wrist Extension and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 60 | 0.45 millivolts (mV) | Standard Deviation 0.98 |
| Wrist Extension and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 60 | 0.46 millivolts (mV) | Standard Deviation 0.88 |
| Wrist Extension and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 30 | 0.42 millivolts (mV) | Standard Deviation 1.17 |
| Wrist Extension and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 0 | 0.44 millivolts (mV) | Standard Deviation 0.67 |
| Wrist Extension and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 10 | 0.41 millivolts (mV) | Standard Deviation 1.02 |
| Wrist Extension and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 0 | 0.33 millivolts (mV) | Standard Deviation 0.92 |
| Wrist Extension and Precision Grip + rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 30 | 0.42 millivolts (mV) | Standard Deviation 0.91 |
| Wrist Extension and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 0 | 0.44 millivolts (mV) | Standard Deviation 0.61 |
| Wrist Extension and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 60 | 0.66 millivolts (mV) | Standard Deviation 0.98 |
| Wrist Extension and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 60 | 0.42 millivolts (mV) | Standard Deviation 1.02 |
| Wrist Extension and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 30 | 0.63 millivolts (mV) | Standard Deviation 1.12 |
| Wrist Extension and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 10 | 0.59 millivolts (mV) | Standard Deviation 1.03 |
| Wrist Extension and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 30 | 0.45 millivolts (mV) | Standard Deviation 0.93 |
| Wrist Extension and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 0 | 0.61 millivolts (mV) | Standard Deviation 0.98 |
| Wrist Extension and Precision Grip + Sham rTMS (SCI) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 10 | 0.46 millivolts (mV) | Standard Deviation 0.72 |
| Wrist Extension and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 10 | 0.66 millivolts (mV) | Standard Deviation 1.02 |
| Wrist Extension and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 0 | 0.66 millivolts (mV) | Standard Deviation 1.03 |
| Wrist Extension and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 30 | 0.63 millivolts (mV) | Standard Deviation 1.07 |
| Wrist Extension and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 60 | 0.65 millivolts (mV) | Standard Deviation 0.97 |
| Wrist Extension and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 0 | 0.59 millivolts (mV) | Standard Deviation 0.98 |
| Wrist Extension and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 10 | 0.71 millivolts (mV) | Standard Deviation 0.98 |
| Wrist Extension and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 30 | 0.72 millivolts (mV) | Standard Deviation 1.04 |
| Wrist Extension and Precision Grip + rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 60 | 0.74 millivolts (mV) | Standard Deviation 1.12 |
| Wrist Extension and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 10 | 0.63 millivolts (mV) | Standard Deviation 0.7 |
| Wrist Extension and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 0 | 0.52 millivolts (mV) | Standard Deviation 0.83 |
| Wrist Extension and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 60 | 0.61 millivolts (mV) | Standard Deviation 0.82 |
| Wrist Extension and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 30 | 0.53 millivolts (mV) | Standard Deviation 0.92 |
| Wrist Extension and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Before: minute 10 | 0.56 millivolts (mV) | Standard Deviation 1.06 |
| Wrist Extension and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 0 | 0.57 millivolts (mV) | Standard Deviation 0.91 |
| Wrist Extension and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 60 | 0.62 millivolts (mV) | Standard Deviation 0.87 |
| Wrist Extension and Precision Grip + Sham rTMS (Control) | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | After: minute 30 | 0.61 millivolts (mV) | Standard Deviation 1.02 |
| rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Session 1: minute 0 | 0.41 millivolts (mV) | Standard Deviation 0.52 |
| rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Session 1: minute 10 | 0.47 millivolts (mV) | Standard Deviation 0.91 |
| rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Session 1: minute 30 | 0.49 millivolts (mV) | Standard Deviation 0.82 |
| rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Session 1: minute 60 | 0.52 millivolts (mV) | Standard Deviation 0.7 |
| rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Session 2: minute 0 | 0.59 millivolts (mV) | Standard Deviation 0.98 |
| rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Session 2: minute 10 | 0.54 millivolts (mV) | Standard Deviation 0.77 |
| rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Session 2: minute 30 | 0.61 millivolts (mV) | Standard Deviation 1.03 |
| rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Session 2: minute 60 | 0.58 millivolts (mV) | Standard Deviation 0.95 |
| rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Session 3: minute 0 | 0.66 millivolts (mV) | Standard Deviation 1.02 |
| rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Session 3: minute 10 | 0.67 millivolts (mV) | Standard Deviation 0.98 |
| rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Session 3: minute 30 | 0.69 millivolts (mV) | Standard Deviation 1.28 |
| rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Session 3: minute 60 | 0.70 millivolts (mV) | Standard Deviation 1.02 |
| Training + rTMS | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Baseline | 0.61 millivolts (mV) | Standard Deviation 0.79 |
| Training + rTMS | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Post 5 training sessions | 0.70 millivolts (mV) | Standard Deviation 0.92 |
| Training + rTMS | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Post all training sessions | 0.80 millivolts (mV) | Standard Deviation 0.83 |
| Training + Sham rTMS | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Baseline | 0.61 millivolts (mV) | Standard Deviation 0.8 |
| Training + Sham rTMS | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Post 5 training sessions | 0.68 millivolts (mV) | Standard Deviation 0.74 |
| Training + Sham rTMS | Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS | Post all training sessions | 0.69 millivolts (mV) | Standard Deviation 0.88 |
Secondary
The Jebsen Taylor Hand Function Test (JTT)
The JTT is a standardized test of several major aspects of hand function using simulated activities of daily living (writing, picking up small objects, picking up heavy objects etc.). The time taken to perform simulated activities of daily living is assessed. Lesser time to perform the activities would be considered a better outcome.
Time frame: The JTT was measured at Baseline, Post 5 training sessions, and Post all training sessions at each 2-hour session.
Population: The JTT was not measured in all study arms, only this arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wrist Flexion and Precision Grip + rTMS (SCI) | The Jebsen Taylor Hand Function Test (JTT) | Baseline | 74.1 Time (seconds) | Standard Deviation 21.6 |
| Wrist Flexion and Precision Grip + rTMS (SCI) | The Jebsen Taylor Hand Function Test (JTT) | Post 5 training sessions | 54.4 Time (seconds) | Standard Deviation 13.9 |
| Wrist Flexion and Precision Grip + rTMS (SCI) | The Jebsen Taylor Hand Function Test (JTT) | Post all training sessions | 44.8 Time (seconds) | Standard Deviation 15.2 |
| Wrist Flexion and Precision Grip + Sham rTMS (SCI) | The Jebsen Taylor Hand Function Test (JTT) | Baseline | 88.6 Time (seconds) | Standard Deviation 19.6 |
| Wrist Flexion and Precision Grip + Sham rTMS (SCI) | The Jebsen Taylor Hand Function Test (JTT) | Post 5 training sessions | 79.3 Time (seconds) | Standard Deviation 18.7 |
| Wrist Flexion and Precision Grip + Sham rTMS (SCI) | The Jebsen Taylor Hand Function Test (JTT) | Post all training sessions | 84.8 Time (seconds) | Standard Deviation 14.2 |