Spinal Cord Injury
Conditions
Keywords
spike timing dependant plasticity
Brief summary
The overall goal is to develop new clinical approaches to restore limb function after spinal cord injury (SCI). Corticospinal tract (CST) axons are involved in controlling limb function. Paired pulse induced spike-timing dependent plasticity (STDP) enhances synaptic strength between residual CST axons and spinal motoneurons (SMNs) resulting in temporary improvements in limb function in humans with incomplete SCI. Motor training will be combined with paired-pulse STDP stimulation to further enhance plasticity and behavioral recovery.
Detailed description
To induce STDP with paired pulse, corticospinal volleys evoked by either transcranial magnetic stimulation over the primary motor cortex for upper extremities or electrical stimulation over the thoracic spine for lower extremities arrive at corticospinal-motor neuronal synapses of upper- or lower-limb muscles, 1-2 ms before antidromic potentials were elicited in motor neurons by electrical stimulation of corresponding peripheral nerves.
Interventions
OTHERSTDP
Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.
BEHAVIORALTraining
The participant will be asked to perform exercises using their hands and arms.
OTHERSham STDP
Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times.
OTHERMultisite-STDP
Paired stimulation will be given to the brain bilaterally, thoracic spine, and several peripheral nerve so that the messages are received at the spinal cord at predetermined time.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
participants will not know if they receive real or sham stimulation
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
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 * SCI ( 6 months of injury) * Spinal Cord injury at or above L5 * The ability to produce a visible precision grip force with one hand * Able to perform some small wrist flexion and extension * The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles * No subjects will be excluded based on their race, religion, ethnicity, gender or HIV status. * ASIA A,B,C, or D
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment | Measured at baseline, after 10-20 sessions, and follow up (after 6 months) for STDP, STDP+Training, and Sham-STDP+Training groups . Measured at baseline, after 20 and 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group. | The Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) assessment is a standardized test of functional abilities of the hand. We measure time required to complete the GRASSP test for upper extremity functional assessment. 10-m walk test is used to measure walking speed for lower extremity functional assessment. The time to complete the task is assessed in seconds for both measurements and normalized as percentage of Baseline. Normalization to baseline allows comparison across two different tasks. For STDP, STDP+Training, and Sham-STDP+Training groups, either GRASSP or 10-m walk test was performed in each participant depending on the targeted muscle. For Multisite-STDP + Training group, both GRASSP and 10-m walk test were performed in each participant and the average of two tests were reported below. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Voluntary Contraction | Measured at baseline, after 10-20 sessions, and follow up (after 6 months) for STDP, STDP+Training, and Sham-STDP+Training groups . Measured at baseline and after 20 and 40 sessions for Multisite-STDP + Training group. | We measure maximum voluntary contraction (MVC) of muscles recorded by electromyography (EMG) in the targeted muscle(s). Average of muscles was reported for Multisite-STDP + Training group. The maximum voluntary contraction is assessed in millivolts and normalized as percentage of Baseline. Normalization to baseline is needed to allow comparison across different muscles because the targeted muscle is different for each individual depending on the level of injury. |
| ISNCSCI-motor Scores | ISNCSCI was performed at baseline and after 40 sessions of Multisite-STDP+Training. | Neurological recovery was measured by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. Motor part of the exam is completed through the testing of key muscle functions corresponding to 10 myotomes (C5-T1 and L2-S1) for right and left side separately. The strength of each muscle function is graded on a six-point scale ranging from 0 meaning complete paralysis to 5 meaning full strength. The total motor score is sum of all motor scores across 10 myotomes for both sides and therefore ranges from 0-100. Higher scores represent better outcome. We reported the total motor score. |
| ISNCSCI-sensory Scores | ISNCSCI was performed at baseline and after 40 sessions of Multisite-STDP+Training. | Neurological recovery was measured by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. Sensory part of the exam is completed through the testing of a key point in each of the 28 dermatomes (from C2 to S4-5) on the right and left sides of the body. At each of these key points, two aspects of sensation are examined: light touch and pin prick (sharp-dull discrimination). Appreciation of light touch and pin prick sensation at each of the key points is separately scored on a three-point scale; 0-absent, 1-altered, and 2-normal or intact. Therefore, 56 is the maximum score for both light touch and pin prick and the total sensory score ranges from 0 to 112. Higher scores represent better outcome. We reported the total sensory score. |
| Amplitude of Motor Evoked Potential (MEP) | Measured at baseline, after 10-20 sessions, and follow up (after 6 months) for STDP, STDP+Training, and Sham-STDP+Training groups . Measured at baseline and after 20 and 40 sessions for Multisite-STDP + Training group. | We measure amplitude of a motor evoked potential evoked by transcranial magnetic stimulation (TMS) or thoracic spine stimulation. The amplitude of MEP is assessed in millivolts and normalized as percentage of Baseline. Normalization to baseline is necessary to allow comparison across different muscles because the targeted muscle is different for each individual depending on the level of injury. |
| SCI-QOL-self-care | Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group. | We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Self-care subdomain assesses an individual's ability to perform daily self-care activities such as eating, dressing, grooming, and bathing. Higher scores on Self-care subdomain represent better outcome. |
| SCI-QOL- Bowel Management Difficulties | Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group. | We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Bowel management difficulties subdomain measures a range of difficulties associated with bowel management, including an ability to carry out a bowel program; concerns about incontinence and bowel accidents; concerns about difficulty implementing a bowel program; and the impact of bowel management on everyday living. Higher scores on bowel management difficulties subdomain represent better outcome. |
| SCI-QOL- Bladder Management Difficulties | Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group. | We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Bladder management difficulties subdomain measures a range of difficulties associated with bladder management, including ability to carry out a bladder program; worry about bladder accidents; concerns about implementing one's bladder program; and impact on everyday living. Higher scores on bladder management difficulties subdomain represent better outcome. |
| SCI-QOL-ambulation | Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group. | We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Ambulation subdomain assesses the ability to engage in walking activities in different locations that vary based on speed, time and condition and the ability to manage stairs under different conditions. Higher scores on Ambulation subdomain represent better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| STDP Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.
STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.
Participants will complete 10 STDP study visits each lasting \
2 hours.
Baseline and post 10 measurements will be collected for the following measurements:
Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.
Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.
Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements. | 13 |
| STDP + Training Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.
STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.
Training: The participant will be asked to perform exercises using their upper and lower extremities.
Participants will complete 10 STDP + Training study visits each lasting \
2 hours.
Baseline and post 10 measurements will be collected for the following measurements:
Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.
Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.
Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements. | 13 |
| Sham STDP + Training Sham or fake paired stimulation (Sham STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. Motor training will follow stimulation.
Training: The participant will be asked to perform exercises using their upper and lower extremities.
Sham STDP: Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times.
Participants will complete 10 Sham STDP + Training study visits each lasting \
2 hours.
Baseline and post 10 measurements will be collected for the following measurements:
Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.
Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.
Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements. | 12 |
| Multisite-STDP + Training Prospective Single Cohort Multisite-Paired stimulation (Multisite-STDP) will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation.
Multisite-STDP: Paired stimulation will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time.
Training: The participant will be asked to perform exercises using their upper and lower extremities.
Participants will complete 40 multisite-STDP + Training study visits each lasting \
2 hours.
Baseline, post 20, and post 40 measurements will be collected for the following measurements:
Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.
Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.
Baseline and post 40 measurements will be collected for the following measurements:
ISNCSCI, will measure neurologic and functional recovery; SCI-QOL, will measure changes in quality of life functions.
Follow-up measurements will be done after 9 months with available participants for GRASSP, 10-m walk test, and SCI-QOL. | 11 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Some subjects did not like the stimulation. | 4 | 0 | 0 | 2 |
| Overall Study | Some subjects were unable to commit to the training study. | 0 | 3 | 4 | 0 |
Baseline characteristics
| Characteristic | STDP | STDP + Training | Sham STDP + Training | Multisite-STDP + Training | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 0 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 11 Participants | 12 Participants | 8 Participants | 43 Participants |
| Age, Continuous | 45.1 years | 45.6 years | 41.8 years | 48.2 years | 45 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 8 Participants | 6 Participants | 2 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 5 Participants | 6 Participants | 9 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 5 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 5 Participants | 4 Participants | 1 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 3 Participants | 3 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants | 0 Participants | 8 Participants | 18 Participants |
| Region of Enrollment United States | 13 Participants | 13 Participants | 12 Participants | 11 Participants | 49 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 1 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 11 Participants | 6 Participants | 35 Participants |
| Time post injury | 7.1 years STANDARD_DEVIATION 5.4 | 12.7 years STANDARD_DEVIATION 12.5 | 9.1 years STANDARD_DEVIATION 6.1 | 8.9 years STANDARD_DEVIATION 10.6 | 9.5 years STANDARD_DEVIATION 9.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 | 0 / 16 | 0 / 13 |
| other Total, other adverse events | 0 / 17 | 0 / 16 | 0 / 16 | 0 / 13 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 | 0 / 16 | 0 / 13 |
Outcome results
Primary
Functional Assessment
The Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) assessment is a standardized test of functional abilities of the hand. We measure time required to complete the GRASSP test for upper extremity functional assessment. 10-m walk test is used to measure walking speed for lower extremity functional assessment. The time to complete the task is assessed in seconds for both measurements and normalized as percentage of Baseline. Normalization to baseline allows comparison across two different tasks. For STDP, STDP+Training, and Sham-STDP+Training groups, either GRASSP or 10-m walk test was performed in each participant depending on the targeted muscle. For Multisite-STDP + Training group, both GRASSP and 10-m walk test were performed in each participant and the average of two tests were reported below.
Time frame: Measured at baseline, after 10-20 sessions, and follow up (after 6 months) for STDP, STDP+Training, and Sham-STDP+Training groups . Measured at baseline, after 20 and 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group.
Population: The number of participants analyzed is different from overall number of participants because some participants could not perform the GRASSP and/or 10-m walk test. Follow-up was performed only with available participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STDP | Functional Assessment | Baseline | 100 percentage of Baseline | Standard Deviation 0 |
| STDP | Functional Assessment | After 10 sessions | 80.5 percentage of Baseline | Standard Deviation 9.1 |
| STDP + Training | Functional Assessment | After 10 sessions | 75.6 percentage of Baseline | Standard Deviation 18.6 |
| STDP + Training | Functional Assessment | Baseline | 100 percentage of Baseline | Standard Deviation 0 |
| STDP + Training | Functional Assessment | Follow-up | 78.4 percentage of Baseline | Standard Deviation 9.6 |
| Sham STDP + Training | Functional Assessment | After 10 sessions | 82.6 percentage of Baseline | Standard Deviation 20.1 |
| Sham STDP + Training | Functional Assessment | Baseline | 100 percentage of Baseline | Standard Deviation 0 |
| Sham STDP + Training | Functional Assessment | Follow-up | 100.6 percentage of Baseline | Standard Deviation 10.5 |
| Multisite-STDP + Training | Functional Assessment | After 40 sessions | 49.1 percentage of Baseline | Standard Deviation 10.9 |
| Multisite-STDP + Training | Functional Assessment | Baseline | 100 percentage of Baseline | Standard Deviation 0 |
| Multisite-STDP + Training | Functional Assessment | Follow-up | 48.3 percentage of Baseline | Standard Deviation 16.5 |
| Multisite-STDP + Training | Functional Assessment | After 20 sessions | 62.4 percentage of Baseline | Standard Deviation 10.9 |
Secondary
Amplitude of Motor Evoked Potential (MEP)
We measure amplitude of a motor evoked potential evoked by transcranial magnetic stimulation (TMS) or thoracic spine stimulation. The amplitude of MEP is assessed in millivolts and normalized as percentage of Baseline. Normalization to baseline is necessary to allow comparison across different muscles because the targeted muscle is different for each individual depending on the level of injury.
Time frame: Measured at baseline, after 10-20 sessions, and follow up (after 6 months) for STDP, STDP+Training, and Sham-STDP+Training groups . Measured at baseline and after 20 and 40 sessions for Multisite-STDP + Training group.
Population: Follow up was done with available participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STDP | Amplitude of Motor Evoked Potential (MEP) | After 10 sessions | 153.2 percentage of Baseline | Standard Deviation 40.7 |
| STDP | Amplitude of Motor Evoked Potential (MEP) | Baseline | 100 percentage of Baseline | Standard Deviation 0 |
| STDP + Training | Amplitude of Motor Evoked Potential (MEP) | Baseline | 100 percentage of Baseline | Standard Deviation 0 |
| STDP + Training | Amplitude of Motor Evoked Potential (MEP) | After 10 sessions | 164.6 percentage of Baseline | Standard Deviation 64 |
| STDP + Training | Amplitude of Motor Evoked Potential (MEP) | Follow-up | 172 percentage of Baseline | Standard Deviation 57.7 |
| Sham STDP + Training | Amplitude of Motor Evoked Potential (MEP) | Follow-up | 89.0 percentage of Baseline | Standard Deviation 22.1 |
| Sham STDP + Training | Amplitude of Motor Evoked Potential (MEP) | After 10 sessions | 99.1 percentage of Baseline | Standard Deviation 12.4 |
| Sham STDP + Training | Amplitude of Motor Evoked Potential (MEP) | Baseline | 100 percentage of Baseline | Standard Deviation 0 |
| Multisite-STDP + Training | Amplitude of Motor Evoked Potential (MEP) | After 20 sessions | 233.2 percentage of Baseline | Standard Deviation 65.9 |
| Multisite-STDP + Training | Amplitude of Motor Evoked Potential (MEP) | After 40 sessions | 368.9 percentage of Baseline | Standard Deviation 108.9 |
| Multisite-STDP + Training | Amplitude of Motor Evoked Potential (MEP) | Baseline | 100 percentage of Baseline | Standard Deviation 0 |
Secondary
ISNCSCI-motor Scores
Neurological recovery was measured by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. Motor part of the exam is completed through the testing of key muscle functions corresponding to 10 myotomes (C5-T1 and L2-S1) for right and left side separately. The strength of each muscle function is graded on a six-point scale ranging from 0 meaning complete paralysis to 5 meaning full strength. The total motor score is sum of all motor scores across 10 myotomes for both sides and therefore ranges from 0-100. Higher scores represent better outcome. We reported the total motor score.
Time frame: ISNCSCI was performed at baseline and after 40 sessions of Multisite-STDP+Training.
Population: We performed ISNCSCI exam only for Multiside-STDP+training group but not in the other groups (STDP, STDP + Training and Sham STDP + Training). Therefore the results were provided only for Multiside-STDP+training group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STDP | ISNCSCI-motor Scores | Baseline | 59.4 scores on a scale | Standard Deviation 23.7 |
| STDP | ISNCSCI-motor Scores | After 40 sessions | 68.9 scores on a scale | Standard Deviation 20.2 |
Secondary
ISNCSCI-sensory Scores
Neurological recovery was measured by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. Sensory part of the exam is completed through the testing of a key point in each of the 28 dermatomes (from C2 to S4-5) on the right and left sides of the body. At each of these key points, two aspects of sensation are examined: light touch and pin prick (sharp-dull discrimination). Appreciation of light touch and pin prick sensation at each of the key points is separately scored on a three-point scale; 0-absent, 1-altered, and 2-normal or intact. Therefore, 56 is the maximum score for both light touch and pin prick and the total sensory score ranges from 0 to 112. Higher scores represent better outcome. We reported the total sensory score.
Time frame: ISNCSCI was performed at baseline and after 40 sessions of Multisite-STDP+Training.
Population: We performed ISNCSCI exam only for Multiside-STDP+training group but not in the other groups (STDP, STDP + Training and Sham STDP + Training). Therefore the results were provided only for Multiside-STDP+training group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STDP | ISNCSCI-sensory Scores | Baseline | 99.0 scores on a scale | Standard Deviation 34.6 |
| STDP | ISNCSCI-sensory Scores | After 40 sessions | 119.9 scores on a scale | Standard Deviation 38.4 |
Secondary
Maximum Voluntary Contraction
We measure maximum voluntary contraction (MVC) of muscles recorded by electromyography (EMG) in the targeted muscle(s). Average of muscles was reported for Multisite-STDP + Training group. The maximum voluntary contraction is assessed in millivolts and normalized as percentage of Baseline. Normalization to baseline is needed to allow comparison across different muscles because the targeted muscle is different for each individual depending on the level of injury.
Time frame: Measured at baseline, after 10-20 sessions, and follow up (after 6 months) for STDP, STDP+Training, and Sham-STDP+Training groups . Measured at baseline and after 20 and 40 sessions for Multisite-STDP + Training group.
Population: Follow-up was done only with available participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STDP | Maximum Voluntary Contraction | After 10 sessions | 139.4 percentage of Baseline | Standard Deviation 23.3 |
| STDP | Maximum Voluntary Contraction | Baseline | 100 percentage of Baseline | Standard Deviation 0 |
| STDP + Training | Maximum Voluntary Contraction | Baseline | 100 percentage of Baseline | Standard Deviation 0 |
| STDP + Training | Maximum Voluntary Contraction | After 10 sessions | 144.6 percentage of Baseline | Standard Deviation 50.7 |
| STDP + Training | Maximum Voluntary Contraction | follow-up | 154.5 percentage of Baseline | Standard Deviation 25 |
| Sham STDP + Training | Maximum Voluntary Contraction | follow-up | 108.8 percentage of Baseline | Standard Deviation 7.8 |
| Sham STDP + Training | Maximum Voluntary Contraction | After 10 sessions | 100.7 percentage of Baseline | Standard Deviation 12.3 |
| Sham STDP + Training | Maximum Voluntary Contraction | Baseline | 100 percentage of Baseline | Standard Deviation 0 |
| Multisite-STDP + Training | Maximum Voluntary Contraction | After 20 sessions | 161.0 percentage of Baseline | Standard Deviation 49.5 |
| Multisite-STDP + Training | Maximum Voluntary Contraction | After 40 sessions | 193.1 percentage of Baseline | Standard Deviation 71 |
| Multisite-STDP + Training | Maximum Voluntary Contraction | Baseline | 100 percentage of Baseline | Standard Deviation 0 |
Secondary
SCI-QOL-ambulation
We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Ambulation subdomain assesses the ability to engage in walking activities in different locations that vary based on speed, time and condition and the ability to manage stairs under different conditions. Higher scores on Ambulation subdomain represent better outcome.
Time frame: Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group.
Population: We performed SCI-QOL exam only for Multiside-STDP+training group but not in the other groups (STDP, STDP + Training and Sham STDP + Training). Therefore the results were provided only for Multiside-STDP+training group. Follow up was done with available participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STDP | SCI-QOL-ambulation | Baseline | 53.7 T-scores | Standard Deviation 9.4 |
| STDP | SCI-QOL-ambulation | After 40 sessions | 57.1 T-scores | Standard Deviation 7.9 |
| STDP | SCI-QOL-ambulation | Follow-up | 61.4 T-scores | Standard Deviation 5.3 |
Secondary
SCI-QOL- Bladder Management Difficulties
We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Bladder management difficulties subdomain measures a range of difficulties associated with bladder management, including ability to carry out a bladder program; worry about bladder accidents; concerns about implementing one's bladder program; and impact on everyday living. Higher scores on bladder management difficulties subdomain represent better outcome.
Time frame: Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group.
Population: We performed SCI-QOL exam only for Multiside-STDP+training group but not in the other groups (STDP, STDP + Training and Sham STDP + Training). Therefore the results were provided only for Multiside-STDP+training group. Follow up was done with available participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STDP | SCI-QOL- Bladder Management Difficulties | Baseline | 41.0 T-scores | Standard Deviation 9.5 |
| STDP | SCI-QOL- Bladder Management Difficulties | After 40 sessions | 46.7 T-scores | Standard Deviation 7.6 |
| STDP | SCI-QOL- Bladder Management Difficulties | Follow-up | 40.9 T-scores | Standard Deviation 7.6 |
Secondary
SCI-QOL- Bowel Management Difficulties
We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Bowel management difficulties subdomain measures a range of difficulties associated with bowel management, including an ability to carry out a bowel program; concerns about incontinence and bowel accidents; concerns about difficulty implementing a bowel program; and the impact of bowel management on everyday living. Higher scores on bowel management difficulties subdomain represent better outcome.
Time frame: Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group.
Population: We performed SCI-QOL exam only for Multiside-STDP+training group but not in the other groups (STDP, STDP + Training and Sham STDP + Training). Therefore the results were provided only for Multiside-STDP+training group. Follow up was done with available participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STDP | SCI-QOL- Bowel Management Difficulties | Baseline | 48.2 T-scores | Standard Deviation 10.6 |
| STDP | SCI-QOL- Bowel Management Difficulties | After 40 sessions | 51.8 T-scores | Standard Deviation 10.7 |
| STDP | SCI-QOL- Bowel Management Difficulties | Follow-up | 45.4 T-scores | Standard Deviation 7.3 |
Secondary
SCI-QOL-self-care
We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Self-care subdomain assesses an individual's ability to perform daily self-care activities such as eating, dressing, grooming, and bathing. Higher scores on Self-care subdomain represent better outcome.
Time frame: Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group.
Population: We performed SCI-QOL exam only for Multiside-STDP+training group but not in the other groups (STDP, STDP + Training and Sham STDP + Training). Therefore the results were provided only for Multiside-STDP+training group. Follow up was done with available participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STDP | SCI-QOL-self-care | Baseline | 45.9 T-scores | Standard Deviation 7.8 |
| STDP | SCI-QOL-self-care | After 40 sessions | 47.5 T-scores | Standard Deviation 8 |
| STDP | SCI-QOL-self-care | Follow-up | 48.5 T-scores | Standard Deviation 3.6 |