Acquired Brain Injury
Conditions
Brief summary
This study will compare different polarities of transcutaneous spinal direct current stimulation combined with robotic-assisted arm training (RAT) in adults with acquired brain injury (ABI). Participants will receive 20 minutes of 2.5 milliamps (mA) anodal, cathodal, and sham transpinal direct current stimulation (tsDCS) over cervical spine combined with high intensity robotic-assisted arm training, five days a week, for 2 consecutive weeks.
Detailed description
Acquired brain injury (ABI) is the leading cause of neurological disability in the United States and accounts for the poor physical health and the social dysfunction evident in survivors. Hemiparesis due to acquired brain injury is the primary cause of disability and arm paresis is perceived as the primary cause of disability by individuals who have suffered ABI because of the limitations it creates in performing activities of daily living (ADL). Rehabilitation of the impaired limb is essential for improving motor function after ABI, yet only 31% of ABI survivors receive outpatient rehabilitation. Therefore, effective therapy for upper-limb paresis must be addressed. Approximately 80% of all ABI survivors suffer from upper limb paresis and only 18% of these individuals gain full motor recovery with conventional treatments in the year following ABI. The study will use cross-over, randomized, sham controlled, double-blinded design. Participants with subacute or chronic ABI will each be assigned to receive active anodal spinal stimulation, active cathodal spinal stimulation, and sham spinal stimulation for the same duration, and the order that each participant will receive anodal, cathodal, and sham stimulation will be randomized. In all the experiments participants will receive robotic assisted training for duration of 1.5 hours. The first 20 minutes of training will be coupled with spinal stimulation. Treatment will be administered at an intensity of 5 sessions per week for 2 weeks.
Interventions
DEVICEtsDCS-Anodal Stimulation
2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
DEVICEtsDCS-Cathodal Stimulation
2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
DEVICEtsDCS-Sham Stimulation
2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
DEVICERobotic-assisted training of arm and hand functions
70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Each participant will receive active anodal spinal stimulation, active cathodal spinal stimulation, and sham spinal stimulation. The order that each participant receives anodal, cathodal, and sham stimulation will be randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Providing written informed consent prior to any study related procedures; 2. Age above 18; 3. Diagnosis of acquired brain injury at least for 6 month 4. No neuropsychiatric comorbidities 5. Not being involved in any specific exercise program (e.g., neuromuscular electrical stimulation (NMES), functional electrical stimulation (FES)) within the previous 3 months; 6. No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study; 7. Eligibility for standard upper-extremity rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation); 8. No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid administration of the measures or with interpreting motor testing; 9. No contraindications to tsDCS: * metal in the head between stimulation area * metal in the spine between stimulation area * implanted brain medical devices 10. No pregnancy; 11. No contraindications for Transcranial Magnetic Stimulation (TMS) and magnetic resonance imaging (MRI) based on TMS and MRI screening forms
Exclusion criteria
1. Uncontrolled epilepsy; 2. Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score \> than 3 out of 4; 3. History of substance abuse; 4. Subject who cannot provide self-transportation to the study location
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Arm (FMA) Motor Score | baseline | FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pinch Strength | Baseline | A pinch gauge will be used to measure maximum pinch force. |
| Quantitative Movement Measurement | Change from baseline at 2 weeks and at 1 month | Robotic movement data will be used to quantitatively measure changes in movement smoothness |
| Number of Participants With Adverse Effects Related to tsDCS | Baseline | Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded. |
| Grip Strength | baseline | A grip dynamometer will be used to measure maximum gross grasp force. |
| Spasticity as Assessed by the Modified Ashworth Scale (MAS) | baseline | This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in the trained upper limb. |
| Neurophysiologic Testing for Spinal Conductivity (SSEP) | Change from baseline at 2 weeks and at 1 month | — |
| Change in Strength of Selective Muscle Groups | Change from baseline at 2 weeks and at 1 month | — |
| Jebsen Taylor Hand Function Test (JTHFT) | Baseline | The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second. |
| Action Research Arm Test (ARAT) | Baseline | The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance. |
| Motor Activity Log (MAL) | Baseline | The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm. |
| Spinal Reflexes | Change from baseline at 2 weeks and at 1 month | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants tsDCS-Anodal Stimulation & robotic-assisted training (RAT) of arm and hand functions: 2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
tsDCS-Cathodal Stimulation & robotic-assisted training (RAT) of arm and hand functions: 2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
tsDCS-Sham Stimulation & robotic-assisted training (RAT) of arm and hand functions: 2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| First Intervention (2 Weeks) | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 56.5 years STANDARD_DEVIATION 6.3 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Participants |
| Race/Ethnicity, Customized More than One Race | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized White | 2 Participants |
| Region of Enrollment United States | 9 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 0 / 7 |
Outcome results
Primary
Fugl-Meyer Arm (FMA) Motor Score
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
Time frame: 2 weeks
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Fugl-Meyer Arm (FMA) Motor Score | 43.1 score on a scale | Standard Deviation 13.4 |
| tsDCS- Cathodal Stimulation & RAT | Fugl-Meyer Arm (FMA) Motor Score | 40.6 score on a scale | Standard Deviation 13.4 |
| tsDCS- Sham Stimulation & RAT | Fugl-Meyer Arm (FMA) Motor Score | 44.2 score on a scale | Standard Deviation 14.1 |
Primary
Fugl-Meyer Arm (FMA) Motor Score
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
Time frame: 1 month
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Fugl-Meyer Arm (FMA) Motor Score | 42.4 score on a scale | Standard Deviation 14.7 |
| tsDCS- Cathodal Stimulation & RAT | Fugl-Meyer Arm (FMA) Motor Score | 42 score on a scale | Standard Deviation 12.3 |
| tsDCS- Sham Stimulation & RAT | Fugl-Meyer Arm (FMA) Motor Score | 44.4 score on a scale | Standard Deviation 13.5 |
Primary
Fugl-Meyer Arm (FMA) Motor Score
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
Time frame: baseline
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Fugl-Meyer Arm (FMA) Motor Score | 42 score on a scale | Standard Deviation 13.8 |
| tsDCS- Cathodal Stimulation & RAT | Fugl-Meyer Arm (FMA) Motor Score | 40 score on a scale | Standard Deviation 12.8 |
| tsDCS- Sham Stimulation & RAT | Fugl-Meyer Arm (FMA) Motor Score | 42.8 score on a scale | Standard Deviation 12.7 |
Secondary
Action Research Arm Test (ARAT)
The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
Time frame: 2 weeks
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Action Research Arm Test (ARAT) | 36.7 score on a scale | Standard Deviation 23.6 |
| tsDCS- Cathodal Stimulation & RAT | Action Research Arm Test (ARAT) | 34.4 score on a scale | Standard Deviation 21.6 |
| tsDCS- Sham Stimulation & RAT | Action Research Arm Test (ARAT) | 40.1 score on a scale | Standard Deviation 22.8 |
Secondary
Action Research Arm Test (ARAT)
The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
Time frame: Baseline
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Action Research Arm Test (ARAT) | 35.2 score on a scale | Standard Deviation 22.8 |
| tsDCS- Cathodal Stimulation & RAT | Action Research Arm Test (ARAT) | 34 score on a scale | Standard Deviation 21.5 |
| tsDCS- Sham Stimulation & RAT | Action Research Arm Test (ARAT) | 37.2 score on a scale | Standard Deviation 23.1 |
Secondary
Action Research Arm Test (ARAT)
The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
Time frame: 1 month
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Action Research Arm Test (ARAT) | 39.5 score on a scale | Standard Deviation 22.7 |
| tsDCS- Cathodal Stimulation & RAT | Action Research Arm Test (ARAT) | 35.1 score on a scale | Standard Deviation 22.5 |
| tsDCS- Sham Stimulation & RAT | Action Research Arm Test (ARAT) | 39 score on a scale | Standard Deviation 23.6 |
Secondary
Change in Strength of Selective Muscle Groups
Time frame: Change from baseline at 2 weeks and at 1 month
Population: Data were not collected for this outcome measure
Secondary
Grip Strength
A grip dynamometer will be used to measure maximum gross grasp force.
Time frame: 1 month
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Grip Strength | 31.4 kg of force | Standard Deviation 18.7 |
| tsDCS- Cathodal Stimulation & RAT | Grip Strength | 22.5 kg of force | Standard Deviation 8.7 |
| tsDCS- Sham Stimulation & RAT | Grip Strength | 29.2 kg of force | Standard Deviation 6 |
Secondary
Grip Strength
A grip dynamometer will be used to measure maximum gross grasp force.
Time frame: 2 weeks
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Grip Strength | 30.1 kg of force | Standard Deviation 19.1 |
| tsDCS- Cathodal Stimulation & RAT | Grip Strength | 21.8 kg of force | Standard Deviation 8.6 |
| tsDCS- Sham Stimulation & RAT | Grip Strength | 31.8 kg of force | Standard Deviation 15.8 |
Secondary
Grip Strength
A grip dynamometer will be used to measure maximum gross grasp force.
Time frame: baseline
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Grip Strength | 27.3 kg of force | Standard Deviation 17 |
| tsDCS- Cathodal Stimulation & RAT | Grip Strength | 22.1 kg of force | Standard Deviation 12.5 |
| tsDCS- Sham Stimulation & RAT | Grip Strength | 30.1 kg of force | Standard Deviation 18.3 |
Secondary
Jebsen Taylor Hand Function Test (JTHFT)
The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
Time frame: 2 weeks
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Jebsen Taylor Hand Function Test (JTHFT) | .25 activities completed per second | Standard Deviation 0.2 |
| tsDCS- Cathodal Stimulation & RAT | Jebsen Taylor Hand Function Test (JTHFT) | .18 activities completed per second | Standard Deviation 0.2 |
| tsDCS- Sham Stimulation & RAT | Jebsen Taylor Hand Function Test (JTHFT) | .26 activities completed per second | Standard Deviation 0.2 |
Secondary
Jebsen Taylor Hand Function Test (JTHFT)
The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
Time frame: Baseline
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Jebsen Taylor Hand Function Test (JTHFT) | .22 activities completed per second | Standard Deviation 0.2 |
| tsDCS- Cathodal Stimulation & RAT | Jebsen Taylor Hand Function Test (JTHFT) | .17 activities completed per second | Standard Deviation 0.2 |
| tsDCS- Sham Stimulation & RAT | Jebsen Taylor Hand Function Test (JTHFT) | .23 activities completed per second | Standard Deviation 0.2 |
Secondary
Jebsen Taylor Hand Function Test (JTHFT)
The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
Time frame: 1 month
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Jebsen Taylor Hand Function Test (JTHFT) | .25 activities completed per second | Standard Deviation 0.2 |
| tsDCS- Cathodal Stimulation & RAT | Jebsen Taylor Hand Function Test (JTHFT) | .2 activities completed per second | Standard Deviation 0.2 |
| tsDCS- Sham Stimulation & RAT | Jebsen Taylor Hand Function Test (JTHFT) | .22 activities completed per second | Standard Deviation 0.2 |
Secondary
Motor Activity Log (MAL)
The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.
Time frame: 2 weeks
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Motor Activity Log (MAL) | 2.17 score on a scale | Standard Deviation 1.4 |
| tsDCS- Cathodal Stimulation & RAT | Motor Activity Log (MAL) | 2.14 score on a scale | Standard Deviation 1.4 |
| tsDCS- Sham Stimulation & RAT | Motor Activity Log (MAL) | 2.07 score on a scale | Standard Deviation 1.1 |
Secondary
Motor Activity Log (MAL)
The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.
Time frame: Baseline
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Motor Activity Log (MAL) | 1.99 score on a scale | Standard Deviation 1.3 |
| tsDCS- Cathodal Stimulation & RAT | Motor Activity Log (MAL) | 2.07 score on a scale | Standard Deviation 1.4 |
| tsDCS- Sham Stimulation & RAT | Motor Activity Log (MAL) | 2.15 score on a scale | Standard Deviation 1.2 |
Secondary
Motor Activity Log (MAL)
The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.
Time frame: 1 month
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Motor Activity Log (MAL) | 2.34 score on a scale | Standard Deviation 1.4 |
| tsDCS- Cathodal Stimulation & RAT | Motor Activity Log (MAL) | 1.86 score on a scale | Standard Deviation 1.6 |
| tsDCS- Sham Stimulation & RAT | Motor Activity Log (MAL) | 2.2 score on a scale | Standard Deviation 1.4 |
Secondary
Neurophysiologic Testing for Spinal Conductivity (SSEP)
Time frame: Change from baseline at 2 weeks and at 1 month
Population: Data were not collected for this outcome measure
Secondary
Number of Participants With Adverse Effects Related to tsDCS
Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.
Time frame: 1 month
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Number of Participants With Adverse Effects Related to tsDCS | 0 Participants |
| tsDCS- Cathodal Stimulation & RAT | Number of Participants With Adverse Effects Related to tsDCS | 0 Participants |
| tsDCS- Sham Stimulation & RAT | Number of Participants With Adverse Effects Related to tsDCS | 0 Participants |
Secondary
Number of Participants With Adverse Effects Related to tsDCS
Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.
Time frame: 2 weeks
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Number of Participants With Adverse Effects Related to tsDCS | 0 Participants |
| tsDCS- Cathodal Stimulation & RAT | Number of Participants With Adverse Effects Related to tsDCS | 0 Participants |
| tsDCS- Sham Stimulation & RAT | Number of Participants With Adverse Effects Related to tsDCS | 0 Participants |
Secondary
Number of Participants With Adverse Effects Related to tsDCS
Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.
Time frame: Baseline
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Number of Participants With Adverse Effects Related to tsDCS | 0 Participants |
| tsDCS- Cathodal Stimulation & RAT | Number of Participants With Adverse Effects Related to tsDCS | 0 Participants |
| tsDCS- Sham Stimulation & RAT | Number of Participants With Adverse Effects Related to tsDCS | 0 Participants |
Secondary
Pinch Strength
A pinch gauge will be used to measure maximum pinch force.
Time frame: 1 month
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Pinch Strength | 10.4 kg of force | Standard Deviation 4.8 |
| tsDCS- Cathodal Stimulation & RAT | Pinch Strength | 11.6 kg of force | Standard Deviation 3.6 |
| tsDCS- Sham Stimulation & RAT | Pinch Strength | 9.5 kg of force | Standard Deviation 3.8 |
Secondary
Pinch Strength
A pinch gauge will be used to measure maximum pinch force.
Time frame: 2 weeks
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Pinch Strength | 12.1 kg of force | Standard Deviation 5.9 |
| tsDCS- Cathodal Stimulation & RAT | Pinch Strength | 11.8 kg of force | Standard Deviation 3.9 |
| tsDCS- Sham Stimulation & RAT | Pinch Strength | 10.9 kg of force | Standard Deviation 4.2 |
Secondary
Pinch Strength
A pinch gauge will be used to measure maximum pinch force.
Time frame: Baseline
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Pinch Strength | 11.2 kg of force | Standard Deviation 6.5 |
| tsDCS- Cathodal Stimulation & RAT | Pinch Strength | 10.92 kg of force | Standard Deviation 11.8 |
| tsDCS- Sham Stimulation & RAT | Pinch Strength | 9.4 kg of force | Standard Deviation 4.9 |
Secondary
Quantitative Movement Measurement
Robotic movement data will be used to quantitatively measure changes in movement smoothness
Time frame: Change from baseline at 2 weeks and at 1 month
Population: Data were not collected for this outcome measure
Secondary
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in the trained upper limb.
Time frame: 2 weeks
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Spasticity as Assessed by the Modified Ashworth Scale (MAS) | .2 score on a scale | Standard Deviation 0.3 |
| tsDCS- Cathodal Stimulation & RAT | Spasticity as Assessed by the Modified Ashworth Scale (MAS) | .3 score on a scale | Standard Deviation 0.2 |
| tsDCS- Sham Stimulation & RAT | Spasticity as Assessed by the Modified Ashworth Scale (MAS) | .3 score on a scale | Standard Deviation 0.2 |
Secondary
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in the trained upper limb.
Time frame: 1 month
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Spasticity as Assessed by the Modified Ashworth Scale (MAS) | .05 score on a scale | Standard Deviation 0.09 |
| tsDCS- Cathodal Stimulation & RAT | Spasticity as Assessed by the Modified Ashworth Scale (MAS) | .2 score on a scale | Standard Deviation 0.2 |
| tsDCS- Sham Stimulation & RAT | Spasticity as Assessed by the Modified Ashworth Scale (MAS) | .3 score on a scale | Standard Deviation 0.3 |
Secondary
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in the trained upper limb.
Time frame: baseline
Population: Data were collected for 7 participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS- Anodal Stimulation & Robotic Arm Training (RAT) | Spasticity as Assessed by the Modified Ashworth Scale (MAS) | .2 score on a scale | Standard Deviation 0.2 |
| tsDCS- Cathodal Stimulation & RAT | Spasticity as Assessed by the Modified Ashworth Scale (MAS) | .4 score on a scale | Standard Deviation 0.4 |
| tsDCS- Sham Stimulation & RAT | Spasticity as Assessed by the Modified Ashworth Scale (MAS) | .3 score on a scale | Standard Deviation 0.3 |
Secondary
Spinal Reflexes
Time frame: Change from baseline at 2 weeks and at 1 month
Population: Data were not collected for this outcome measure