An interventional study of rTMS and Sham rTMS in Spinal Cord Injury, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 42 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
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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:
Participants who have had a spinal cord injury:
Exclusion Criteria:
Exclusion criteria for enrollment For SCI and Healthy Control Subjects (for stimulation):
Participants will be asked to complete a precision grip with the index and thumb finger at the same time as flexing or extending the wrist. magnetic stimulation to the brain will be administered and measurements will be taken during movement.
Device: rTMS · Device: Sham rTMS · Other: Motor Task
Participant will be randomly assigned to one of 3 groups: repetitive transcranial magnetic stimulation (rTMS), sham (fake) rTMS, or sham (fake) rTMS over control brain area will be administered to the brain. the stimulation will be targeting finger and wrist muscles during movement.
Device: rTMS · Device: 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.
Device: rTMS · Device: Sham rTMS · Other: Training
small magnetic pulses will be given to the brain in a non invasive manner.
sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner
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
participants will be asked to perform specific motor tasks or movements with their fingers, hands, arms or legs.
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
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)
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.
| Milestone | Wrist Flexion and Precision Grip + rTMS and Sham rTMS | Wrist Extension and Precision Grip + rTMS and Sham rTMS | rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | Training + rTMS | Training + Sham rTMS |
|---|---|---|---|---|---|
| Started | 10 | 10 | 5 | 8 | 9 |
| Sci | 5 | 5 | 5 | 8 | 9 |
| Control | 5 | 5 | 0 | 0 | 0 |
| Completed | 10 | 10 | 5 | 4 | 3 |
| Not completed | 0 | 0 | 0 | 4 | 6 |
| Withdrew: Some subjects were unable to commit to the training study. | 0 | 0 | 0 | 4 | 6 |
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.
| millivolts (mV) | Wrist Flexion and Precision Grip + rTMS (SCI) | Wrist Flexion and Precision Grip + Sham rTMS (SCI) | Wrist Flexion and Precision Grip + rTMS (Control) | Wrist Flexion and Precision Grip + Sham rTMS (Control) | Wrist Extension and Precision Grip + rTMS (SCI) | Wrist Extension and Precision Grip + Sham rTMS (SCI) | Wrist Extension and Precision Grip + rTMS (Control) | Wrist Extension and Precision Grip + Sham rTMS (Control) | rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | Training + rTMS | Training + Sham rTMS |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Before: minute 0 | 0.31 ± 0.52 | 0.43 ± 0.77 | 0.45 ± 0.81 | 0.65 ± 1.12 | 0.33 ± 0.92 | 0.44 ± 0.61 | 0.59 ± 0.98 | 0.52 ± 0.83 | — | — | — |
| Before: minute 10 | 0.33 ± 0.56 | 0.39 ± 0.88 | 0.47 ± 1.12 | 0.71 ± 1.08 | 0.37 ± 0.83 | 0.46 ± 0.72 | 0.66 ± 1.02 | 0.56 ± 1.06 | — | — | — |
| Before: minute 30 | 0.36 ± 0.83 | 0.41 ± 0.80 | 0.51 ± 0.52 | 0.68 ± 0.91 | 0.42 ± 1.17 | 0.45 ± 0.93 | 0.63 ± 1.07 | 0.53 ± 0.92 | — | — | — |
| Before: minute 60 | 0.39 ± 1.02 | 0.42 ± 0.65 | 0.53 ± 0.85 | 0.72 ± 1.15 | 0.45 ± 0.98 | 0.42 ± 1.02 | 0.65 ± 0.97 | 0.61 ± 0.82 | — | — | — |
| After: minute 0 | 0.36 ± 1.03 | 0.45 ± 0.81 | 0.49 ± 1.26 | 0.66 ± 0.82 | 0.44 ± 0.67 | 0.61 ± 0.98 | 0.66 ± 1.03 | 0.57 ± 0.91 | — | — | — |
| After: minute 10 | 0.35 ± 0.83 | 0.44 ± 0.79 | 0.51 ± 0.35 | 0.71 ± 1.13 | 0.41 ± 1.02 | 0.59 ± 1.03 | 0.71 ± 0.98 | 0.63 ± 0.70 | — | — | — |
| After: minute 30 | 0.50 ± 1.44 | 0.43 ± 0.61 | 0.50 ± 0.81 | 0.73 ± 0.91 | 0.42 ± 0.91 | 0.63 ± 1.12 | 0.72 ± 1.04 | 0.61 ± 1.02 | — | — | — |
| After: minute 60 | 0.55 ± 1.18 | 0.44 ± 0.71 | 0.55 ± 0.33 | 0.74 ± 0.78 | 0.46 ± 0.88 | 0.66 ± 0.98 | 0.74 ± 1.12 | 0.62 ± 0.87 | — | — | — |
| Session 1: minute 0 | — | — | — | — | — | — | — | — | 0.41 ± 0.52 | — | — |
| Session 1: minute 10 | — | — | — | — | — | — | — | — | 0.47 ± 0.91 | — | — |
| Session 1: minute 30 | — | — | — | — | — | — | — | — | 0.49 ± 0.82 | — | — |
| Session 1: minute 60 | — | — | — | — | — | — | — | — | 0.52 ± 0.70 | — | — |
| Session 2: minute 0 | — | — | — | — | — | — | — | — | 0.59 ± 0.98 | — | — |
| Session 2: minute 10 | — | — | — | — | — | — | — | — | 0.54 ± 0.77 | — | — |
| Session 2: minute 30 | — | — | — | — | — | — | — | — | 0.61 ± 1.03 | — | — |
| Session 2: minute 60 | — | — | — | — | — | — | — | — | 0.58 ± 0.95 | — | — |
| Session 3: minute 0 | — | — | — | — | — | — | — | — | 0.66 ± 1.02 | — | — |
| Session 3: minute 10 | — | — | — | — | — | — | — | — | 0.67 ± 0.98 | — | — |
| Session 3: minute 30 | — | — | — | — | — | — | — | — | 0.69 ± 1.28 | — | — |
| Session 3: minute 60 | — | — | — | — | — | — | — | — | 0.70 ± 1.02 | — | — |
| Baseline | — | — | — | — | — | — | — | — | — | 0.61 ± 0.79 | 0.61 ± 0.80 |
| Post 5 training sessions | — | — | — | — | — | — | — | — | — | 0.70 ± 0.92 | 0.68 ± 0.74 |
| Post all training sessions | — | — | — | — | — | — | — | — | — | 0.80 ± 0.83 | 0.69 ± 0.88 |
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.
| Millivolts (mV) | rTMS, Sham rTMS, Sham rTMS Over Control Brain Area |
|---|---|
| Session 1: Before | 0.138 ± 0.239 |
| Session 1: After | 0.191 ± 0.323 |
| Session 2: Before | 0.204 ± 0.361 |
| Session 2: After | 0.208 ± 0.384 |
| Session 3: Before | 0.221 ± 0.329 |
| Session 3: After | 0.231 ± 0.352 |
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 (seconds) | Training + rTMS | Training + Sham rTMS |
|---|---|---|
| Baseline | 74.1 ± 21.6 | 88.6 ± 19.6 |
| Post 5 training sessions | 54.4 ± 13.9 | 79.3 ± 18.7 |
| Post all training sessions | 44.8 ± 15.2 | 84.8 ± 14.2 |
Collected over The adverse event data was collected from baseline to completion of study visits for each participant, an average of 6 days for Arm 1 and an average of 3 weeks for Arm 2 and 3.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Wrist Flexion and Precision Grip + rTMS and Sham rTMS | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Wrist Extension and Precision Grip + rTMS and Sham rTMS | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Training + rTMS | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Training + Sham rTMS | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Wrist Flexion and Precision Grip + rTMS and Sham rTMS (SCI) | 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 | Total |
|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 5 | 5 | 5 | 5 | 4 | 3 | 32 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Wrist Flexion and Precision Grip + rTMS and Sham rTMS (SCI) | 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 | Total |
|---|---|---|---|---|---|---|---|---|
| Median | 44 (30 to 58) | 48 (26 to 56) | 53 (37 to 58) | 51 (41 to 56) | 43 (23 to 61) | 45 (33 to 56) | 41 (30 to 55) | 45 (23 to 61) |
| Sex: Female, Male(Participants) | Wrist Flexion and Precision Grip + rTMS and Sham rTMS (SCI) | 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 | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 0 | 2 | 3 | 1 | 1 | 1 | 0 | 8 |
| Male | 5 | 3 | 2 | 4 | 4 | 3 | 3 | 24 |
| Ethnicity (NIH/OMB)(Participants) | Wrist Flexion and Precision Grip + rTMS and Sham rTMS (SCI) | 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 | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 4 | 4 | 1 | 4 | 3 | 2 | 21 |
| Not Hispanic or Latino | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 8 |
| Unknown or Not Reported | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 3 |
| Race (NIH/OMB)(Participants) | Wrist Flexion and Precision Grip + rTMS and Sham rTMS (SCI) | 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 | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 2 |
| Black or African American | 1 | 3 | 1 | 2 | 3 | 2 | 2 | 14 |
| White | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 4 |
| More than one race | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 8 |
| Unknown or Not Reported | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 3 |
| Region of Enrollment(Participants) | Wrist Flexion and Precision Grip + rTMS and Sham rTMS (SCI) | 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 | Total |
|---|---|---|---|---|---|---|---|---|
| United States | 5 | 5 | 5 | 5 | 5 | 4 | 3 | 32 |
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