Trial Outcomes & Findings for Improving Motor Function After Spinal Cord Injury (NCT NCT01915095)

NCT ID: NCT01915095

Last Updated: 2021-06-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

Post rTMS, Sham rTMS, and Sham rTMS over control brain for all sessions at minute 0, 10, 30, and 60

Results posted on

2021-06-11

Participant Flow

Participant milestones

Participant milestones
Measure
Wrist Flexion and Precision Grip + rTMS and Sham rTMS
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.
Wrist Extension and Precision Grip + rTMS and Sham rTMS
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.
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.
Training + rTMS
Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 sessions, and Post all training sessions.
Training + Sham rTMS
Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Sham or fake Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 sessions, and Post all training sessions.
Overall Study
STARTED
10
10
5
8
9
Overall Study
SCI
5
5
5
8
9
Overall Study
Control
5
5
0
0
0
Overall Study
COMPLETED
10
10
5
4
3
Overall Study
NOT COMPLETED
0
0
0
4
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Wrist Flexion and Precision Grip + rTMS and Sham rTMS
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.
Wrist Extension and Precision Grip + rTMS and Sham rTMS
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.
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.
Training + rTMS
Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 sessions, and Post all training sessions.
Training + Sham rTMS
Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Sham or fake Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 sessions, and Post all training sessions.
Overall Study
Some subjects were unable to commit to the training study.
0
0
0
4
6

Baseline Characteristics

Improving Motor Function After Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Wrist Flexion and Precision Grip + rTMS and Sham rTMS (SCI)
n=5 Participants
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.
Wrist Flexion and Precision Grip + rTMS and Sham rTMS (Controls)
n=5 Participants
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.
Wrist Extension and Precision Grip + rTMS and Sham rTMS (SCI)
n=5 Participants
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.
Wrist Extension and Precision Grip + rTMS and Sham rTMS (Controls)
n=5 Participants
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.
rTMS/Sham rTMS/Sham rTMS Over Control Brain Area
n=5 Participants
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.
Training + rTMS
n=4 Participants
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
Training + Sham rTMS
n=3 Participants
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
Total
n=32 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=5 Participants
5 Participants
n=7 Participants
5 Participants
n=5 Participants
5 Participants
n=4 Participants
5 Participants
n=21 Participants
4 Participants
n=10 Participants
3 Participants
n=115 Participants
32 Participants
n=6 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
Age, Continuous
44 years
n=5 Participants
48 years
n=7 Participants
53 years
n=5 Participants
51 years
n=4 Participants
43 years
n=21 Participants
45 years
n=10 Participants
41 years
n=115 Participants
45 years
n=6 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=10 Participants
0 Participants
n=115 Participants
8 Participants
n=6 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
3 Participants
n=7 Participants
2 Participants
n=5 Participants
4 Participants
n=4 Participants
4 Participants
n=21 Participants
3 Participants
n=10 Participants
3 Participants
n=115 Participants
24 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
4 Participants
n=7 Participants
4 Participants
n=5 Participants
1 Participants
n=4 Participants
4 Participants
n=21 Participants
3 Participants
n=10 Participants
2 Participants
n=115 Participants
21 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=10 Participants
1 Participants
n=115 Participants
8 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
3 Participants
n=6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
1 Participants
n=6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
2 Participants
n=6 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
3 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
3 Participants
n=21 Participants
2 Participants
n=10 Participants
2 Participants
n=115 Participants
14 Participants
n=6 Participants
Race (NIH/OMB)
White
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=10 Participants
0 Participants
n=115 Participants
4 Participants
n=6 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=10 Participants
1 Participants
n=115 Participants
8 Participants
n=6 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
3 Participants
n=6 Participants
Region of Enrollment
United States
5 Participants
n=5 Participants
5 Participants
n=7 Participants
5 Participants
n=5 Participants
5 Participants
n=4 Participants
5 Participants
n=21 Participants
4 Participants
n=10 Participants
3 Participants
n=115 Participants
32 Participants
n=6 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure
Wrist Flexion and Precision Grip + rTMS (SCI)
n=5 Participants
This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, 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. This information is from 5 SCI participants. The same 5 participants also participated in the Wrist flexion and precision grip + Sham rTMS.
Wrist Flexion and Precision Grip + Sham rTMS (SCI)
n=5 Participants
This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting \~2 hours separated by at least two days. Wrist flexion and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. This information is from 5 SCI participants. The same 5 participants also participated in the Wrist flexion and precision grip + rTMS.
Wrist Flexion and Precision Grip + rTMS (Control)
n=5 Participants
This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, 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. This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist flexion and precision grip + Sham rTMS.
Wrist Flexion and Precision Grip + Sham rTMS (Control)
n=5 Participants
This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting \~2 hours separated by at least two days. Wrist flexion and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist flexion and precision grip + rTMS.
Wrist Extension and Precision Grip + rTMS (SCI)
n=5 Participants
This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, 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. This information is from 5 SCI participants. The same 5 SCI participants also participated in the Wrist extension and precision grip + Sham rTMS.
Wrist Extension and Precision Grip + Sham rTMS (SCI)
n=5 Participants
This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting \~2 hours separated by at least two days. Wrist extension and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. This information is from 5 SCI participants. The same 5 SCI participants also participated in the Wrist extension and precision grip + rTMS.
Wrist Extension and Precision Grip + rTMS (Control)
n=5 Participants
This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, 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. This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist extension and precision grip + Sham rTMS.
Wrist Extension and Precision Grip + Sham rTMS (Control)
n=5 Participants
This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting \~2 hours separated by at least two days. Wrist extension and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist extension and precision grip + rTMS.
rTMS/Sham rTMS/Sham rTMS Over Control Brain Area
n=5 Participants
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. This information is from 5 SCI participants.
Training + rTMS
n=4 Participants
Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 sessions, and Post all training sessions.
Training + Sham rTMS
n=3 Participants
Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Sham or fake Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 sessions, and Post all training sessions.
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
0.43 millivolts (mV)
Standard Deviation 0.77
0.45 millivolts (mV)
Standard Deviation 0.81
0.65 millivolts (mV)
Standard Deviation 1.12
0.33 millivolts (mV)
Standard Deviation 0.92
0.44 millivolts (mV)
Standard Deviation 0.61
0.59 millivolts (mV)
Standard Deviation 0.98
0.52 millivolts (mV)
Standard Deviation 0.83
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
0.39 millivolts (mV)
Standard Deviation 0.88
0.47 millivolts (mV)
Standard Deviation 1.12
0.71 millivolts (mV)
Standard Deviation 1.08
0.37 millivolts (mV)
Standard Deviation 0.83
0.46 millivolts (mV)
Standard Deviation 0.72
0.66 millivolts (mV)
Standard Deviation 1.02
0.56 millivolts (mV)
Standard Deviation 1.06
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
0.41 millivolts (mV)
Standard Deviation 0.80
0.51 millivolts (mV)
Standard Deviation 0.52
0.68 millivolts (mV)
Standard Deviation 0.91
0.42 millivolts (mV)
Standard Deviation 1.17
0.45 millivolts (mV)
Standard Deviation 0.93
0.63 millivolts (mV)
Standard Deviation 1.07
0.53 millivolts (mV)
Standard Deviation 0.92
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
0.42 millivolts (mV)
Standard Deviation 0.65
0.53 millivolts (mV)
Standard Deviation 0.85
0.72 millivolts (mV)
Standard Deviation 1.15
0.45 millivolts (mV)
Standard Deviation 0.98
0.42 millivolts (mV)
Standard Deviation 1.02
0.65 millivolts (mV)
Standard Deviation 0.97
0.61 millivolts (mV)
Standard Deviation 0.82
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
0.45 millivolts (mV)
Standard Deviation 0.81
0.49 millivolts (mV)
Standard Deviation 1.26
0.66 millivolts (mV)
Standard Deviation 0.82
0.44 millivolts (mV)
Standard Deviation 0.67
0.61 millivolts (mV)
Standard Deviation 0.98
0.66 millivolts (mV)
Standard Deviation 1.03
0.57 millivolts (mV)
Standard Deviation 0.91
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
0.44 millivolts (mV)
Standard Deviation 0.79
0.51 millivolts (mV)
Standard Deviation 0.35
0.71 millivolts (mV)
Standard Deviation 1.13
0.41 millivolts (mV)
Standard Deviation 1.02
0.59 millivolts (mV)
Standard Deviation 1.03
0.71 millivolts (mV)
Standard Deviation 0.98
0.63 millivolts (mV)
Standard Deviation 0.70
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
0.43 millivolts (mV)
Standard Deviation 0.61
0.50 millivolts (mV)
Standard Deviation 0.81
0.73 millivolts (mV)
Standard Deviation 0.91
0.42 millivolts (mV)
Standard Deviation 0.91
0.63 millivolts (mV)
Standard Deviation 1.12
0.72 millivolts (mV)
Standard Deviation 1.04
0.61 millivolts (mV)
Standard Deviation 1.02
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
0.44 millivolts (mV)
Standard Deviation 0.71
0.55 millivolts (mV)
Standard Deviation 0.33
0.74 millivolts (mV)
Standard Deviation 0.78
0.46 millivolts (mV)
Standard Deviation 0.88
0.66 millivolts (mV)
Standard Deviation 0.98
0.74 millivolts (mV)
Standard Deviation 1.12
0.62 millivolts (mV)
Standard Deviation 0.87
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
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
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
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 0.70
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
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
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
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
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
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
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
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
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
0.61 millivolts (mV)
Standard Deviation 0.80
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
0.68 millivolts (mV)
Standard Deviation 0.74
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
0.69 millivolts (mV)
Standard Deviation 0.88

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Wrist Flexion and Precision Grip + rTMS (SCI)
n=5 Participants
This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, 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. This information is from 5 SCI participants. The same 5 participants also participated in the Wrist flexion and precision grip + Sham rTMS.
Wrist Flexion and Precision Grip + Sham rTMS (SCI)
This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting \~2 hours separated by at least two days. Wrist flexion and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. This information is from 5 SCI participants. The same 5 participants also participated in the Wrist flexion and precision grip + rTMS.
Wrist Flexion and Precision Grip + rTMS (Control)
This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, 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. This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist flexion and precision grip + Sham rTMS.
Wrist Flexion and Precision Grip + Sham rTMS (Control)
This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting \~2 hours separated by at least two days. Wrist flexion and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist flexion and precision grip + rTMS.
Wrist Extension and Precision Grip + rTMS (SCI)
This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, 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. This information is from 5 SCI participants. The same 5 SCI participants also participated in the Wrist extension and precision grip + Sham rTMS.
Wrist Extension and Precision Grip + Sham rTMS (SCI)
This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting \~2 hours separated by at least two days. Wrist extension and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. This information is from 5 SCI participants. The same 5 SCI participants also participated in the Wrist extension and precision grip + rTMS.
Wrist Extension and Precision Grip + rTMS (Control)
This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, 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. This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist extension and precision grip + Sham rTMS.
Wrist Extension and Precision Grip + Sham rTMS (Control)
This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting \~2 hours separated by at least two days. Wrist extension and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist extension and precision grip + rTMS.
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. This information is from 5 SCI participants.
Training + rTMS
Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 sessions, and Post all training sessions.
Training + Sham rTMS
Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Sham or fake Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 sessions, and Post all training sessions.
Electromyography (EMG)
Session 1: Before
0.138 Millivolts (mV)
Standard Deviation 0.239
Electromyography (EMG)
Session 1: After
0.191 Millivolts (mV)
Standard Deviation 0.323
Electromyography (EMG)
Session 2: Before
0.204 Millivolts (mV)
Standard Deviation 0.361
Electromyography (EMG)
Session 2: After
0.208 Millivolts (mV)
Standard Deviation 0.384
Electromyography (EMG)
Session 3: Before
0.221 Millivolts (mV)
Standard Deviation 0.329
Electromyography (EMG)
Session 3: After
0.231 Millivolts (mV)
Standard Deviation 0.352

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Wrist Flexion and Precision Grip + rTMS (SCI)
n=4 Participants
This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, 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. This information is from 5 SCI participants. The same 5 participants also participated in the Wrist flexion and precision grip + Sham rTMS.
Wrist Flexion and Precision Grip + Sham rTMS (SCI)
n=3 Participants
This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting \~2 hours separated by at least two days. Wrist flexion and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. This information is from 5 SCI participants. The same 5 participants also participated in the Wrist flexion and precision grip + rTMS.
Wrist Flexion and Precision Grip + rTMS (Control)
This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, 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. This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist flexion and precision grip + Sham rTMS.
Wrist Flexion and Precision Grip + Sham rTMS (Control)
This study arm is a crossover design. Participants will be randomized to either: Wrist flexion and precision grip + rTMS or Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting \~2 hours separated by at least two days. Wrist flexion and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist flexion and precision grip + rTMS.
Wrist Extension and Precision Grip + rTMS (SCI)
This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, 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. This information is from 5 SCI participants. The same 5 SCI participants also participated in the Wrist extension and precision grip + Sham rTMS.
Wrist Extension and Precision Grip + Sham rTMS (SCI)
This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting \~2 hours separated by at least two days. Wrist extension and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. This information is from 5 SCI participants. The same 5 SCI participants also participated in the Wrist extension and precision grip + rTMS.
Wrist Extension and Precision Grip + rTMS (Control)
This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, 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. This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist extension and precision grip + Sham rTMS.
Wrist Extension and Precision Grip + Sham rTMS (Control)
This study arm is a crossover design. Participants will be randomized to either: Wrist extension and precision grip + rTMS or Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits, one visit in each condition, each lasting \~2 hours separated by at least two days. Wrist extension and precision grip + Sham rTMS: Participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. A sham or fake magnetic stimulation to the brain (Sham rTMS) will be administered. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. This information is from 5 Control participants. The same 5 Control participants also participated in the Wrist extension and precision grip + rTMS.
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. This information is from 5 SCI participants.
Training + rTMS
Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 sessions, and Post all training sessions.
Training + Sham rTMS
Participants are asked to follow a target line on the computer as accurately as possible while performing precision grips. Sham or fake Magnetic stimulation will be given during. Participants are asked to complete 10 of these sessions. Participants will also be asked to complete measurements at Baseline, Post 5 sessions, and Post all training sessions.
The Jebsen Taylor Hand Function Test (JTT)
Baseline
74.1 Time (seconds)
Standard Deviation 21.6
88.6 Time (seconds)
Standard Deviation 19.6
The Jebsen Taylor Hand Function Test (JTT)
Post 5 training sessions
54.4 Time (seconds)
Standard Deviation 13.9
79.3 Time (seconds)
Standard Deviation 18.7
The Jebsen Taylor Hand Function Test (JTT)
Post all training sessions
44.8 Time (seconds)
Standard Deviation 15.2
84.8 Time (seconds)
Standard Deviation 14.2

Adverse Events

Wrist Flexion and Precision Grip + rTMS and Sham rTMS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Wrist Extension and Precision Grip + rTMS and Sham rTMS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

rTMS/Sham rTMS/Sham rTMS Over Control Brain Area

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Training + rTMS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Training + Sham rTMS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Audrey Wilson

Hines VA

Phone: 3122383637

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place