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.
COMPLETED
NA
42 participants
Post rTMS, Sham rTMS, and Sham rTMS over control brain for all sessions at minute 0, 10, 30, and 60
2021-06-11
Participant Flow
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
| 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
| 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 60Population: 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
| 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
| 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
| 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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The Jebsen Taylor Hand Function Test (JTT)
Baseline
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74.1 Time (seconds)
Standard Deviation 21.6
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88.6 Time (seconds)
Standard Deviation 19.6
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The Jebsen Taylor Hand Function Test (JTT)
Post 5 training sessions
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54.4 Time (seconds)
Standard Deviation 13.9
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79.3 Time (seconds)
Standard Deviation 18.7
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The Jebsen Taylor Hand Function Test (JTT)
Post all training sessions
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44.8 Time (seconds)
Standard Deviation 15.2
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84.8 Time (seconds)
Standard Deviation 14.2
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Adverse Events
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
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place