Trial Outcomes & Findings for Metaplasticity Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change (NCT NCT03304262)
NCT ID: NCT03304262
Last Updated: 2023-08-25
Results Overview
Percent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes
Results posted on
2023-08-25
Participant Flow
This was a crossover design, in which each participant came in three times and was randomly assigned to each intervention with a wash-out period in between.
Participant milestones
| Measure |
Cathodal tDCS + rTMS Then Anodal tDCS + rTMS Then Sham tDCS + rTMS
Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2.
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
|
Anodal tDCS + rTMS Then Sham tDCS + rTMS Then Cathodal tDCS + rTMS
Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2.
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
|
Sham tDCS + rTMS Then Cathodal tDCS + rTMS Then Anodal tDCS + rTMS
Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2.
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
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|---|---|---|---|
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Overall Study
STARTED
|
4
|
5
|
4
|
|
Overall Study
COMPLETED
|
4
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metaplasticity Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change
Baseline characteristics by cohort
| Measure |
Cathodal tDCS + rTMS Then Anodal tDCS + rTMS Then Sham tDCS + rTMS
n=4 Participants
Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2.
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
|
Anodal tDCS + rTMS Then Sham tDCS + rTMS Then Cathodal tDCS + rTMS
n=5 Participants
Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2.
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
|
Sham tDCS + rTMS Then Cathodal tDCS + rTMS Then Anodal tDCS + rTMS
n=4 Participants
Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2.
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
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Age, Continuous
|
35.54 years
n=5 Participants
|
35.54 years
n=7 Participants
|
35.54 years
n=5 Participants
|
35.54 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: assessed and reported throughout study completion pre- and post- intervention approximately 30 minutesPercent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand
Outcome measures
| Measure |
Cathodal tDCS + rTMS
n=13 Participants
Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
|
Anodal tDCS + rTMS
n=13 Participants
Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
|
Sham tDCS + rTMS
n=13 Participants
Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
|
|---|---|---|---|
|
Percent Change in MEP Amplitude
|
1.19 Percent Change
Interval 0.43 to 5.65
|
1.06 Percent Change
Interval 0.33 to 2.03
|
1.38 Percent Change
Interval 0.19 to 2.82
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SECONDARY outcome
Timeframe: tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)Change in length of CSP
Outcome measures
| Measure |
Cathodal tDCS + rTMS
n=13 Participants
Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
|
Anodal tDCS + rTMS
n=13 Participants
Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
|
Sham tDCS + rTMS
n=13 Participants
Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
|
|---|---|---|---|
|
Cortical Silent Period
|
1.02 Percent change
Interval 0.88 to 1.23
|
1.01 Percent change
Interval 0.88 to 1.13
|
0.99 Percent change
Interval 0.88 to 1.08
|
SECONDARY outcome
Timeframe: The final outcome will be percent change in the reaction time from pre- to post- intervention.Participants will perform a simple reaction time task. This will be measured in seconds of response after a stimulus. The final outcome will be percent change in the reaction time from pre- to post- intervention.
Outcome measures
| Measure |
Cathodal tDCS + rTMS
n=13 Participants
Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
|
Anodal tDCS + rTMS
n=13 Participants
Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
|
Sham tDCS + rTMS
n=13 Participants
Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
|
|---|---|---|---|
|
Simple Reaction Time
|
1.01 Percent change
Interval 0.94 to 1.15
|
1.02 Percent change
Interval 0.91 to 1.19
|
1.02 Percent change
Interval 0.9 to 1.16
|
Adverse Events
Cathodal tDCS + rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anodal tDCS + rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tDCS + 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place