Trial Outcomes & Findings for Modulation of Motor Cortex Excitability by TMS and tDCS (MAGS1) (NCT NCT03481309)
NCT ID: NCT03481309
Last Updated: 2021-03-04
Results Overview
The investigators will record motor-evoked potentials and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
right before and after 2mA tDCS stimulation for 10 minutes at each session
Results posted on
2021-03-04
Participant Flow
Participant milestones
| Measure |
Anode -> Cathode -> Sham
During 3 study visits, participants will receive anodal tDCS first, then cathodal tDCS, then sham tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Anode -> Sham -> Cathode
During 3 study visits, participants will receive anodal tDCS first, then sham tDCS, then cathodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Cathode -> Anode -> Sham
During 3 study visits, participants will receive cathodal tDCS first, then anodal tDCS, then sham tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Cathode -> Sham -> Anode
During 3 study visits, participants will receive cathodal tDCS first, then sham tDCS, then anodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Sham -> Anode -> Cathode
During 3 study visits, participants will receive sham tDCS first, then anodal tDCS, then cathodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Sham -> Cathode -> Anode
During 3 study visits, participants will receive sham tDCS first, then cathodal tDCS, then anodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
|---|---|---|---|---|---|---|
|
First Intervention (1 Day)
STARTED
|
4
|
3
|
3
|
3
|
3
|
3
|
|
First Intervention (1 Day)
COMPLETED
|
4
|
3
|
3
|
3
|
3
|
3
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout (at Least 3 Days)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout (at Least 3 Days)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout (at Least 3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Second Intervention (1 Day)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (1 Day)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Third Intervention (1 Day)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Third Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Anode -> Cathode -> Sham
During 3 study visits, participants will receive anodal tDCS first, then cathodal tDCS, then sham tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Anode -> Sham -> Cathode
During 3 study visits, participants will receive anodal tDCS first, then sham tDCS, then cathodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Cathode -> Anode -> Sham
During 3 study visits, participants will receive cathodal tDCS first, then anodal tDCS, then sham tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Cathode -> Sham -> Anode
During 3 study visits, participants will receive cathodal tDCS first, then sham tDCS, then anodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Sham -> Anode -> Cathode
During 3 study visits, participants will receive sham tDCS first, then anodal tDCS, then cathodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Sham -> Cathode -> Anode
During 3 study visits, participants will receive sham tDCS first, then cathodal tDCS, then anodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
|---|---|---|---|---|---|---|
|
Washout (at Least 3 Days)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Modulation of Motor Cortex Excitability by TMS and tDCS (MAGS1)
Baseline characteristics by cohort
| Measure |
Anode -> Cathode -> Sham
n=4 Participants
During 3 study visits, participants will receive anodal tDCS first, then cathodal tDCS, then sham tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Anode -> Sham -> Cathode
n=3 Participants
During 3 study visits, participants will receive anodal tDCS first, then sham tDCS, then cathodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Cathode -> Anode -> Sham
n=3 Participants
During 3 study visits, participants will receive cathodal tDCS first, then anodal tDCS, then sham tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Cathode -> Sham -> Anode
n=3 Participants
During 3 study visits, participants will receive cathodal tDCS first, then sham tDCS, then anodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Sham -> Anode -> Cathode
n=3 Participants
During 3 study visits, participants will receive sham tDCS first, then anodal tDCS, then cathodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Sham -> Cathode -> Anode
n=3 Participants
During 3 study visits, participants will receive sham tDCS first, then cathodal tDCS, then anodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
|
Total
n=19 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
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
19 Participants
n=115 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
|
|
Age, Continuous
|
28.75 years
STANDARD_DEVIATION 6.68 • n=5 Participants
|
25.33 years
STANDARD_DEVIATION 6.94 • n=7 Participants
|
22.33 years
STANDARD_DEVIATION 1.24 • n=5 Participants
|
20.66 years
STANDARD_DEVIATION 0.47 • n=4 Participants
|
22 years
STANDARD_DEVIATION 4.24 • n=21 Participants
|
25.33 years
STANDARD_DEVIATION 6.12 • n=10 Participants
|
24.31 years
STANDARD_DEVIATION 5.84 • n=115 Participants
|
|
Sex: Female, Male
Female
|
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
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
19 Participants
n=115 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
3 Participants
n=115 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: right before and after 2mA tDCS stimulation for 10 minutes at each sessionPopulation: One participant signed the consent form but data for this participant was not recorded.
The investigators will record motor-evoked potentials and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes.
Outcome measures
| Measure |
Anodal tDCS
n=18 Participants
Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This anodal tDCS on the left motor cortex will be stimulated with 2mA for 10 minutes.
anodal tDCS: The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex.
|
Cathodal tDCS
n=18 Participants
Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This cathodal tDCS on the left motor cortex will be stimulated with -2mA for 10 minutes.
cathodal tDCS: The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex.
|
Sham tDCS
n=18 Participants
Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). Sham stimulation with 2mA for 40 seconds will be applied.
sham tDCS: The participant will receive sham tDCS with 2 mA for 40 seconds on the left motor cortex which mimics the skin sensations as active tDCS interventions.
|
|---|---|---|---|
|
Changes in Motor-evoked Potentials Ratios
|
1.32 Ratio (unit: uV)
Standard Error 0.09
|
0.73 Ratio (unit: uV)
Standard Error 0.07
|
1.03 Ratio (unit: uV)
Standard Error 0.05
|
PRIMARY outcome
Timeframe: right before and after 2mA tDCS stimulation for 10 minutes at each sessionPopulation: One participant signed the consent form but data for this participant was not recorded.
The investigators will record TMS-evoked potentials using EEG and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes.
Outcome measures
| Measure |
Anodal tDCS
n=18 Participants
Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This anodal tDCS on the left motor cortex will be stimulated with 2mA for 10 minutes.
anodal tDCS: The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex.
|
Cathodal tDCS
n=18 Participants
Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This cathodal tDCS on the left motor cortex will be stimulated with -2mA for 10 minutes.
cathodal tDCS: The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex.
|
Sham tDCS
n=18 Participants
Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). Sham stimulation with 2mA for 40 seconds will be applied.
sham tDCS: The participant will receive sham tDCS with 2 mA for 40 seconds on the left motor cortex which mimics the skin sensations as active tDCS interventions.
|
|---|---|---|---|
|
Changes in TMS-evoked Potentials Ratios
|
1.5 Ratio (unit: uV)
Standard Deviation 0.5
|
0.8 Ratio (unit: uV)
Standard Deviation 0.4
|
1.1 Ratio (unit: uV)
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 4 minutes recordings before and after each 2mA tDCS stimulation for 10 minutes at each sessionPopulation: One participant signed the consent form but data for this participant was not recorded.
The investigators will record participants' resting state for 4 minutes using EEG (2 minutes for eyes-closed and 2 minutes for eyes-open)
Outcome measures
| Measure |
Anodal tDCS
n=18 Participants
Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This anodal tDCS on the left motor cortex will be stimulated with 2mA for 10 minutes.
anodal tDCS: The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex.
|
Cathodal tDCS
n=18 Participants
Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This cathodal tDCS on the left motor cortex will be stimulated with -2mA for 10 minutes.
cathodal tDCS: The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex.
|
Sham tDCS
n=18 Participants
Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). Sham stimulation with 2mA for 40 seconds will be applied.
sham tDCS: The participant will receive sham tDCS with 2 mA for 40 seconds on the left motor cortex which mimics the skin sensations as active tDCS interventions.
|
|---|---|---|---|
|
Changes in Resting-state EEG Dynamics Ratios
|
1.2 Ratio (unit: uV)
Standard Deviation 0.7
|
0.8 Ratio (unit: uV)
Standard Deviation 0.3
|
1.1 Ratio (unit: uV)
Standard Deviation 0.5
|
Adverse Events
Anodal tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cathodal tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tDCS
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
Dr. Sangtae Ahn
University of North Carolina at Chapel Hill
Phone: 9195233127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place