Trial Outcomes & Findings for Modulation of Spontaneous Cortical Activity by tDCS: BRAIN Initiative I (NCT NCT03672747)
NCT ID: NCT03672747
Last Updated: 2024-07-31
Results Overview
Do participants perform better in terms of accuracy following tDCS on behavioral measures of perceptual processing.
COMPLETED
NA
133 participants
During the 90 minutes following stimulation
2024-07-31
Participant Flow
Note that 133 participants were enrolled using a cross-over design and randomized into one of six tracks. There was at least a 7 day washout between each of the three visits and this was the same across the six tracks.
Participant milestones
| Measure |
Anodal Stimulation, Then Cathodal Stimulation, Then Sham
Participants received 20 minutes of anodal stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of cathodal stimulation using HD-tDCS. At least seven days later, they received 20 minutes of sham stimulation using HD-tDCS.
|
Anodal Stimulation, Then Sham Stimulation, Then Cathodal Stimulation
Participants received 20 minutes of anodal stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of sham stimulation using HD-tDCS. At least seven days later, they received 20 minutes of cathodal stimulation using HD-tDCS.
|
Cathodal Stimulation, Then Anodal Stimulation, Then Sham
Participants received 20 minutes of cathodal stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of anodal stimulation using HD-tDCS. At least seven days later, they received 20 minutes of sham stimulation using HD-tDCS.
|
Cathodal Stimulation, Then Sham, Then Anodal Stimulation
Participants received 20 minutes of cathodal stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of sham stimulation using HD-tDCS. At least seven days later, they received 20 minutes of anodal stimulation using HD-tDCS.
|
Sham Stimulation, Then Anodal Stimulation, Then Cathodal Stimulation
Participants received 20 minutes of sham stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of anodal stimulation using HD-tDCS. At least seven days later, they received 20 minutes of cathodal stimulation using HD-tDCS.
|
Sham Stimulation, Then Cathodal Stimulation, Then Anodal Stimulation
Participants received 20 minutes of sham stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of cathodal stimulation using HD-tDCS. At least seven days later, they received 20 minutes of anodal stimulation using HD-tDCS.
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|---|---|---|---|---|---|---|
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Overall Study
STARTED
|
22
|
22
|
22
|
23
|
22
|
22
|
|
Overall Study
COMPLETED
|
21
|
21
|
20
|
21
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
Anodal Stimulation, Then Cathodal Stimulation, Then Sham
Participants received 20 minutes of anodal stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of cathodal stimulation using HD-tDCS. At least seven days later, they received 20 minutes of sham stimulation using HD-tDCS.
|
Anodal Stimulation, Then Sham Stimulation, Then Cathodal Stimulation
Participants received 20 minutes of anodal stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of sham stimulation using HD-tDCS. At least seven days later, they received 20 minutes of cathodal stimulation using HD-tDCS.
|
Cathodal Stimulation, Then Anodal Stimulation, Then Sham
Participants received 20 minutes of cathodal stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of anodal stimulation using HD-tDCS. At least seven days later, they received 20 minutes of sham stimulation using HD-tDCS.
|
Cathodal Stimulation, Then Sham, Then Anodal Stimulation
Participants received 20 minutes of cathodal stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of sham stimulation using HD-tDCS. At least seven days later, they received 20 minutes of anodal stimulation using HD-tDCS.
|
Sham Stimulation, Then Anodal Stimulation, Then Cathodal Stimulation
Participants received 20 minutes of sham stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of anodal stimulation using HD-tDCS. At least seven days later, they received 20 minutes of cathodal stimulation using HD-tDCS.
|
Sham Stimulation, Then Cathodal Stimulation, Then Anodal Stimulation
Participants received 20 minutes of sham stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of cathodal stimulation using HD-tDCS. At least seven days later, they received 20 minutes of anodal stimulation using HD-tDCS.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
2
|
2
|
1
|
Baseline Characteristics
Modulation of Spontaneous Cortical Activity by tDCS: BRAIN Initiative I
Baseline characteristics by cohort
| Measure |
All Study Participants
n=124 Participants
All participants received all interventions.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
103 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
|
Age, Continuous
|
44 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
124 participants
n=5 Participants
|
|
Mental health questionnaire
|
124 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the 90 minutes following stimulationPopulation: 124 participants completed all three conditions (anodal, cathodal, sham) and have evaluable data.
Do participants perform better in terms of accuracy following tDCS on behavioral measures of perceptual processing.
Outcome measures
| Measure |
Anodal Stimulation
n=124 Participants
Participants will receive 20 minutes of anodal stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
Cathodal Stimulation
n=124 Participants
Participants will receive 20 minutes of cathodal stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
Sham Stimulation (Placebo)
n=124 Participants
Participants will receive 20 minutes of sham stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
|---|---|---|---|
|
Behavioral Performance (Accuracy) on Cognitive Tests of Perceptual Processing
|
97 percent correct
Standard Deviation 1.26
|
98 percent correct
Standard Deviation 1.05
|
98 percent correct
Standard Deviation .94
|
PRIMARY outcome
Timeframe: During the 90 minutes following stimulationPopulation: 124 participants completed all three conditions (anodal, cathodal, sham) and have evaluable data.
Do participants perform better in terms of reaction time following tDCS on behavioral measures of perceptual processing.
Outcome measures
| Measure |
Anodal Stimulation
n=124 Participants
Participants will receive 20 minutes of anodal stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
Cathodal Stimulation
n=124 Participants
Participants will receive 20 minutes of cathodal stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
Sham Stimulation (Placebo)
n=124 Participants
Participants will receive 20 minutes of sham stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
|---|---|---|---|
|
Behavioral Performance (Reaction Time) on Cognitive Tests of Perceptual Processing
|
713 milliseconds
Standard Deviation 67
|
708 milliseconds
Standard Deviation 58
|
724 milliseconds
Standard Deviation 52
|
SECONDARY outcome
Timeframe: During the 90 minutes following stimulationPopulation: 124 participants completed all three conditions (anodal, cathodal, sham) and have evaluable data.
Does spontaneous alpha (9-13 Hz) power, as measured by MEG, get stronger following tDCS. Spontaneous activity refers to the level of background neural activity and is typically divided into frequency bands (e.g., alpha, gamma) that reflect the number of cycles per second. The outcome measure unit is nano-amperes square (nA\^2) since source-resolved MEG measures reflect electric current strength and not voltage units as in electroencephalography (EEG). The square is necessary since we examined power, which is the square of amplitude in the frequency domain. The unit is also commonly expressed as nAm\^2 since the strength of the electric current is over a defined length.
Outcome measures
| Measure |
Anodal Stimulation
n=124 Participants
Participants will receive 20 minutes of anodal stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
Cathodal Stimulation
n=124 Participants
Participants will receive 20 minutes of cathodal stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
Sham Stimulation (Placebo)
n=124 Participants
Participants will receive 20 minutes of sham stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
|---|---|---|---|
|
The Power of Spontaneous Alpha Activity as Quantified by MEG Imaging
|
23.26 nano-amperes square (nA^2)
Standard Error 3.06
|
15.88 nano-amperes square (nA^2)
Standard Error 2.18
|
17.02 nano-amperes square (nA^2)
Standard Error 2.46
|
SECONDARY outcome
Timeframe: During the 90 minutes following stimulationPopulation: 124 participants completed all three conditions (anodal, cathodal, sham) and have evaluable data.
Does oscillatory alpha neural activity, as measured by MEG, get stronger following tDCS. Oscillatory activity refers band-limited increases or decreases in the power of neural activity, relative to baseline, in response to a stimulus.
Outcome measures
| Measure |
Anodal Stimulation
n=124 Participants
Participants will receive 20 minutes of anodal stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
Cathodal Stimulation
n=124 Participants
Participants will receive 20 minutes of cathodal stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
Sham Stimulation (Placebo)
n=124 Participants
Participants will receive 20 minutes of sham stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
|---|---|---|---|
|
The Power of Oscillatory Alpha Activity as Quantified by MEG Imaging
|
-27.34 percent increase/decrease from baseline
Standard Error 3.18
|
-26.10 percent increase/decrease from baseline
Standard Error 3.03
|
-30.88 percent increase/decrease from baseline
Standard Error 5.11
|
SECONDARY outcome
Timeframe: During the 90 minutes following stimulationPopulation: 124 participants completed all three conditions (anodal, cathodal, sham) and have evaluable data.
Does spontaneous gamma (45-80 Hz) power, as measured by MEG, get stronger following tDCS. Spontaneous activity refers to the level of background neural activity and is typically divided into frequency bands (e.g., alpha, gamma) that reflect the number of cycles per second. The outcome measure unit is nano-amperes square (nA\^2) since source-resolved MEG measures reflect electric current strength and not voltage units as in electroencephalography (EEG). The square is necessary since we examined power, which is the square of amplitude in the frequency domain. The unit is also commonly expressed as nAm\^2 since the strength of the electric current is over a defined length.
Outcome measures
| Measure |
Anodal Stimulation
n=124 Participants
Participants will receive 20 minutes of anodal stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
Cathodal Stimulation
n=124 Participants
Participants will receive 20 minutes of cathodal stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
Sham Stimulation (Placebo)
n=124 Participants
Participants will receive 20 minutes of sham stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
|---|---|---|---|
|
The Power of Spontaneous Gamma Activity as Quantified by MEG Imaging
|
3.46 nano-amperes square (nA^2)
Standard Error 1.74
|
3.30 nano-amperes square (nA^2)
Standard Error 1.89
|
2.43 nano-amperes square (nA^2)
Standard Error 1.55
|
SECONDARY outcome
Timeframe: During the 90 minutes following stimulationPopulation: 124 participants completed all three conditions (anodal, cathodal, sham) and have evaluable data.
Does oscillatory gamma neural activity, as measured by MEG, get stronger following tDCS. Oscillatory activity refers band-limited increases or decreases in the power of neural activity, relative to baseline, in response to a stimulus.
Outcome measures
| Measure |
Anodal Stimulation
n=124 Participants
Participants will receive 20 minutes of anodal stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
Cathodal Stimulation
n=124 Participants
Participants will receive 20 minutes of cathodal stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
Sham Stimulation (Placebo)
n=124 Participants
Participants will receive 20 minutes of sham stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration
|
|---|---|---|---|
|
The Power of Oscillatory Gamma Activity as Quantified by MEG Imaging
|
10.78 percent increase/decrease from baseline
Standard Error 2.74
|
6.35 percent increase/decrease from baseline
Standard Error 1.98
|
6.28 percent increase/decrease from baseline
Standard Error 1.87
|
Adverse Events
Anodal Stimulation
Cathodal Stimulation
Sham Stimulation (Placebo)
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