Trial Outcomes & Findings for Effect of Cross Frequency tACS on Cognitive Control (NCT NCT03800030)

NCT ID: NCT03800030

Last Updated: 2020-05-18

Results Overview

For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The reaction time difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

through study completion, an average of 3 weeks

Results posted on

2020-05-18

Participant Flow

Participant milestones

Participant milestones
Measure
Theta-gamma, Delta-beta, Sham
Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task. Sequence: Theta-gamma tACS, then Delta-beta tACS, then Sham tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus
Theta-gamma, Sham, Delta-beta
Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task. Sequence: Theta-gamma tACS, then Sham tACS, then Delta-beta tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus
Delta-beta, Theta-gamma, Sham tACS
Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task. Sequence: Delta-beta tACS, then Theta-gamma tACS, then Sham tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus
Delta-beta, Sham, Theta-gamma tACS
Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task. Sequence: Delta-beta tACS, then Sham tACS, then Theta-gamma tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus
Sham, Delta-beta, Theta-gamma tACS
Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task. Sequence: Sham tACS, then Delta-beta tACS, then Theta-gamma tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus
Sham, Theta-gamma, Delta-beta tACS
Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task. Sequence: Sham tACS, then Theta-gamma tACS, then Delta-beta tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus
Baseline
STARTED
4
4
4
6
4
4
Baseline
COMPLETED
4
4
4
6
4
4
Baseline
NOT COMPLETED
0
0
0
0
0
0
Pre-Randomization Period (1 Week)
STARTED
4
4
4
6
4
4
Pre-Randomization Period (1 Week)
COMPLETED
4
4
4
6
4
4
Pre-Randomization Period (1 Week)
NOT COMPLETED
0
0
0
0
0
0
First Intervention
STARTED
4
4
4
6
4
4
First Intervention
COMPLETED
4
4
4
6
4
4
First Intervention
NOT COMPLETED
0
0
0
0
0
0
First Washout (1 Week)
STARTED
4
4
4
6
4
4
First Washout (1 Week)
COMPLETED
4
4
4
6
4
4
First Washout (1 Week)
NOT COMPLETED
0
0
0
0
0
0
Second Intervention
STARTED
4
4
4
6
4
4
Second Intervention
COMPLETED
4
4
4
5
4
4
Second Intervention
NOT COMPLETED
0
0
0
1
0
0
Second Washout (1 Week)
STARTED
4
4
4
5
4
4
Second Washout (1 Week)
COMPLETED
4
4
4
4
4
4
Second Washout (1 Week)
NOT COMPLETED
0
0
0
1
0
0
Third Intervention
STARTED
4
4
4
4
4
4
Third Intervention
COMPLETED
4
4
4
4
4
4
Third Intervention
NOT COMPLETED
0
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=26 Participants
Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Age, Continuous
19.654 years
STANDARD_DEVIATION 1.4951 • n=26 Participants
Sex: Female, Male
Female
21 Participants
n=26 Participants
Sex: Female, Male
Male
5 Participants
n=26 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=26 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants
n=26 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
n=26 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=26 Participants
Race (NIH/OMB)
Asian
5 Participants
n=26 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=26 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=26 Participants
Race (NIH/OMB)
White
15 Participants
n=26 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=26 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
n=26 Participants
Region of Enrollment
United States
26 Participants
n=26 Participants
Baseline Reaction Time Difference for Abstraction
0.1637 seconds
STANDARD_DEVIATION 0.1012 • n=23 Participants • One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis.
Baseline Reaction Time Difference for Set-Size
0.2272 seconds
STANDARD_DEVIATION 0.0844 • n=23 Participants • One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis.
Baseline Percent Correct Difference for Abstraction
0.0679 percent correct
STANDARD_DEVIATION 4.9692 • n=23 Participants • One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis.
Baseline Percent Correct Difference for Set-Size
-1.0190 percent correct
STANDARD_DEVIATION 4.4569 • n=23 Participants • One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis.
Baseline Delta Phase to Beta Amplitude Coupling
0.0406 Z-score
STANDARD_DEVIATION 0.3232 • n=23 Participants • One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis.
Theta Phase to Gamma Amplitude Coupling Strength
0.0739 Z-score
STANDARD_DEVIATION 0.4214 • n=23 Participants • One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis.

PRIMARY outcome

Timeframe: through study completion, an average of 3 weeks

Population: One participant excluded from behavioral analysis because they did not follow task instructions.

For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The reaction time difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis.

Outcome measures

Outcome measures
Measure
Theta-gamma tACS
n=23 Participants
Every participant will receive Theta-gamma tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Delta-beta tACS
n=23 Participants
Every participant will receive Delta-beta tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Sham tACS
n=23 Participants
Every participant will receive Sham tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Reaction Time for Trials With High Abstraction Relative to Low Abstraction
0.1247 seconds
Standard Deviation 0.0800
0.1444 seconds
Standard Deviation 0.0832
0.1022 seconds
Standard Deviation 0.0947

PRIMARY outcome

Timeframe: through study completion, an average of 3 weeks

Population: One participant excluded from behavioral analysis because they did not follow task instructions.

The reaction time difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis.

Outcome measures

Outcome measures
Measure
Theta-gamma tACS
n=23 Participants
Every participant will receive Theta-gamma tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Delta-beta tACS
n=23 Participants
Every participant will receive Delta-beta tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Sham tACS
n=23 Participants
Every participant will receive Sham tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Reaction Time for Trials With High Set-size Relative to Low Set-size
0.1905 seconds
Standard Deviation 0.0676
0.1853 seconds
Standard Deviation 0.1057
0.1888 seconds
Standard Deviation 0.0760

PRIMARY outcome

Timeframe: through study completion, an average of 3 weeks

Population: One participant excluded from coupling analysis because they did not follow task instructions.

Delta-beta tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between delta phase and beta amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the beta amplitude time series relative to the delta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution.

Outcome measures

Outcome measures
Measure
Theta-gamma tACS
n=23 Participants
Every participant will receive Theta-gamma tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Delta-beta tACS
n=23 Participants
Every participant will receive Delta-beta tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Sham tACS
n=23 Participants
Every participant will receive Sham tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Delta Phase to Beta Amplitude Coupling Strength
-0.0873 Z-score
Standard Deviation 0.3035
0.1123 Z-score
Standard Deviation 0.2939
-0.1250 Z-score
Standard Deviation 0.2651

PRIMARY outcome

Timeframe: through study completion, an average of 3 weeks

Population: One participant was excluded from coupling analysis because they did not follow task instructions.

Theta-gamma tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between theta phase and gamma amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the gamma amplitude time series relative to the theta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution.

Outcome measures

Outcome measures
Measure
Theta-gamma tACS
n=23 Participants
Every participant will receive Theta-gamma tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Delta-beta tACS
n=23 Participants
Every participant will receive Delta-beta tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Sham tACS
n=23 Participants
Every participant will receive Sham tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Theta Phase to Gamma Amplitude Coupling Strength
0.1615 Z-score
Standard Deviation 0.3563
0.0706 Z-score
Standard Deviation 0.3496
0.0577 Z-score
Standard Deviation 0.4043

PRIMARY outcome

Timeframe: through study completion, an average of 3 weeks

Population: One participant excluded from behavioral analysis because they did not follow task instructions.

For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The accuracy difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis.

Outcome measures

Outcome measures
Measure
Theta-gamma tACS
n=23 Participants
Every participant will receive Theta-gamma tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Delta-beta tACS
n=23 Participants
Every participant will receive Delta-beta tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Sham tACS
n=23 Participants
Every participant will receive Sham tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Percent Correct for Trials With High Abstraction Relative to Low Abstraction
0.5661 percent correct
Standard Deviation 3.1678
-0.2944 percent correct
Standard Deviation 7.4718
0.7246 percent correct
Standard Deviation 6.6416

PRIMARY outcome

Timeframe: through study completion, an average of 3 weeks

Population: One participant excluded from behavioral analysis because they did not follow task instructions.

The accuracy difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis.

Outcome measures

Outcome measures
Measure
Theta-gamma tACS
n=23 Participants
Every participant will receive Theta-gamma tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Delta-beta tACS
n=23 Participants
Every participant will receive Delta-beta tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Sham tACS
n=23 Participants
Every participant will receive Sham tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Percent Correct for Trials With High Set-size Relative to Low Set-size
-2.2871 percent correct
Standard Deviation 2.9242
-4.3252 percent correct
Standard Deviation 6.8997
-4.1667 percent correct
Standard Deviation 4.3264

Adverse Events

Theta-gamma tACS

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Delta-beta tACS

Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths

Sham tACS

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Theta-gamma tACS
n=24 participants at risk
Every participant will receive Theta-gamma tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Delta-beta tACS
n=26 participants at risk
Every participant will receive Delta-beta tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Sham tACS
n=26 participants at risk
Every participant will receive Sham tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus
Investigations
Tingling
37.5%
9/24 • Number of events 9 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
38.5%
10/26 • Number of events 10 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
26.9%
7/26 • Number of events 7 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
Investigations
Flickering lights
8.3%
2/24 • Number of events 2 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
15.4%
4/26 • Number of events 4 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
7.7%
2/26 • Number of events 2 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
Investigations
Itching
8.3%
2/24 • Number of events 2 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
19.2%
5/26 • Number of events 5 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
15.4%
4/26 • Number of events 4 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
Investigations
Burning sensation
12.5%
3/24 • Number of events 3 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
11.5%
3/26 • Number of events 3 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
19.2%
5/26 • Number of events 5 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
Investigations
Scalp pain
12.5%
3/24 • Number of events 3 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
11.5%
3/26 • Number of events 3 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
7.7%
2/26 • Number of events 2 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
Investigations
Neck pain
4.2%
1/24 • Number of events 1 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
3.8%
1/26 • Number of events 1 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
0.00%
0/26 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
Investigations
Dizziness
0.00%
0/24 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
11.5%
3/26 • Number of events 3 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
0.00%
0/26 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
Investigations
Local redness
4.2%
1/24 • Number of events 1 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
3.8%
1/26 • Number of events 1 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
0.00%
0/26 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
Investigations
Sleepiness
4.2%
1/24 • Number of events 1 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
0.00%
0/26 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
0.00%
0/26 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
Investigations
Headache
12.5%
3/24 • Number of events 3 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
3.8%
1/26 • Number of events 1 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
11.5%
3/26 • Number of events 3 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
Investigations
Ringing noise
4.2%
1/24 • Number of events 1 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
0.00%
0/26 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
0.00%
0/26 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
Investigations
Blurred vision
0.00%
0/24 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
0.00%
0/26 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.
3.8%
1/26 • Number of events 1 • Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention.

Additional Information

Justin Riddle, PhD

University of North Carolina at Chapel Hill

Phone: 6617131602

Results disclosure agreements

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