Trial Outcomes & Findings for Effects of Gamma-tACS on Memory and Sleep (NCT NCT05907707)

NCT ID: NCT05907707

Last Updated: 2025-04-02

Results Overview

To establish acceptability of tACS combined with cognitive testing in healthy elderly participants and will be considered acceptable if at least \>/= 80% of participants tolerate the procedure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Baseline (Day 1)

Results posted on

2025-04-02

Participant Flow

Participant milestones

Participant milestones
Measure
First Gamma (40Hz) Stimulation, Then Active Control (21Hz) Stimulation
After collecting sleep EEG at home for one night to acclimate to the data collection during sleep, participants first receive gamma (40Hz) tACS on Day 1 followed by a 5-9 day washout. Participants then receive active control (21Hz) stimulation. Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration). Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration). EEG headband: At-home, ambulatory, single-channel EEG headband which records brain activity during sleep Actigraphy wristband: At-home, ambulatory, wrist-worn accelerometer which records levels of motor activity during the whole day
First Active Control (21 Hz) Stimulation, Then Gamma (40 Hz) Stimulation
After collecting sleep EEG at home for one night to acclimate to the data collection during sleep, participants first receive active control (21Hz) tACS on Day 1 followed by a 5-9 day washout. Participants then receive gamma (40Hz) stimulation. Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration). Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration). EEG headband: At-home, ambulatory, single-channel EEG headband which records brain activity during sleep Actigraphy wristband: At-home, ambulatory, wrist-worn accelerometer which records levels of motor activity during the whole day
First Intervention
STARTED
5
6
First Intervention
COMPLETED
5
6
First Intervention
NOT COMPLETED
0
0
Washout (9 Days)
STARTED
5
6
Washout (9 Days)
COMPLETED
5
6
Washout (9 Days)
NOT COMPLETED
0
0
Second Intervention
STARTED
5
5
Second Intervention
COMPLETED
5
5
Second Intervention
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Gamma-tACS on Memory and Sleep

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=11 Participants
Participants who received transcranial alternating current stimulation: tACS.
Age, Customized
>50 Years of Age
11 Participants
n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 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
0 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
0 Participants
n=5 Participants
Race (NIH/OMB)
White
11 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
11 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: One participant was not exposed to 40 Hz due to their time constraints.

To establish acceptability of tACS combined with cognitive testing in healthy elderly participants and will be considered acceptable if at least \>/= 80% of participants tolerate the procedure.

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=10 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=10 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Percent of Participants Tolerating Cognitive Testing During tACS
100 percentage of participants
100 percentage of participants

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: One participant was not exposed to 40 Hz due to their time constraints.

Participants will memorize 15 words ("Rey Auditory Verbal Learning Test") during gamma-tACS or control-tACS. They will be required to recall the words on the same day. The number of correctly remembered words will be recorded.

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=10 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=10 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Verbal Memory at Day 1
7.7 Number of words recalled
Standard Deviation 1.7
6.9 Number of words recalled
Standard Deviation 2.4

PRIMARY outcome

Timeframe: Follow-Up (Day 2)

Population: One participant was not exposed to 40 Hz due to their time constraints.

Participants will memorize 15 words ("Rey Auditory Verbal Learning Test") during gamma-tACS or control-tACS. They will be required to recall the words on the day after. The number of correctly remembered words will be recorded.

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=10 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=10 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Verbal Memory at Day 2
5.7 Number of words recalled
Standard Deviation 1.9
5.5 Number of words recalled
Standard Deviation 2.5

PRIMARY outcome

Timeframe: Follow-Up (Day 5)

Population: One participant was not exposed to 40 Hz due to their time constraints.

Participants will memorize 15 words ("Rey Auditory Verbal Learning Test") during gamma-tACS or control-tACS. They will be required to recall the words after 5 days. The number of correctly remembered words will be recorded.

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=10 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=10 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Verbal Memory at Day 5
4.1 Number of words recalled
Standard Deviation 2.2
3.9 Number of words recalled
Standard Deviation 2.3

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: One participant was not exposed to 40 Hz due to their time constraints.

Participants will memorize 8 word-pairs during gamma-tACS or control-tACS. They will be required to recall the pairs on the same day. The number of correctly remembered word pairs will be recorded.

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=10 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=10 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Associative Verbal Memory at Day 1
6.1 Number of word pairs recalled
Standard Deviation 0.6
5.7 Number of word pairs recalled
Standard Deviation 1.6

PRIMARY outcome

Timeframe: Follow-Up (Day 2)

Population: One participant was not exposed to 40 Hz due to their time constraints.

Participants will memorize 8 word-pairs during gamma-tACS or control-tACS. They will be required to recall the pairs on the day after. The number of correctly remembered word pairs will be recorded.

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=10 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=10 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Associative Verbal Memory at Day 2
5.9 Number of word pairs recalled
Standard Deviation 0.9
4.7 Number of word pairs recalled
Standard Deviation 1.9

PRIMARY outcome

Timeframe: Follow-Up (Day 5)

Population: One participant was not exposed to 40 Hz due to their time constraints.

Participants will memorize 8 word-pairs during gamma-tACS or control-tACS. They will be required to recall the pairs after 5 days. The number of correctly remembered word pairs will be recorded.

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=10 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=10 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Associative Verbal Memory at Day 5
5.9 Number of word pairs recalled
Standard Deviation 1.2
5.0 Number of word pairs recalled
Standard Deviation 1.7

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: One participant was not exposed to 40 Hz due to their time constraints.

To establish feasibility of at-home use of a single-channel EEG device during sleep. This will be considered feasible if the device has been worn for at least 4 hours during the first night for \>/= 80% of participants.

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=10 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=10 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Percentage of Participants in Which it is Possible to Obtain at Least 4 Hours EEG Recording
60 percentage of participants
60 percentage of participants

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: One participant was not exposed to 40 Hz due to their time constraints.

To establish acceptability of at-home use of the single-channel EEG device during multiple nights. Acceptability will be considered as given if the device has been worn for at least 4 hours during each of the three nights in \>/=80% of participants.

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=10 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=10 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Percentage of Participants Who Wear the EEG Device During All Three Nights for at Least 4 Hours
10 percentage of participants
10 percentage of participants

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: Data were not properly collected for some participants due to technical difficulties.

To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on the number of sleep spindles occuring during the night after the intervention. Sleep spindles during the first two hours of sleep-EEG will be counted. A sleep spindle is defined as a train of sinusoidal waves with frequency 11-16 Hz and a duration of at least 0.5 seconds.

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=5 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=5 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Amount of Sleep Spindles in Sleep-EEG
57.6 Number of sleep spindles
Standard Deviation 116
35.8 Number of sleep spindles
Standard Deviation 64.0

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: Data were not properly collected for some participants due to technical difficulties.

To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on the amount of slow wave sleep (deep/delta sleep) occuring during the night after the intervention. The amount of slow wave sleep during the first two hours of sleep-EEG will be counted.

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=5 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=5 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Amount of Slow Wave Sleep in Sleep-EEG
25.2 minutes
Standard Deviation 31.2
23.2 minutes
Standard Deviation 23.3

SECONDARY outcome

Timeframe: Baseline (Day 1), Follow-Up (Day 2)

Population: One participant was not exposed to 40 Hz due to their time constraints.

To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on a phonematic fluency-task during 1 minute. The number of correct words will be calculated.

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=10 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=10 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Performance in Phonematic Fluency-Correct Words
Baseline
46.0 Number of correct words
Standard Deviation 13.3
45.5 Number of correct words
Standard Deviation 8.1
Performance in Phonematic Fluency-Correct Words
Follow-Up (Day 2)
46.9 Number of correct words
Standard Deviation 10.8
47.8 Number of correct words
Standard Deviation 9.7

SECONDARY outcome

Timeframe: Baseline (Day 1), Follow-Up (Day 2)

Population: One participant was not exposed to 40 Hz due to their time constraints.

To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on a phonematic fluency-task (i.e. production of words that start with a specific letter) during 1 minute. Number of correct words, number of perseverations and number of rule breaks will be calculated.

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=10 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=10 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Performance in Phonematic Fluency-Perseverations
Baseline
1.5 number of perseverations
Standard Deviation 2.1
1.1 number of perseverations
Standard Deviation 1.1
Performance in Phonematic Fluency-Perseverations
Follow-Up (Day 2)
1.3 number of perseverations
Standard Deviation 1.1
1.1 number of perseverations
Standard Deviation 1.9

SECONDARY outcome

Timeframe: Baseline (Day 1), Follow-Up (Day 2)

Population: One participant was not exposed to 40 Hz due to their time constraints.

To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on a phonematic fluency-task during 1 minute. Number of correct words, number of perseverations and number of rule breaks will be calculated.

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=10 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=10 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Performance in Phonematic Fluency-Rule Breaks
Baseline
0.9 number of rule breaks
Standard Deviation 1.1
0.7 number of rule breaks
Standard Deviation 1.3
Performance in Phonematic Fluency-Rule Breaks
Follow-Up (Day 2)
2.0 number of rule breaks
Standard Deviation 2.0
1.0 number of rule breaks
Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline (Day 1), Follow-Up (Day 2)

Population: One participant was not exposed to 40 Hz due to their time constraints.

To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on the Stroop Color and Word Test during and on the day after the intervention. Time for test completion and errors will be calculated. Selective attention was evaluated with the Stroop Color Word Interference Test. In the interference portion of this test, the subject identifies the color of ink in which words ("red", "green", or "blue") are printed, requiring the subject to inhibit their natural tendency to read the word. A subject's score is the time taken to identify 50 stimulus items. The time taken to complete the maze is inversely proportional to the cognitive function.

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=10 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=10 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Executive Functioning (Time to Complete Stroop Test)
Baseline
54.5 seconds
Standard Deviation 7.2
58.6 seconds
Standard Deviation 11.5
Executive Functioning (Time to Complete Stroop Test)
Follow-Up (Day 2)
48.5 seconds
Standard Deviation 6.6
53.2 seconds
Standard Deviation 10.1

SECONDARY outcome

Timeframe: Baseline (Day 1), Follow-Up (Day 2)

Population: One participant was not exposed to 40 Hz due to their time constraints. Data were missing for another participant.

To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on the Trail Making Test (TMT; connecting a set of numbers and numbers and letters as quickly as possible while maintaining accuracy) during and on the day after the intervention. The TMT (Part A and Part B) is a measure of visuomotor processing/sequencing speed. Participants must draw a line connecting numbers in ascending order as quickly as possible. Completion time in seconds is recorded (0-120, where lower scores represent better performance). Completion time of Part B is divided by completion time of Part A (Ratio B/A).

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=9 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=9 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Executive Functioning (Trail Making Test)
Baseline (Day 1)
1.7 ratio
Standard Deviation 0.6
1.9 ratio
Standard Deviation 0.8
Executive Functioning (Trail Making Test)
Follow-Up (Day 2)
2.3 ratio
Standard Deviation 0.9
1.9 ratio
Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline (Day 1), Follow-Up (Day 2)

Population: Data are missing for some participants due to technical reasons resulting in data not being saved.

To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on subtests of the Test of Attentional Performance (TAP) during and on the day after the intervention. Percentile ranks for the following subtests will be calculated: Alertness (reaction time under two conditions), Go/NoGo (stimuli that require a selective reaction, that is, to react or not to react), Divided Attention (a visual and an auditory task must be processed in parallel), Visual Scanning (a matrix-like arrangement of 5 x 5 stimuli is used, the aim being to detect whether this arrangement includes a critical stimulus or not).

Outcome measures

Outcome measures
Measure
Gamma (40Hz) Stimulation
n=10 Participants
Participants who received gamma (40Hz) tACS Gamma transcranial alternating current stimulation: tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Active Control (21 Hz) Stimulation
n=10 Participants
Participants who received (21Hz) tACS Control transcranial alternating current stimulation: tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
Attentional Performance (TAP)
Baseline (Day 1) Alertness
31.4 percentile rank
Standard Deviation 26.6
32.3 percentile rank
Standard Deviation 26.0
Attentional Performance (TAP)
Baseline (Day 1) Go/NoGo
42.8 percentile rank
Standard Deviation 37.2
56.1 percentile rank
Standard Deviation 26.7
Attentional Performance (TAP)
Baseline (Day 1) Divided Attention Acoustic
26.2 percentile rank
Standard Deviation 31.9
13.8 percentile rank
Standard Deviation 16.2
Attentional Performance (TAP)
Baseline (Day 1) Divided Attention Visual
42.6 percentile rank
Standard Deviation 28.2
38.4 percentile rank
Standard Deviation 28.1
Attentional Performance (TAP)
Baseline (Day 1) Visual Scanning Critical
65.0 percentile rank
Standard Deviation 27.4
67.0 percentile rank
Standard Deviation 24.5
Attentional Performance (TAP)
Baseline (Day 1) Visual Scanning Non-Critical
42.8 percentile rank
Standard Deviation 27.2
39.0 percentile rank
Standard Deviation 29.3
Attentional Performance (TAP)
Follow-Up (Day 2) Alertness
39.2 percentile rank
Standard Deviation 29.9
36.2 percentile rank
Standard Deviation 31.3
Attentional Performance (TAP)
Follow-Up (Day 2) Go/NoGo
44.0 percentile rank
Standard Deviation 31.5
47.6 percentile rank
Standard Deviation 35.6
Attentional Performance (TAP)
Follow-Up (Day 2) Divided Attention Acoustic
24.1 percentile rank
Standard Deviation 25.0
19.0 percentile rank
Standard Deviation 20.1
Attentional Performance (TAP)
Follow-Up (Day 2) Divided Attention Visual
48.4 percentile rank
Standard Deviation 28.6
57.3 percentile rank
Standard Deviation 23.4
Attentional Performance (TAP)
Follow-Up (Day 2) Visual Scanning Critical
72.4 percentile rank
Standard Deviation 29.0
72.0 percentile rank
Standard Deviation 28.5
Attentional Performance (TAP)
Follow-Up (Day 2) Visual Scanning Non-Critical
47.8 percentile rank
Standard Deviation 28.8
50.5 percentile rank
Standard Deviation 28.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1), Follow-Up (Day 2)

A relationship is defined as a correlation (Pearson's) between memory recall performance (amount of words recalled) and sleep EEG features (especially spindles, slow waves), i.e., whether better memory recall is associated with more sleep spindles and more slow wave sleep in the night after stimulation.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1), Follow-Up (Day 2)

To see whether there is a correlation (Pearson's) between type of stimulation/wearing EEG and the motor activity pattern (measured by actigraphy wristband).

Outcome measures

Outcome data not reported

Adverse Events

First Gamma (40Hz) Stimulation

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

First Active Control (21 Hz) Stimulation

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

Andrea Seiler, MD

University of North Carolina at Chapel Hill

Phone: +41 316322111

Results disclosure agreements

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