Trial Outcomes & Findings for Mechanism of Action of tACS for the Treatment of MDD (NCT NCT03994081)

Last Updated: 2024-09-19

Results Overview

Fourier transform is applied to 2 second epochs of resting-state EEG data and averaged across epochs. The amplitude of alpha oscillations is calculated and averaged across left frontal electrodes. The difference between the baseline recording on the first day of stimulation is compared to the recording on the fifth day of the intervention prior to stimulation.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Baseline, Day 5

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Alpha Transcranial Alternating Current Stimulation (tACS) 10 Hz tACS with a zero-to-peak amplitude of 1 mA for 40 minutes. tACS: XCSITE100	Sham Stimulation 20 seconds of ramp-up, 40 seconds of 10 Hz tACS with zero-to-peak amplitude of 1 mA, and 20 seconds of ramp-down for a total of 80 seconds of stimulation. Sham tACS: XCSITE100
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mechanism of Action of tACS for the Treatment of MDD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alpha Transcranial Alternating Current Stimulation (tACS) n=10 Participants 10 Hz tACS with a zero-to-peak amplitude of 1 mA for 40 minutes. tACS: XCSITE100	Sham Stimulation n=10 Participants 20 seconds of ramp-up, 40 seconds of 10 Hz tACS with zero-to-peak amplitude of 1 mA, and 20 seconds of ramp-down for a total of 80 seconds of stimulation. Sham tACS: XCSITE100	Total n=20 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
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 5

Population: Day 5 - Day 1

Outcome measures

Outcome measures
Measure	Alpha Transcranial Alternating Current Stimulation (tACS) n=10 Participants 10 Hz tACS with a zero-to-peak amplitude of 1 mA for 40 minutes. tACS: XCSITE100	Sham Stimulation n=10 Participants 20 seconds of ramp-up, 40 seconds of 10 Hz tACS with zero-to-peak amplitude of 1 mA, and 20 seconds of ramp-down for a total of 80 seconds of stimulation. Sham tACS: XCSITE100
Change in the Amplitude of Left Frontal Alpha Oscillations Measured Durin Resting-state EEG Recordings From Baseline to Day 5 of Stimulation.	0.042 microvolts^2/Hz Standard Deviation 0.221	0.169 microvolts^2/Hz Standard Deviation 0.338

PRIMARY outcome

Timeframe: Baseline, two-week follow-up visit

Population: Data for 1 participant unavailable due to missed visit.

Outcome measures

Outcome measures
Measure	Alpha Transcranial Alternating Current Stimulation (tACS) n=9 Participants 10 Hz tACS with a zero-to-peak amplitude of 1 mA for 40 minutes. tACS: XCSITE100	Sham Stimulation n=10 Participants 20 seconds of ramp-up, 40 seconds of 10 Hz tACS with zero-to-peak amplitude of 1 mA, and 20 seconds of ramp-down for a total of 80 seconds of stimulation. Sham tACS: XCSITE100
Change in the Amplitude of Left Frontal Alpha Oscillations Measured During Resting-state EEG Recordings From Baseline to Two-week Follow-up of Stimulation.	-0.016 microvolts^2/Hz Standard Deviation 0.199	0.012 microvolts^2/Hz Standard Deviation 0.243

SECONDARY outcome

Timeframe: Baseline, Day 5

Correlation Coefficient (r) will be used to determine if there is a relationship between the change in Hamilton Depression Rating Scale (HDRS) scores from baseline to Day 5 and the two-week follow up and change in the amplitude of left frontal alpha oscillations before stimulation at baseline and Day 5 of stimulation. The HDRS is a clinician-rated measure of depression severity where higher scores indicate greater depression severity. To calculate the amplitude of left frontal alpha oscillations, Fourier transform is applied to 2 second epochs of resting-state EEG data and averaged across epochs. The amplitude of alpha oscillations is calculated and averaged across left frontal electrodes.

Outcome measures

Outcome measures
Measure	Alpha Transcranial Alternating Current Stimulation (tACS) n=10 Participants 10 Hz tACS with a zero-to-peak amplitude of 1 mA for 40 minutes. tACS: XCSITE100	Sham Stimulation n=10 Participants 20 seconds of ramp-up, 40 seconds of 10 Hz tACS with zero-to-peak amplitude of 1 mA, and 20 seconds of ramp-down for a total of 80 seconds of stimulation. Sham tACS: XCSITE100
Correlation Between Changes in the Amplitude of Left Frontal Alpha Oscillations From Baseline to Day 5 of Intervention and Changes in Symptoms of Depression.	-0.263 Pearson Correlation Coefficient	-0.109 Pearson Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, two-week follow-up visit

Population: Data for 1 participant unavailable due to missed visit.

Correlation Coefficient (r) will be used to determine if there is a relationship between the change in Hamilton Depression Rating Scale (HDRS) scores from baseline, Day 5 and to two-week follow up and change in the amplitude of left frontal alpha oscillations before stimulation at baseline and Day 5 of stimulation. The HDRS is a clinician-rated measure of depression severity where higher scores indicate greater depression severity. To calculate the amplitude of left frontal alpha oscillations, Fourier transform is applied to 2 second epochs of resting-state EEG data and averaged across epochs. The amplitude of alpha oscillations is calculated and averaged across left frontal electrodes.

Outcome measures

Outcome measures
Measure	Alpha Transcranial Alternating Current Stimulation (tACS) n=9 Participants 10 Hz tACS with a zero-to-peak amplitude of 1 mA for 40 minutes. tACS: XCSITE100	Sham Stimulation n=10 Participants 20 seconds of ramp-up, 40 seconds of 10 Hz tACS with zero-to-peak amplitude of 1 mA, and 20 seconds of ramp-down for a total of 80 seconds of stimulation. Sham tACS: XCSITE100
Correlation Between Changes in the Amplitude of Left Frontal Alpha Oscillations From Baseline to Two-week Follow-up and Depression Symptoms.	0.624 Pearson Correlation Coefficient	0.087 Pearson Correlation Coefficient

Adverse Events

Alpha Transcranial Alternating Current Stimulation (tACS)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Sham Stimulation

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Tobias Schwippel, MD

University of North Carolina at Chapel Hill

Phone: 919-966-9929

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Alpha Transcranial Alternating Current Stimulation (tACS) n=10 participants at risk 10 Hz tACS with a zero-to-peak amplitude of 1 mA for 40 minutes. tACS: XCSITE100	Sham Stimulation n=10 participants at risk 20 seconds of ramp-up, 40 seconds of 10 Hz tACS with zero-to-peak amplitude of 1 mA, and 20 seconds of ramp-down for a total of 80 seconds of stimulation. Sham tACS: XCSITE100
Nervous system disorders Headache	70.0% 7/10 • Number of events 14 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up	70.0% 7/10 • Number of events 27 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up
Nervous system disorders Restlessness	60.0% 6/10 • Number of events 13 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up	30.0% 3/10 • Number of events 6 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up
Nervous system disorders Vision Changes	10.0% 1/10 • Number of events 1 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up	30.0% 3/10 • Number of events 4 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up
Musculoskeletal and connective tissue disorders Pain	20.0% 2/10 • Number of events 8 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up	20.0% 2/10 • Number of events 6 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up
Nervous system disorders Nausea	0.00% 0/10 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up	50.0% 5/10 • Number of events 7 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up
Nervous system disorders Fatigue	70.0% 7/10 • Number of events 25 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up	90.0% 9/10 • Number of events 28 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up
Gastrointestinal disorders Diarrhea	0.00% 0/10 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up	20.0% 2/10 • Number of events 3 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up
Nervous system disorders Dizziness	10.0% 1/10 • Number of events 1 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up	20.0% 2/10 • Number of events 5 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up
Musculoskeletal and connective tissue disorders Muscle Cramps	20.0% 2/10 • Number of events 2 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up	20.0% 2/10 • Number of events 2 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up
Skin and subcutaneous tissue disorders Skin Irritation	20.0% 2/10 • Number of events 2 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up	20.0% 2/10 • Number of events 2 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up
Psychiatric disorders Suicidal Ideation	10.0% 1/10 • Number of events 1 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up	0.00% 0/10 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up
Psychiatric disorders Anxiety	10.0% 1/10 • Number of events 1 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up	0.00% 0/10 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up
General disorders Feeling cold	10.0% 1/10 • Number of events 1 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up	0.00% 0/10 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up
Eye disorders Eye Twitching	10.0% 1/10 • Number of events 1 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up	0.00% 0/10 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up
Psychiatric disorders Vivid Dreams	10.0% 1/10 • Number of events 1 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up	0.00% 0/10 • Adverse Events were assessed at Day 1, Day 2, Day 3, Day 4, Day 5 and 2-week follow-up