Trial Outcomes & Findings for Transcranial Alternating Current Stimulation for Major Depressive Disorder (NCT NCT02339285)
NCT ID: NCT02339285
Last Updated: 2018-08-20
Results Overview
The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). A comparison of MADRS scores between baseline and F2 is the primary outcome measure (measured as change from baseline). In these results, negative values will indicate a decrease in depressive symptoms.
COMPLETED
NA
32 participants
Baseline to F2 (4 weeks after completion of the intervention)
2018-08-20
Participant Flow
Participants were recruited through advertisements (e.g., online, flyers) and self-identified with depression. Interested participants contacted the study team.
Participants were randomly assigned to 1 of 3 arms: tACS (alpha), tACS (gamma), or sham stimulation. All conditions were delivered during awake, resting state for 40 minutes on 5 consecutive days. 98 participants signed consent, 40 did not meet criteria, 6 declined participation, and 20 were excluded for other reasons. 32 were randomized.
Participant milestones
| Measure |
tACS (Alpha)
10 Hz transcranial alternating current stimulation (tACS) with a peak-to-peak amplitude of 2 mA for 40 minutes
|
tACS (Gamma)
40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
Sham Stimulation
Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
11
|
|
Overall Study
Completed Intervention
|
10
|
10
|
10
|
|
Overall Study
2 Week Follow-up
|
9
|
10
|
10
|
|
Overall Study
4 Week Follow-up Visit
|
9
|
8
|
9
|
|
Overall Study
COMPLETED
|
9
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
2
|
Reasons for withdrawal
| Measure |
tACS (Alpha)
10 Hz transcranial alternating current stimulation (tACS) with a peak-to-peak amplitude of 2 mA for 40 minutes
|
tACS (Gamma)
40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
Sham Stimulation
Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
0
|
Baseline Characteristics
Transcranial Alternating Current Stimulation for Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
tACS (Alpha)
n=10 Participants
10 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
tACS (Gamma)
n=11 Participants
40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
Sham Stimulation
n=11 Participants
Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.30 years
STANDARD_DEVIATION 15.22 • n=5 Participants
|
35.36 years
STANDARD_DEVIATION 11.56 • n=7 Participants
|
38.36 years
STANDARD_DEVIATION 13.54 • n=5 Participants
|
36.69 years
STANDARD_DEVIATION 13.08 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
28.80 units on a scale
STANDARD_DEVIATION 6.36 • n=5 Participants
|
25.00 units on a scale
STANDARD_DEVIATION 7.21 • n=7 Participants
|
24.55 units on a scale
STANDARD_DEVIATION 5.18 • n=5 Participants
|
26.03 units on a scale
STANDARD_DEVIATION 6.39 • n=4 Participants
|
|
Hamilton Depression Rating Scale (HDRS)
|
17.90 units on a scale
STANDARD_DEVIATION 4.51 • n=5 Participants
|
14.64 units on a scale
STANDARD_DEVIATION 3.53 • n=7 Participants
|
14.55 units on a scale
STANDARD_DEVIATION 6.12 • n=5 Participants
|
15.63 units on a scale
STANDARD_DEVIATION 4.94 • n=4 Participants
|
|
Beck Depression Inventory (BDI)
|
26.60 units on a scale
STANDARD_DEVIATION 5.58 • n=5 Participants
|
28.27 units on a scale
STANDARD_DEVIATION 8.81 • n=7 Participants
|
26.18 units on a scale
STANDARD_DEVIATION 9.74 • n=5 Participants
|
27.03 units on a scale
STANDARD_DEVIATION 8.10 • n=4 Participants
|
|
Montreal Cognitive Assessment (MoCA)
|
28.20 units on a scale
STANDARD_DEVIATION 1.99 • n=5 Participants
|
27.27 units on a scale
STANDARD_DEVIATION 1.62 • n=7 Participants
|
27.82 units on a scale
STANDARD_DEVIATION 2.48 • n=5 Participants
|
27.75 units on a scale
STANDARD_DEVIATION 2.00 • n=4 Participants
|
|
Clinical Global Impression (CGI)
|
4.10 units on a scale
STANDARD_DEVIATION 0.99 • n=5 Participants
|
3.82 units on a scale
STANDARD_DEVIATION 0.60 • n=7 Participants
|
3.73 units on a scale
STANDARD_DEVIATION 0.79 • n=5 Participants
|
3.88 units on a scale
STANDARD_DEVIATION 0.79 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to F2 (4 weeks after completion of the intervention)The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). A comparison of MADRS scores between baseline and F2 is the primary outcome measure (measured as change from baseline). In these results, negative values will indicate a decrease in depressive symptoms.
Outcome measures
| Measure |
tACS (Alpha)
n=10 Participants
10 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
tACS (Gamma)
n=11 Participants
40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
Sham Stimulation
n=11 Participants
Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation.
|
|---|---|---|---|
|
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
|
-13.60 units on a scale
Standard Deviation 7.75
|
-8.82 units on a scale
Standard Deviation 8.94
|
-8.27 units on a scale
Standard Deviation 10.88
|
SECONDARY outcome
Timeframe: Baseline to Day 5 of StimulationPopulation: Only participants that completed all sessions are used in this task (per protocol participants); N = 26
The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and last day of stimulation. The investigators will also collect EEG recordings data at a visit four weeks after completion of the intervention (F2). The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions.
Outcome measures
| Measure |
tACS (Alpha)
n=9 Participants
10 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
tACS (Gamma)
n=8 Participants
40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
Sham Stimulation
n=9 Participants
Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation.
|
|---|---|---|---|
|
Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation
All Brain Regions
|
-1.75 decibel (dB)
Standard Deviation 1.75
|
0.53 decibel (dB)
Standard Deviation 1.79
|
0.24 decibel (dB)
Standard Deviation 1.22
|
|
Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation
Frontal Brain Regions
|
-1.23 decibel (dB)
Standard Deviation 1.29
|
0.12 decibel (dB)
Standard Deviation 1.68
|
-0.02 decibel (dB)
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: Baseline to F2Population: Only participants that completed all sessions are used in this task (per protocol participants); N = 26
The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and at the follow-up visit four weeks after completion of the intervention. The investigators will also collect EEG on the fifth day of stimulation. The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions.
Outcome measures
| Measure |
tACS (Alpha)
n=9 Participants
10 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
tACS (Gamma)
n=8 Participants
40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
Sham Stimulation
n=9 Participants
Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation.
|
|---|---|---|---|
|
Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention
All Brain Regions
|
-0.42 decibel (dB)
Standard Deviation 2.35
|
0.09 decibel (dB)
Standard Deviation 1.76
|
0.55 decibel (dB)
Standard Deviation 1.17
|
|
Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention
Frontal Brain Regions
|
-0.57 decibel (dB)
Standard Deviation 1.89
|
0.00 decibel (dB)
Standard Deviation 1.60
|
0.41 decibel (dB)
Standard Deviation 1.18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 5 of Stimulation; Baseline to F2The HDRS is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2, with negative values indicating a decrease in depressive symptoms.
Outcome measures
| Measure |
tACS (Alpha)
n=10 Participants
10 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
tACS (Gamma)
n=11 Participants
40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
Sham Stimulation
n=11 Participants
Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation.
|
|---|---|---|---|
|
Change in Hamilton Depression Rating Scale (HDRS) Score
Day 5 change
|
-6.00 units on a scale
Standard Deviation 3.09
|
-4.45 units on a scale
Standard Deviation 5.41
|
-3.09 units on a scale
Standard Deviation 4.48
|
|
Change in Hamilton Depression Rating Scale (HDRS) Score
F2 change
|
-8.50 units on a scale
Standard Deviation 5.04
|
-4.73 units on a scale
Standard Deviation 5.61
|
-4.64 units on a scale
Standard Deviation 6.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to F2This measurement will be taken at baseline (first day of stimulation) and four weeks after completion of the intervention (F2). Total score ranges from 0 to 30, with higher values indicating better cognition. The investigators will compare the scores between baseline and F2. Reported values are the raw change (increase or decrease) from baseline.
Outcome measures
| Measure |
tACS (Alpha)
n=10 Participants
10 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
tACS (Gamma)
n=11 Participants
40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
Sham Stimulation
n=11 Participants
Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation.
|
|---|---|---|---|
|
Change in Montreal Cognitive Assessment (MoCA) Score
|
0.50 units on a scale
Standard Deviation 0.53
|
1.27 units on a scale
Standard Deviation 1.35
|
1.09 units on a scale
Standard Deviation 1.51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 5; Baseline to F2This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). Higher scores indicate more depressive symptoms. Total score is out of 63 possible. The investigators will compare the scores between baseline and F2. In these results, negative values indicate a decrease in depressive symptoms.
Outcome measures
| Measure |
tACS (Alpha)
n=10 Participants
10 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
tACS (Gamma)
n=11 Participants
40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
Sham Stimulation
n=11 Participants
Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation.
|
|---|---|---|---|
|
Change in Beck Depression Inventory (BDI) Score
Day 5 Change
|
-8.60 units on a scale
Standard Deviation 6.42
|
-9.64 units on a scale
Standard Deviation 10.07
|
-7.18 units on a scale
Standard Deviation 7.19
|
|
Change in Beck Depression Inventory (BDI) Score
F2 change
|
-14.80 units on a scale
Standard Deviation 12.39
|
-11.09 units on a scale
Standard Deviation 11.68
|
-10.64 units on a scale
Standard Deviation 10.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 5; F2 (4 weeks after completion of treatment)This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2.The reported values are from Item 1 "Severity of Illness" on a likert scale of 1 to 7, with 1=Normal, not at all ill and 7 = Among the most extremely ill patients.
Outcome measures
| Measure |
tACS (Alpha)
n=10 Participants
10 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
tACS (Gamma)
n=11 Participants
40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes
|
Sham Stimulation
n=11 Participants
Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation.
|
|---|---|---|---|
|
Clinical Global Impressions (CGI) Raw Score
Day 5 Score
|
4.30 units on a scale
Standard Deviation 0.95
|
3.73 units on a scale
Standard Deviation 0.65
|
3.73 units on a scale
Standard Deviation 0.79
|
|
Clinical Global Impressions (CGI) Raw Score
F2 Score
|
3.90 units on a scale
Standard Deviation 1.37
|
3.82 units on a scale
Standard Deviation 0.75
|
3.45 units on a scale
Standard Deviation 1.29
|
Adverse Events
tACS (Alpha)
tACS (Gamma)
Sham Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Flavio Frohlich
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place