Trial Outcomes & Findings for Single Session of tACS in a Depressive Episode (NCT NCT03449979)
NCT ID: NCT03449979
Last Updated: 2020-06-04
Results Overview
Fast Fourier transform is applied to 5 minutes of EEG data before and after intervention. Primary outcome is the difference in alpha frequency amplitude (8-12 Hz) in the left frontal cortex from baseline as a result of intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
5 minute recording before and after intervention
Results posted on
2020-06-04
Participant Flow
Participant milestones
| Measure |
Alpha Stimulation in Participants in a Depressive Episode
Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
Sham Stimulation in Participants in a Depressive Episode
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
Alpha Stimulation in Healthy Participants
Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
Sham Stimulation in Healthy Participants
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
21
|
22
|
|
Overall Study
COMPLETED
|
21
|
20
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Alpha Stimulation in Participants in a Depressive Episode
Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
Sham Stimulation in Participants in a Depressive Episode
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
Alpha Stimulation in Healthy Participants
Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
Sham Stimulation in Healthy Participants
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
|---|---|---|---|---|
|
Overall Study
Technical difficulty
|
0
|
0
|
0
|
1
|
Baseline Characteristics
One healthy control participant that received sham stimulation was excluded from analysis as we were unable to find an age and sex matched participant. One healthy control participant that received sham stimulation did not complete the study due to technical difficulties.
Baseline characteristics by cohort
| Measure |
Alpha Stimulation in Participants in a Depressive Episode
n=21 Participants
Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
Sham Stimulation in Participants in a Depressive Episode
n=20 Participants
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
Alpha Stimulation in Healthy Participants
n=21 Participants
Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
Sham Stimulation in Healthy Participants
n=22 Participants
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
28.429 years
STANDARD_DEVIATION 11.902 • n=21 Participants
|
27.65 years
STANDARD_DEVIATION 12.227 • n=20 Participants
|
28.095 years
STANDARD_DEVIATION 11.432 • n=21 Participants
|
27.182 years
STANDARD_DEVIATION 12.133 • n=22 Participants
|
27.796 years
STANDARD_DEVIATION 11.831 • n=84 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=21 Participants
|
16 Participants
n=20 Participants
|
17 Participants
n=21 Participants
|
17 Participants
n=22 Participants
|
67 Participants
n=84 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=21 Participants
|
4 Participants
n=20 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=22 Participants
|
17 Participants
n=84 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=21 Participants
|
1 Participants
n=20 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
9 Participants
n=84 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=21 Participants
|
19 Participants
n=20 Participants
|
14 Participants
n=21 Participants
|
17 Participants
n=22 Participants
|
70 Participants
n=84 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
5 Participants
n=84 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=84 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=21 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=22 Participants
|
13 Participants
n=84 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=84 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=21 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=22 Participants
|
12 Participants
n=84 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=21 Participants
|
16 Participants
n=20 Participants
|
13 Participants
n=21 Participants
|
10 Participants
n=22 Participants
|
54 Participants
n=84 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=21 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
5 Participants
n=84 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=84 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=21 Participants
|
20 Participants
n=20 Participants
|
21 Participants
n=21 Participants
|
22 Participants
n=22 Participants
|
84 Participants
n=84 Participants
|
|
Alpha oscillations in left frontal cortex before stimulation
|
0.789 microvolts
STANDARD_DEVIATION 0.088 • n=21 Participants • One healthy control participant that received sham stimulation was excluded from analysis as we were unable to find an age and sex matched participant. One healthy control participant that received sham stimulation did not complete the study due to technical difficulties.
|
0.812 microvolts
STANDARD_DEVIATION 0.056 • n=20 Participants • One healthy control participant that received sham stimulation was excluded from analysis as we were unable to find an age and sex matched participant. One healthy control participant that received sham stimulation did not complete the study due to technical difficulties.
|
0.826 microvolts
STANDARD_DEVIATION 0.076 • n=21 Participants • One healthy control participant that received sham stimulation was excluded from analysis as we were unable to find an age and sex matched participant. One healthy control participant that received sham stimulation did not complete the study due to technical difficulties.
|
0.845 microvolts
STANDARD_DEVIATION 0.095 • n=20 Participants • One healthy control participant that received sham stimulation was excluded from analysis as we were unable to find an age and sex matched participant. One healthy control participant that received sham stimulation did not complete the study due to technical difficulties.
|
0.818 microvolts
STANDARD_DEVIATION 0.081 • n=82 Participants • One healthy control participant that received sham stimulation was excluded from analysis as we were unable to find an age and sex matched participant. One healthy control participant that received sham stimulation did not complete the study due to technical difficulties.
|
PRIMARY outcome
Timeframe: 5 minute recording before and after interventionPopulation: One of the healthy participants that received sham stimulation could not be age and sex matched, therefore, we did not analyze this participant.
Fast Fourier transform is applied to 5 minutes of EEG data before and after intervention. Primary outcome is the difference in alpha frequency amplitude (8-12 Hz) in the left frontal cortex from baseline as a result of intervention.
Outcome measures
| Measure |
Alpha Stimulation in Participants in a Depressive Episode
n=21 Participants
Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
Sham Stimulation in Participants in a Depressive Episode
n=20 Participants
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
Alpha Stimulation in Healthy Participants
n=21 Participants
Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
Sham Stimulation in Healthy Participants
n=20 Participants
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
|---|---|---|---|---|
|
Change in Alpha Frequency Electrical Activity in Left Frontal Cortex From Stimulation
|
-0.005 microvolts
Standard Deviation 0.022
|
0.008 microvolts
Standard Deviation 0.023
|
0.004 microvolts
Standard Deviation 0.017
|
0.007 microvolts
Standard Deviation 0.022
|
Adverse Events
Alpha Stimulation in Patients in a Depressive Episode
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Sham Stimulation in Patients in a Depressive Episode
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Alpha Stimulation in Healthy Participants
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Sham Stimulation in Healthy Participants
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alpha Stimulation in Patients in a Depressive Episode
n=21 participants at risk
Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
Sham Stimulation in Patients in a Depressive Episode
n=20 participants at risk
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
Alpha Stimulation in Healthy Participants
n=21 participants at risk
Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
Sham Stimulation in Healthy Participants
n=22 participants at risk
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
|---|---|---|---|---|
|
Investigations
Tingling
|
33.3%
7/21 • Number of events 7 • Adverse events were collected over the 5 hours of the single session experiment
|
10.0%
2/20 • Number of events 2 • Adverse events were collected over the 5 hours of the single session experiment
|
33.3%
7/21 • Number of events 7 • Adverse events were collected over the 5 hours of the single session experiment
|
18.2%
4/22 • Number of events 4 • Adverse events were collected over the 5 hours of the single session experiment
|
|
Investigations
Flickering Lights
|
14.3%
3/21 • Number of events 3 • Adverse events were collected over the 5 hours of the single session experiment
|
0.00%
0/20 • Adverse events were collected over the 5 hours of the single session experiment
|
14.3%
3/21 • Number of events 3 • Adverse events were collected over the 5 hours of the single session experiment
|
9.1%
2/22 • Number of events 2 • Adverse events were collected over the 5 hours of the single session experiment
|
|
Investigations
Itching
|
14.3%
3/21 • Number of events 3 • Adverse events were collected over the 5 hours of the single session experiment
|
5.0%
1/20 • Number of events 1 • Adverse events were collected over the 5 hours of the single session experiment
|
0.00%
0/21 • Adverse events were collected over the 5 hours of the single session experiment
|
4.5%
1/22 • Number of events 1 • Adverse events were collected over the 5 hours of the single session experiment
|
|
Investigations
Burning sensation
|
33.3%
7/21 • Number of events 7 • Adverse events were collected over the 5 hours of the single session experiment
|
15.0%
3/20 • Number of events 3 • Adverse events were collected over the 5 hours of the single session experiment
|
14.3%
3/21 • Number of events 3 • Adverse events were collected over the 5 hours of the single session experiment
|
13.6%
3/22 • Number of events 3 • Adverse events were collected over the 5 hours of the single session experiment
|
|
Investigations
Scalp pain
|
14.3%
3/21 • Number of events 3 • Adverse events were collected over the 5 hours of the single session experiment
|
0.00%
0/20 • Adverse events were collected over the 5 hours of the single session experiment
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over the 5 hours of the single session experiment
|
9.1%
2/22 • Number of events 2 • Adverse events were collected over the 5 hours of the single session experiment
|
|
Investigations
Neck pain
|
0.00%
0/21 • Adverse events were collected over the 5 hours of the single session experiment
|
5.0%
1/20 • Number of events 1 • Adverse events were collected over the 5 hours of the single session experiment
|
0.00%
0/21 • Adverse events were collected over the 5 hours of the single session experiment
|
0.00%
0/22 • Adverse events were collected over the 5 hours of the single session experiment
|
|
Investigations
Headache
|
0.00%
0/21 • Adverse events were collected over the 5 hours of the single session experiment
|
5.0%
1/20 • Number of events 1 • Adverse events were collected over the 5 hours of the single session experiment
|
0.00%
0/21 • Adverse events were collected over the 5 hours of the single session experiment
|
0.00%
0/22 • Adverse events were collected over the 5 hours of the single session experiment
|
Additional Information
Justin Riddle, PhD
University of North Carolina at Chapel Hill
Phone: 6617131602
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place