Trial Outcomes & Findings for Targeting Inter-Hemispheric Alpha Coherence With tACS To Treat PMDD (NCT NCT02362191)

Last Updated: 2020-10-09

Results Overview

Fast Fourier transform is applied to 8 minutes of EEG data before and after tACS. 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

TERMINATED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

8-minute recording before vs after intervention

Results posted on

2020-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	Single Session tACS Across Menstrual Cycle Participants assigned to receive a single session of tACS during the follicular and luteal phase of their menstrual cycle. Alternating Current Stimulator: 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.
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Targeting Inter-Hemispheric Alpha Coherence With tACS To Treat PMDD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Session tACS Across Menstrual Cycle n=5 Participants Participants assigned to receive a single session of tACS during the follicular and luteal phase of their menstrual cycle. Alternating Current Stimulator: 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.
Age, Continuous	28.8 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 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	1 Participants n=5 Participants
Race (NIH/OMB) White	4 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	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8-minute recording before vs after intervention

Outcome measures

Outcome measures
Measure	Single Session tACS Across Menstrual Cycle n=3 Participants Participants assigned to receive a single session of tACS during the follicular and luteal phase of their menstrual cycle. Alternating Current Stimulator: 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.
Change in Alpha Frequency Electrical Activity in Left Frontal Cortex Following Stimulation	0.044 microvolts Standard Deviation 0.218

SECONDARY outcome

Timeframe: Over the course of 2 menstrual cycles, pre-post EEG recordings will occur, one during the follicular phase (5-9 days after menstruation) and one in the luteal, premenstrual phase (9-13 days after ovulation)

Comparison of the change in EEG left prefrontal activity following tACS in luteal vs. follicular phases measured by the luteal pre to post change in EEG compared with the follicular pre to post change in EEG. Pre-post EEG recordings will occur during the follicular phase (5-9 days after menstruation) and in the luteal, premenstrual phase (9-13 days after ovulation).

Outcome measures

Outcome measures
Measure	Single Session tACS Across Menstrual Cycle n=3 Participants Participants assigned to receive a single session of tACS during the follicular and luteal phase of their menstrual cycle. Alternating Current Stimulator: 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.
Difference in Magnitude of Effect of tACS on Left Prefrontal Alpha in Follicular vs Luteal Phase	-0.191 microvolts Standard Deviation 0.313

Adverse Events

Single Session tACS Across Menstrual Cycle

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

David Rubinow, MD

University of North Carolina at Chapel Hill

Phone: 919-445-0220

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place