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Targeting Inter-Hemispheric Alpha Coherence With tACS To Treat PMDD

NCT02362191 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-10-09

Study results available
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Summary

Purpose: Using transcranial alternating current stimulation (tACS), we will study whether tACS induces changes in prefrontal alpha oscillatory frequencies in women with premenstrual dysphoric disorder (PMDD) and whether tACS effects on alpha oscillations varies by menstrual cycle phase. An exploratory objective is to assess whether there are any changes in symptom severity during the menstrual cycle phase in which tACS is delivered relative to their baseline symptom levels (determined in a diagnostic feeder study, see below).

Participants: Women between ages 18-52 with a diagnosis of PMDD confirmed by participation in a PMDD diagnostic study (IRB# 05-3000).

Procedures (methods): After a re-screening and consent appointment, eligible participants will alert the study staff when they begin menstruating. Participants will have their first session in either the follicular phase or luteal phase (determined by ovulation testing) of their menstrual cycle and the second session in the other cycle phase. The order of phase at first testing will be counterbalanced across participants. Each session will consist of 40 minutes of tACS with by an EEG recording before and after stimulation. Patients' symptoms will be assessed at the end of each session and with the daily mood ratings collected throughout the menstrual cycle that coincides with tACS sessions (approximately 26 - 32 days).

Conditions

  • Premenstrual Dysphoric Disorder

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Foundation of Hope, North Carolina

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • David R Rubinow, MD · Dept of Psychiatry, UNC School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
52 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2020-03-31
Completion
2020-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02362191 on ClinicalTrials.gov