Targeting Inter-Hemispheric Alpha Coherence With tACS To Treat PMDD

NCT02362191 | Terminated Results

• 1 other identifier: 14-0600
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Alpha Frequency Electrical Activity in Left Frontal Cortex Following Stimulation

  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.

  8-minute recording before vs after intervention

Secondary Outcomes (1)

• Difference in Magnitude of Effect of tACS on Left Prefrontal Alpha in Follicular vs Luteal Phase

  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)

Study Arms (1)

Single Session tACS Across Menstrual Cycle

EXPERIMENTAL

Participants assigned to receive a single session of tACS during the follicular and luteal phase of their menstrual cycle.

Device: Alternating Current Stimulator

Interventions

Alternating Current Stimulator DEVICE

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.

Also known as: XCSITE 100 Stimulator

Single Session tACS Across Menstrual Cycle

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-52;
• Have participated in our PMDD diagnostic study (IRB# 05-3000);
• Regularly menstruating without hormonal contraceptives (e.g., birth control pills, injections, implants, progestin IUDs);
• Medication free or regularly taking medication that has no effect on the nervous system;
• Not currently pregnant or planning to become pregnant;
• With sufficient resources to prevent pregnancy

You may not qualify if:

• Brain surgery or brain implants, including cochlear implants or aneurysm clips
• Neurological disease, like epilepsy or a brain tumor
• Traumatic brain injury
• Pregnant or nursing
• An unstable medical illness, like congestive heart failure or end stage kidney disease
• History of severe or recurrent substance abuse, or any substance abuse within 2 years of study enrollment
• History of suicidal behavior within 5 years of study enrollment
• Department of Psychiatry Faculty, Employee, or Trainee

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Foundation of Hope, North Carolina: collaborator

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder

Condition Hierarchy (Ancestors)

Premenstrual Syndrome; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: David Rubinow, MD
• Organization: University of North Carolina at Chapel Hill

drubinow@med.unc.edu

919-445-0220

Study Officials

• David R Rubinow, MD

  Dept of Psychiatry, UNC School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2014
• First Posted: February 12, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: October 9, 2020
• Results First Posted: October 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share