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Targeting Inter-Hemispheric Alpha Coherence With tACS To Treat PMDD

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ClinicalTrials.gov Identifier: NCT02362191
Recruitment Status : Terminated (The study was terminated because the dense treatment schedule precluded successful recruitment of study participants.)
First Posted : February 12, 2015
Last Update Posted : June 24, 2020
Sponsor:
Collaborator:
Foundation of Hope, North Carolina
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

Purpose: Using transcranial alternating current stimulation (tACS), in Experiment 1 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. A secondary 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). If hypotheses for Experiment 1 are supported, we will proceed with Experiment 2 which is a sham (placebo) controlled treatment trial.

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

Procedures (methods): Experiment 1: 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).

Experiment 2: Participants will begin daily ratings and have baseline EEG performed during the follicular and luteal phases of their menstrual cycle. Following the luteal phase EEG, the patient will receive, in a double blind cross-over fashion, 5 days of tACS, 40 minutes/session, performed in two successive months. On the first and fifth days of each treatment, EEG will be performed. Patients' symptoms will be assessed at the end of each session and with the daily mood ratings across the menstrual cycle .


Condition or disease Intervention/treatment Phase
Premenstrual Dysphoric Disorder Device: Alternating current stimulator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Experiment 1: follows the classical cross-over design, where all participants receive stimulation in both menstrual cycle phases. The order of cycle phase at first test session will be counterbalanced.

Experiment 2: also follows the classical cross-over design, where all participants receive both sham and active tACS. The order in which the patients receive the sham versus active tACS will be randomized.

Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Targeting Inter-Hemispheric Alpha Coherence With tACS To Treat PMDD
Study Start Date : March 2015
Actual Primary Completion Date : March 2020
Actual Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experiment 2: tACS Active
Participants will receive 40 minutes of transcranial alternating current stimulation (tACS) produced by an alternating current stimulator.
Device: Alternating current stimulator
The stimulator used in this study was developed by the Frohlich lab and has been reviewed by the biomedical engineering department. The stimulator has multiple safety features and is considered to be non-significant risk.

Sham Comparator: Experiment 2: Sham stimulation
Participants will receive approximately 1 minute of tACS produced by the stimulator in order to maintain blinding.
Device: Alternating current stimulator
The stimulator used in this study was developed by the Frohlich lab and has been reviewed by the biomedical engineering department. The stimulator has multiple safety features and is considered to be non-significant risk.

Experimental: Experiment 1: Follicular-Luteal
Participant has been assigned to receive their first active stimulation session during the follicular phase of their cycle
Device: Alternating current stimulator
The stimulator used in this study was developed by the Frohlich lab and has been reviewed by the biomedical engineering department. The stimulator has multiple safety features and is considered to be non-significant risk.

Experimental: Experiment 1: Luteal-Follicular
Participant has been assigned to receive their first active stimulation session during the luteal phase of their cycle
Device: Alternating current stimulator
The stimulator used in this study was developed by the Frohlich lab and has been reviewed by the biomedical engineering department. The stimulator has multiple safety features and is considered to be non-significant risk.




Primary Outcome Measures :
  1. Mood improvement per DRSP [ Time Frame: 7 days prior to the onset of menses on two consecutive months. ]
    Mood will be assessed on a daily basis for one baseline month and two treatment months using Endicott et al.'s Daily Rating of Severity of Problems. Mood improvement will be qualified as either decreased number of mood symptoms (e.g. sadness, irritability, mood swings), or decreased severity of the subject's primary PMDD symptom(s) compared to the baseline period.


Secondary Outcome Measures :
  1. Alpha band synchronization as recorded by EEG [ Time Frame: Day 5 of tACS/sham treatment as compared to day 0 of tACS/sham treatment. ]
    Electroencephalography (EEG) recordings before the first and after the last tACS and sham treatments.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria included:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362191


Sponsors and Collaborators
University of North Carolina, Chapel Hill
Foundation of Hope, North Carolina
Investigators
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Principal Investigator: David R Rubinow, MD Dept of Psychiatry, UNC School of Medicine
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02362191    
Other Study ID Numbers: 14-0600
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Premenstrual Dysphoric Disorder
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes
Depressive Disorder
Mood Disorders
Mental Disorders