RecruitingACTRN12622000909729

Transcranial Magnetic Stimulation (TMS) to Treat Premenstrual Dysphoric Disorder

Efficacy of Theta Burst Transcranial Magnetic Stimulation for the Treatment of Premenstrual Dysphoric Disorder – An Open Label Pilot Study


Sponsor

Monash University

Enrollment

30 participants

Start Date

Nov 25, 2022

Study Type

Interventional

Conditions

Summary

Premenstrual dysphoric disorder (PMDD) is a severe, cyclical depressive disorder that affects 2-8% of women of reproductive age. Previously known as late luteal phase dysphoric disorder, PMDD is characterised by irritability, mood changes/swings and physical symptoms of that develop during the luteal phase of the menstrual cycle and resolve after the commencement of menses. PMDD carries significant distress and morbidity, for which limited therapeutic options exist. The urgent and clear need exists for effective and harmless treatments in PMDD. The scope exists to investigate novel therapeutic modalities for this crippling disorder for many. The proposed project meets this need by investigating the efficacy of application of Theta Burst Stimulation (TBS) in PMDD in the form of a pilot study. Transcranial Magnetic Stimulation (TMS) is a non-invasive means of stimulating nerve cells in superficial areas of the brain. TBS (a patterned form of TMS) has been approved by the FDA as a treatment for treatment-resistant major depression. TBS has received minimal research attention as a potential treatment for PMDD. The research project aims to evaluate if theta burst stimulation (TBS) is effective in treating mood and other psychological symptoms in PMDD.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome that affects 2–8% of people of reproductive age. Unlike ordinary PMS, PMDD causes intense mood changes, irritability, and depression in the week before a period that can seriously disrupt daily life. Current treatments — including antidepressants and hormonal therapies — don't work for everyone, and some people prefer not to take medication. This study investigates whether a type of brain stimulation called Theta Burst Stimulation (TBS) — a non-invasive technique that uses magnetic pulses to stimulate areas of the brain involved in mood regulation — can reduce the psychological symptoms of PMDD. TBS is already approved for treating depression and has a good safety record. Participants receive TBS during the luteal phase of their menstrual cycle (the week before their period begins). You may be eligible if you are a woman aged 18–45 with a confirmed PMDD diagnosis, have experienced symptoms for at least a year, and are not currently pregnant. You are not eligible if you have certain neurological conditions (such as a history of seizures), are at risk of suicide, or have a serious mental health condition other than depression. The study runs as a small pilot to assess whether TBS shows enough promise to study in a larger trial.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Female participants, aged 18-45, will receive daily sessions of Theta-burst stimulation (TBS) applied over 5 continuous days in the luteal phase (10 +/- 2 days after ovulation) in the treatment phase

Female participants, aged 18-45, will receive daily sessions of Theta-burst stimulation (TBS) applied over 5 continuous days in the luteal phase (10 +/- 2 days after ovulation) in the treatment phase (Month 3 of study). TMS will be administered at the Monash Alfred Psychiatry Research Centre (MAPrc) by trained research staff. Stimulation is applied to the left dorsolateral prefrontal cortex (DLPFC), located using standard methods adjusting for head size. Stimulation intensity will be at 120% of the individual’s calibrated resting motor threshold.


Locations(1)

Monash Alfred Psychiatry Research Centre - Melbourne

VIC, Australia

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ACTRN12622000909729


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