NCT02448836

Deep Transcranial Magnetic Stimulation (dTMS) for the Treatment of Premenstrual Dysphoric Disorder (PMDD)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Premenstrual dysphoric disorder (PMDD) is a hormone-dependent mental condition that causes significant suffering in 5% of women of reproductive age worldwide. The prominent symptoms are depressed mood, irritability, mood lability and anxiety. Treatment options for PMDD are limited, with 40% non-responders. Deep transcranial magnetic stimulation (dTMS) is a novel therapeutic technique, which is based on modulating neural activity by inducing an electric field in the brain. To date, dTMS was found to be an effective treatment for depression, which is highly comorbid with PMDD. The investigators propose to study the effect of dTMS on PMDD patients in a prospective treatment study.

Detailed description

Premenstrual dysphoric disorder (PMDD) is a hormone-dependent mental condition that causes significant distress in 5% of reproductive age women worldwide. The disorder was recently added to the diagnostic and statistical manual of mental disorders (DSM-5) as one of the mood disorders. PMDD is characterized by affective, cognitive, behavioral, and somatic symptoms. Treatment possibilities are limited, and 30-40% of patients who do not respond to antidepressants or oral contraceptives, are faced with no alternative effective treatment options. PMDD is highly comorbid with major depressive disorder (MDD) and neuroimaging studies in both disorders demonstrate dysfunction of the dorsolateral prefrontal cortex (DLPFC). Deep transcranial magnetic stimulation (dTMS) is a technique of neuromodulation based on specific anatomic induction of an electric field in the brain. To date, dTMS was proved as an effective treatment tool in a number of mental conditions including drug-resistant major depression, in which the onset of the salutary effect of dTMS was relatively quick (compared with conventional antidepressants). Most clinical trials studying the effect of dTMS in major depression, focused on stimulating the DLPFC. The investigators propose to conduct a prospective double blind cross-over study, to study the effect of short-term dTMS treatment on PMDD patients. The aim of this study is to conduct the first evaluation of deep transcranial magnetic stimulation (dTMS) as a treatment option for premenstrual dysphoric disorder (PMDD). The treatment of this recurrent episodic disorder, that effects young, reproductive-age women, poses a significant clinical challenge, as current treatment options imply reproductive impairment (oral contraceptives or GnRH (gonadotropin-releasing hormone) agonists) or disturbing side effects (e.g. sexual side effects in SSRI's (selective serotonin reuptake inhibitor)). In addition, as many as 40% of women with PMDD do not respond to conventional antidepressants or oral contraceptives, and remain without an effective and tolerable treatment option. The symptoms of PMDD are episodic and time-limited, and indeed, some of the pharmacological treatment strategies for PMDD consist of intermittent therapy. Thus, he investigators assume that dTMS administered during the 7-14 symptomatic days (after ovulation), may provide a highly needed, tolerable and efficient treatment option for women suffering from this disorder, and may actually prevent the onset of symptoms.

Conditions

• Premenstrual Dysphoric Disorder

Interventions

Type	Name	Description
DEVICE	dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coil	Patients will undergo 8 sessions of dTMS treatment for two weeks (4 sessions every week).
DEVICE	Sham: dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coil	Patients will undergo 8 sessions of Sham dTMS treatment for two weeks (4 sessions every week).

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-12-01
• First posted: 2015-05-20
• Last updated: 2015-05-20