Transcranial Magnetic Stimulation for Binge Eating Disorder

University of Southern California

Status: Not yet enrolling

Conditions: Binge-Eating Disorder

Treatments: Device: TMS followed by Sham TMS; Device: Sham TMS followed by TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT05806944

HS-21-00791

Details and patient eligibility

About

The primary goal of this study is to elucidate the impact of disorder provocation on the efficacy of TMS for the treatment of BED. In order to meet this objective, the investigators propose to evaluate this relationship in using a crossover study. Secondary objectives of this study include determining whether TMS with or without BED symptom provocation has effects in altering neurophysiology as detected by fMRI.

Full description

Current literature has demonstrated that transcranial magnetic stimulation (TMS) targeting the dorsolateral prefrontal cortex (DLPFC) has some efficacy in treating binge eating disorder. The investigators believe that TMS may be beneficial in the treatment of binge eating disorder. The purpose of this study is to determine whether TMS has efficacy for binge eating disorder and if symptom provocation affects treatment. This study will be conducted as a pilot study in the Keck Hospital clinics. 32 adult patients with a clinical diagnosis of binge eating disorder will be recruited.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English speaking (EPSI and Binge Eating Disorder Scale available only in English)
• Diagnosed with binge eating disorder as defined by the DSM-5 and in treatment for at least 6 months
• Stable doses of medications for at least 6 weeks
• Female subjects of childbearing age must consent to pregnancy tests at the beginning of each treatment session; will be counseled to use barrier methods during the course of this study

Exclusion criteria

Contraindications to receiving TMS such as:

1. Aneurysm clips or coils
2. Stents in the neck or brain
3. Deep brain stimulators
4. Electrodes to monitor brain activity
5. Metallic implants in ears and eyes
6. Shrapnel or bullet fragments in or near the head
7. Facial tattoos with metallic or magnetic-sensitive ink
8. Other metal devices or object implanted in or near the head

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 4 patient groups

Group A

Experimental group

Description:

Patients with BED not undergoing symptom provocation

Treatment:

Device: TMS followed by Sham TMS

Group B

Experimental group

Description:

Patients with BED not undergoing symptom provocation

Treatment:

Device: Sham TMS followed by TMS

Group C

Experimental group

Description:

Patients with BED undergoing symptom provocation

Treatment:

Device: TMS followed by Sham TMS

Group D

Experimental group

Description:

Patients with BED undergoing symptom provocation

Treatment:

Device: Sham TMS followed by TMS