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Transcranial Magnetic Stimulation for Binge Eating Disorder

NCT ID: NCT05806944

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-15

Study Completion Date

2024-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Binge-Eating Disorder

Keywords

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Transcranial Magnetic Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

double-blinded, pseudorandomized crossover
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

Patients with BED not undergoing symptom provocation

Group Type EXPERIMENTAL

TMS followed by Sham TMS

Intervention Type DEVICE

double blinded crossover schedule in which participants will undergo TMS and assessment in one visit, followed by sham-TMS and assessment the next visit.

Group B

Patients with BED not undergoing symptom provocation

Group Type EXPERIMENTAL

Sham TMS followed by TMS

Intervention Type DEVICE

double blinded crossover schedule in which participants will undergo sham TMS and assessment in one visit, followed by TMS and assessment the next visit.

Group C

Patients with BED undergoing symptom provocation

Group Type EXPERIMENTAL

TMS followed by Sham TMS

Intervention Type DEVICE

double blinded crossover schedule in which participants will undergo TMS and assessment in one visit, followed by sham-TMS and assessment the next visit.

Group D

Patients with BED undergoing symptom provocation

Group Type EXPERIMENTAL

Sham TMS followed by TMS

Intervention Type DEVICE

double blinded crossover schedule in which participants will undergo sham TMS and assessment in one visit, followed by TMS and assessment the next visit.

Interventions

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TMS followed by Sham TMS

double blinded crossover schedule in which participants will undergo TMS and assessment in one visit, followed by sham-TMS and assessment the next visit.

Intervention Type DEVICE

Sham TMS followed by TMS

double blinded crossover schedule in which participants will undergo sham TMS and assessment in one visit, followed by TMS and assessment the next visit.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Darrin J Lee, MD, PhD

Assistant Professor of Neurological Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Darrin J Lee, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Central Contacts

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Darrin J Lee, MD PhD

Role: CONTACT

Phone: 9495220866

Email: [email protected]

Wooseong Choi, BS

Role: CONTACT

Phone: 8474017335

Email: [email protected]

Other Identifiers

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HS-21-00791

Identifier Type: -

Identifier Source: org_study_id