TMS for BED: Transcranial Magnetic Stimulation for Binge Eating Disorder

Sponsor

University of Southern California (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05806944

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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, The primary aim 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.

Condition or Disease	Intervention/Treatment	Phase
Binge-Eating Disorder	Device: TMS followed by Sham TMS Device: Sham TMS followed by TMS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

double-blinded, pseudorandomized crossoverdouble-blinded, pseudorandomized crossover

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Evaluation of Active Emotional State on the Efficacy of Transcranial Magnetic Stimulation

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Patients with BED not undergoing symptom provocation	Device: 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.
Experimental: Group B Patients with BED not undergoing symptom provocation	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.
Experimental: Group C Patients with BED undergoing symptom provocation	Device: 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.
Experimental: Group D Patients with BED undergoing symptom provocation	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.

Outcome Measures

Primary Outcome Measures

The effect of symptom provocation on TMS-mediated changes in the blood-oxygen-level-dependent(BOLD) signal [33 Days]
BOLD signals measure neural activity indirectly via neurovascular coupling BOLD signals before and after TMS +- symptom provocation will be compared
The effect of symptom provocation on TMS-mediated changes in the functional connectivity (FC) within and between pathophysiologically-relevant networks. [33 Days]
FC measures correlation in activity between different brain regions. FC before and after TMS +- symptom provocation will be compared
The effect of symptom provocation on TMS-mediated changes in the behavioral inhibition system (BIS)/behavioral activation system (BAS) scale score [33 Days]
BIS/BAS scale is a self reported 24 item questionnaire that assesses the BIS, a motivation system for avoiding aversive outcomes, and BAS, a motivation system for approaching goal-oriented outcomes Scores on the BIS/BAS scale before and after TMS+- symptom provocation will be compared
The effect of symptom provocation on TMS-mediated changes in the Eating Disorder Examination - Questionnaire (EDE-Q) [33 days]
The EDE-Q is a self report questionnaire of ED symptomatology over the preceding 28 days, that encompasses behavioral and attitudinal symptoms across four domains - dietary restraint, eating concern, shape concern, and weight concern Score on the EDE-Q before and after TMS +- symptom provocation will be compared
The effect of symptom provocation on TMS-mediated changes in the Eating Disorder 15 (ED 15) questionnaire. [33 days]
The ED 15 questionnaire is a measure of eating disorder symptomatology, designed to measure dynamic, session-by-session fluctuations in ED symptom severity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts 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:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Southern California

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Darrin J Lee, MD, PhD, Assistant Professor of Neurological Surgery, University of Southern California

ClinicalTrials.gov Identifier:

NCT05806944

Other Study ID Numbers:

HS-21-00791

First Posted:

Apr 10, 2023

Last Update Posted:

Apr 10, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Darrin J Lee, MD, PhD, Assistant Professor of Neurological Surgery, University of Southern California

Transcranial Magnetic Stimulation

Additional relevant MeSH terms:

Bulimia

Feeding and Eating Disorders

Binge-Eating Disorder

Study Results

No Results Posted as of Apr 10, 2023