Transcranial Magnetic Stimulation for Binge Eating Disorder

NCT05806944 | Unknown FDA Device

• 1 other identifier: HS-21-00791
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Binge-Eating Disorder

Keywords

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (5)

• The effect of symptom provocation on TMS-mediated changes in the blood-oxygen-level-dependent(BOLD) signal

  BOLD signals measure neural activity indirectly via neurovascular coupling Changes in BOLD signals from baseline after TMS +/- symptom provocation will be compared after completion of the crossover study (day 33).

  33 Days

• The effect of symptom provocation on TMS-mediated changes in the functional connectivity (FC) within and between pathophysiologically-relevant networks.

  FC measures correlation in activity between different brain regions. Changes in FC from baseline after TMS +/- symptom provocation will be compared after completion of the crossover study (day 33).

  33 Days

• The effect of symptom provocation on TMS-mediated changes in the behavioral inhibition system (BIS)/behavioral activation system (BAS) scale score

  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. The total score for BIS scale ranges from 0 to 28 (7 items ranging from 0-4). The total score for BAS ranges from 0 to 52 (13 items ranging from 0-4). Four questions are fillers. Higher score represents greater severity of symptoms. Changes in BIS/BAS scale from baseline after TMS+/- symptom provocation will be compared after completion of the crossover study (day 33).

  33 Days

• The effect of symptom provocation on TMS-mediated changes in the Eating Disorder Examination - Questionnaire (EDE-Q)

  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. The subscores are calculated as follows: Restraint = (Item 1 + Item 2 + Item 3 + Item 4 + Item 5) / 5; Eating Concern = (Item 6 + Item 7 + Item 9 + Item 15 + Item 34) / 5; Weight Concern = (Item 11 + Item 14 + Item 29 + Item 31 + Item 32) / 5; Shape Concern = (Item 10 + Item 11 + Item 12 + Item 13 + Item 30 + Item 33 + Item 35 + Item 36) / 8; Global Score = (Restraint + Eating Concern + Weight Concern + Shape Concern) / 4 Higher score represents greater severity of symptoms. Changes in the EDE-Q score from baseline after TMS +/- symptom provocation will be compared after completion of the crossover study (day 33).

  33 days

• The effect of symptom provocation on TMS-mediated changes in the Eating Disorder (ED 15) questionnaire.

  The ED 15 questionnaire is a measure of eating disorder symptomatology, designed to measure dynamic, session-by-session fluctuations in ED symptom severity. The overall score ranges from 0-6, as it is calculated as the mean of the scores on all ten items, each ranging from 0-6 on symptom severity. Higher score represents greater severity of symptoms. Changes in the ED 15 questionnaire score from baseline after TMS +/- symptom provocation will be compared after completion of the crossover study (day 33).

  33 days

Study Arms (4)

Group A

EXPERIMENTAL

Patients with BED not undergoing symptom provocation

Device: TMS followed by Sham TMS

Group B

EXPERIMENTAL

Patients with BED not undergoing symptom provocation

Device: Sham TMS followed by TMS

Group C

EXPERIMENTAL

Patients with BED undergoing symptom provocation

Device: TMS followed by Sham TMS

Group D

EXPERIMENTAL

Patients with BED undergoing symptom provocation

Device: Sham TMS followed by TMS

Interventions

TMS followed by Sham TMS 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 A; Group C

Sham TMS followed by TMS 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 B; Group D

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

MeSH Terms

Conditions

Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Darrin J Lee, MD PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darrin J Lee, MD PhD

CONTACT

9495220866; darrin.lee@med.usc.edu

Wooseong Choi, BS

CONTACT

8474017335; wooseong@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurological Surgery

Model Details: double-blinded, pseudorandomized crossover

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 10, 2023
• Study Start: December 15, 2023
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share