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Transcranial Magnetic Stimulation for Binge Eating Disorder (TMS for BED)

Primary Purpose

Binge-Eating Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TMS followed by Sham TMS
Sham TMS followed by TMS
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge-Eating Disorder focused on measuring Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Group A

    Group B

    Group C

    Group D

    Arm Description

    Patients with BED not undergoing symptom provocation

    Patients with BED not undergoing symptom provocation

    Patients with BED undergoing symptom provocation

    Patients with BED undergoing symptom provocation

    Outcomes

    Primary Outcome Measures

    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).
    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).
    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).
    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).
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    March 15, 2023
    Last Updated
    May 10, 2023
    Sponsor
    University of Southern California
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05806944
    Brief Title
    Transcranial Magnetic Stimulation for Binge Eating Disorder
    Acronym
    TMS for BED
    Official Title
    Evaluation of Active Emotional State on the Efficacy of Transcranial Magnetic Stimulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Southern California

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Binge-Eating Disorder
    Keywords
    Transcranial Magnetic Stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    double-blinded, pseudorandomized crossover
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    Patients with BED not undergoing symptom provocation
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    Patients with BED not undergoing symptom provocation
    Arm Title
    Group C
    Arm Type
    Experimental
    Arm Description
    Patients with BED undergoing symptom provocation
    Arm Title
    Group D
    Arm Type
    Experimental
    Arm Description
    Patients with BED undergoing symptom provocation
    Intervention Type
    Device
    Intervention Name(s)
    TMS followed by Sham TMS
    Intervention Description
    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
    Intervention Name(s)
    Sham TMS followed by TMS
    Intervention Description
    double blinded crossover schedule in which participants will undergo sham TMS and assessment in one visit, followed by TMS and assessment the next visit.
    Primary Outcome Measure Information:
    Title
    The effect of symptom provocation on TMS-mediated changes in the blood-oxygen-level-dependent(BOLD) signal
    Description
    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).
    Time Frame
    33 Days
    Title
    The effect of symptom provocation on TMS-mediated changes in the functional connectivity (FC) within and between pathophysiologically-relevant networks.
    Description
    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).
    Time Frame
    33 Days
    Title
    The effect of symptom provocation on TMS-mediated changes in the behavioral inhibition system (BIS)/behavioral activation system (BAS) scale score
    Description
    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).
    Time Frame
    33 Days
    Title
    The effect of symptom provocation on TMS-mediated changes in the Eating Disorder Examination - Questionnaire (EDE-Q)
    Description
    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).
    Time Frame
    33 days
    Title
    The effect of symptom provocation on TMS-mediated changes in the Eating Disorder (ED 15) questionnaire.
    Description
    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).
    Time Frame
    33 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Darrin J Lee, MD PhD
    Phone
    9495220866
    Email
    darrin.lee@med.usc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wooseong Choi, BS
    Phone
    8474017335
    Email
    wooseong@usc.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Transcranial Magnetic Stimulation for Binge Eating Disorder

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