Clinical trial NCT05806944: Transcranial Magnetic Stimulation for Binge Eating Disorder
Official title: Evaluation of Active Emotional State on the Efficacy of Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Binge-Eating Disorder
Keywords: Transcranial Magnetic Stimulation
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: double-blinded, pseudorandomized crossover
Primary purpose: TREATMENT

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.

Detailed 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.

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:

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

Primary outcomes:
measure: The effect of symptom provocation on TMS-mediated changes in the blood-oxygen-level-dependent(BOLD) signal
timeFrame: 33 Days
measure: The effect of symptom provocation on TMS-mediated changes in the functional connectivity (FC) within and between pathophysiologically-relevant networks.
timeFrame: 33 Days
measure: The effect of symptom provocation on TMS-mediated changes in the behavioral inhibition system (BIS)/behavioral activation system (BAS) scale score
timeFrame: 33 Days
measure: The effect of symptom provocation on TMS-mediated changes in the Eating Disorder Examination - Questionnaire (EDE-Q)
timeFrame: 33 days
measure: The effect of symptom provocation on TMS-mediated changes in the Eating Disorder (ED 15) questionnaire.
timeFrame: 33 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Southern California
name: Darrin J Lee, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: