An interventional study of TMS followed by Sham TMS and Sham TMS followed by TMS in Binge-Eating Disorder, sponsored by University of Southern California. Not yet recruiting. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
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.
233 studies on the registry are indexed under Binge-Eating Disorder; 53 are open to participants now.
This study's planned enrollment of 32 is below the median of 77 across 190 interventional studies indexed under Binge-Eating Disorder.
Browse Binge-Eating Disorder studies →University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.
Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
to receiving TMS such as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with BED not undergoing symptom provocation
Device: TMS followed by Sham TMS
Patients with BED not undergoing symptom provocation
Device: Sham TMS followed by TMS
Patients with BED undergoing symptom provocation
Device: TMS followed by Sham TMS
Patients with BED undergoing symptom provocation
Device: Sham TMS followed by 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.
double blinded crossover schedule in which participants will undergo sham TMS and assessment in one visit, followed by TMS and assessment the next visit.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 33 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2023; primary completion for Dec 2024, 12 months later.
Of 84 non-industry interventional studies with no phase under Binge-Eating Disorder, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's planned 12 months is below that.
Counting every sponsor, half of 89 studies reached it within 25 months; a quarter within 16 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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