An interventional study of LIFU Neuromodulation in Binge-Eating Disorder, sponsored by Ali Rezai. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Ali Rezai · Not applicable, Interventional, and Treatment
This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of FUS neuromodulation in patients with Binge Eating Disorder (BED)
The primary objective is to evaluate the safety, feasibility and tolerability of FUS as an adjunct neuromodulatory treatment for BED
233 studies on the registry are indexed under Binge-Eating Disorder; 53 are open to participants now.
This study's planned enrollment of 15 is below the median of 77 across 190 interventional studies indexed under Binge-Eating Disorder.
Browse Binge-Eating Disorder studies →Ali Rezai is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
A candidate will be eligible if they meet all the following criteria:
A candidate will be excluded if they meet any of the following criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: LIFU Neuromodulation
Subjects will undergo a single LIFU of the target brain region
Occurrence of Treatment Emergent Adverse Events
All adverse events that are related to FUS procedure will be assessed
Time frame: baseline compared to 4 and 12 weeks after study procedure
Change in Food craving
Visual Analog scale
Time frame: Week 4 and 12 comparisons will be made relative to baseline
Change in Eating behavior
As measured by self-report binge eating, the Eating Disorder Examination-Interview (EDE-I),
Time frame: Week 4 and 12 comparisons will be made relative to baseline
change in eating Behavior
As measured by self-report binge eating Eating Disorder Examination Questionnaire EDE\_Q
Time frame: Week 4 and 12 comparisons will be made relative to baseline
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 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 24 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Ali Rezai