Binge-Eating DisorderNCT07907328
FUS Neuromodulation for Binge Eating Disorder
A study testing LIFU Neuromodulation in people with Binge-Eating Disorder, run by Ali Rezai at 1 site in United States.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- LIFU Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
A candidate will be eligible if they meet all the following criteria:
- Age 18-80 years at time of enrollment.
- Diagnosis of moderate to extreme binge eating disorder (BED) per DSM-5-TR criteria
- Participant is able and willing to give informed consent.
- Participant is willing to cooperate with the study requirements, including compliance with the regimen, completion of all study visits, and study assessments.
- Participants of reproductive potential must have negative pregnancy test and agree to use acceptable forms of contraception.
- Participant able to communicate sensations during the procedure.
A candidate will be excluded if they meet any of the following criteria:
- Unable to undergo MR-imaging or clinically significant MRI findings
- History of any clinically significant neurological disorder.
- Evidence of substance (alcohol or other drug) use disorder during the previous 12 months .
- Past or present diagnosis of psychotic disorder or bipolar disorder
- Currently taking opioid pain medications or positive drug screen for opiates.
- If participants are on medication for the treatment of binge eating disorder or obesity (they must be on a stable dose for at least one month and agree to not begin a medication until after their Week 12 visit.
- Subject has a lifetime history or current symptoms consistent with bulimia nervosa or anorexia nervosa .
- Have a recorded or self-reported change in body weight >11 lbs. within 3 months prior to screening
- Have a prior or planned surgical treatment for obesity (excluding lap-band if removed >6 months prior to screening or liposuction or abdominoplasty if performed >1 year prior to screening)
- Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening
- History of medically verified suicide attempt within the past year. Clinically significant suicide risk
- Participant who is currently participating in another clinical investigation with an active treatment arm.
- Participant is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator.
- Participant is pregnant/ lactating or planning to be pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
West Virginia University: Rockefeller Neuroscience Institute
Morgantown, West Virginia, 26506
Study Coordinator, 304-293-0930, tldeal@hsc.wvu.edu
About this study
Official title: Early Feasibility Study of Focused Ultrasound (FUS) Neuromodulation in Patients With Binge Eating Disorder
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)
Read the detailed description
The primary objective is to evaluate the safety, feasibility and tolerability of FUS as an adjunct neuromodulatory treatment for BED
- Conditions
- Binge-Eating Disorder
- Being tested
- LIFU Neuromodulation
- Keywords
- Neuromdulation, Focused Ultrasound
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFU NeuromodulationDevice
Subjects will undergo a single LIFU of the target brain region
| Study group | Role | What they receive |
|---|---|---|
| FUS Neuromodulation | Experimental | Not described Receives: Device: LIFU Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment Emergent Adverse Events
All adverse events that are related to FUS procedure will be assessed
Measured: baseline compared to 4 and 12 weeks after study procedure
Secondary outcomes (3)
Change in Food craving
Visual Analog scale
Measured: 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),
Measured: 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
Measured: Week 4 and 12 comparisons will be made relative to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startNov 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ali Rezai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Rezai, West Virginia University
- Investigators
- Ali Rezai, Principal investigator, WVU Rockefeller Neuroscience Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907328
- Sponsor's protocol ID
- FUS_NMD_BED02
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of Focused Ultrasound (FUS) Neuromodulation in Patients With Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT07907328
- Acronym / sponsor ID
- FUS_NMD_BED02
- Conditions
- Binge-Eating Disorder
- Keywords
- Neuromdulation, Focused Ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ali RezaiUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
The primary objective is to evaluate the safety, feasibility and tolerability of FUS as an adjunct neuromodulatory treatment for BED
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FUS Neuromodulation | Experimental | Device: LIFU Neuromodulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIFU NeuromodulationSubjects will undergo a single LIFU of the target brain region | Device | FUS Neuromodulation |
Primary outcome
Occurrence of Treatment Emergent Adverse Events
Time frame: baseline compared to 4 and 12 weeks after study procedure
All adverse events that are related to FUS procedure will be assessed
3 secondary outcomes
Change in Food craving
Time frame: Week 4 and 12 comparisons will be made relative to baseline
Change in Eating behavior
Time frame: Week 4 and 12 comparisons will be made relative to baseline
change in eating Behavior
Time frame: Week 4 and 12 comparisons will be made relative to baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
Not yet recruiting
Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online)
Binge Eating, Overweight and Obesity
Active, not recruitingEarly Phase 1
Naltrexone Neuroimaging in Teens With Eating Disorders
Eating Disorders, Binge Eating
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Rezai principal investigator
WVU Rockefeller Neuroscience Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIFU Neuromodulation in people with Binge-Eating Disorder, run by Ali Rezai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Marton (304-293-5886, jmarton@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment Emergent Adverse Events (time frame: baseline compared to 4 and 12 weeks after study procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.