Binge-Eating DisorderNCT06485687
Low Intensity Focused Ultrasound 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 LIFU for neuromodulation in patients with Binge Eating Disorder (BED) Read more about this study
- Who is it for?
- Ages 22 to 65 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
- 31 Oct 2024to 31 Dec 2027
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and non-pregnant females, 22 - 65 years of age.
- Participant meets DSM-5 criteria for moderate to extreme BED.
- Weight ≤450lb to accommodate in MRI.
- Shoulder width of ≤65 inches to accommodate in MRI.
- The neuromodulation targets are visible on MRI for target selection.
- Participant is able and willing to give informed consent.
Who cannot join
- Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia).
- Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
- Participants with known untreated or unstable cardiac status or hypertension
- Evidence of substance (alcohol or other drug) use disorder during the previous 12 months (assessed via SCID-5).
- Past or present diagnosis of schizophrenia, psychotic disorder or bipolar disorder (assessed via SCID-5)
- Participant who is currently participating in another clinical investigation with an active treatment arm.
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- Use of any medications that, in the opinion of the Investigator, may put the participant at higher risk for AEs, or impair the participant's ability to perform complete study procedures.
- 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.
United States1 site
West Virginia University: Rockefeller Neuroscience Institute
Morgantown, West Virginia, 26506
About this study
Official title: Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Binge Eating Disorder (BED)
This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with Binge Eating Disorder (BED)
Read the detailed description
The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for BED
- Conditions
- Binge-Eating Disorder
- Being tested
- LIFU Neuromodulation
- 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 |
|---|---|---|
| LIFU 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 LIFU procedure will be assessed
Measured: [baseline and day 7 and 90 after study procedure
Secondary outcomes (1)
Effect of LIFU on Food craving
Visual Analog scale and food diary
Measured: Day 1, Day 7, Day 30, Day 60, Day 90; comparisons will be made relative to baseline, pre-LIFU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start31 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (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
- NCT06485687
- Sponsor's protocol ID
- RNI_NMD_BED01
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Binge Eating Disorder (BED)
- ClinicalTrials.gov ID
- NCT06485687
- Acronym / sponsor ID
- RNI_NMD_BED01
- Conditions
- Binge-Eating Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ali RezaiUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Jul 2024 (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 LIFU for neuromodulation in patients with Binge Eating Disorder (BED)
Detailed description
The primary objective is to evaluate the safety, feasibility and tolerability of LIFU 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 |
|---|---|---|
| LIFU Neuromodulation | Experimental | Device: LIFU Neuromodulation |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and non-pregnant females, 22 - 65 years of age.
- Participant meets DSM-5 criteria for moderate to extreme BED.
- Weight ≤450lb to accommodate in MRI.
- Shoulder width of ≤65 inches to accommodate in MRI.
- The neuromodulation targets are visible on MRI for target selection.
Key exclusion criteria (9 listed)
- Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia).
- Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
- Participants with known untreated or unstable cardiac status or hypertension
- Evidence of substance (alcohol or other drug) use disorder during the previous 12 months (assessed via SCID-5).
- Past or present diagnosis of schizophrenia, psychotic disorder or bipolar disorder (assessed via SCID-5)
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 | LIFU Neuromodulation |
Primary outcome
Occurrence of Treatment Emergent Adverse Events
Time frame: [baseline and day 7 and 90 after study procedure
All adverse events that are related to LIFU procedure will be assessed
1 secondary outcome
Effect of LIFU on Food craving
Time frame: Day 1, Day 7, Day 30, Day 60, Day 90; comparisons will be made relative to baseline, pre-LIFU.
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 18 Dec 2025.
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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. This study is not recruiting at the moment.
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?
The sponsor lists 6 inclusion and 9 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment Emergent Adverse Events (time frame: [baseline and day 7 and 90 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 18 Dec 2025.