Focused Ultrasound for Binge Eating Disorder

Overseen By Victor Finomore

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ali Rezai

Disqualifiers: Substance use disorder, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 1 day

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for Binge Eating Disorder (BED) using Low Intensity Focused Ultrasound (LIFU). The goal is to determine if this approach is safe and tolerable when influencing brain activity in individuals with BED. The study seeks participants diagnosed with moderate to extreme BED who can comfortably undergo an MRI scan. Participants should not have metallic implants, severe skin conditions on the head, or certain mental health disorders. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in BED treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that if any medications may put you at higher risk or affect your ability to complete the study, you might not be eligible. It's best to discuss your specific medications with the study team.

What prior data suggests that this technique is safe for neuromodulation in patients with Binge Eating Disorder?

Earlier studies have examined Low Intensity Focused Ultrasound (LIFU) for its safety and potential benefits in treating anxiety and depression. However, solid information about LIFU's safety for people remains limited. Researchers do not yet fully understand how well people can tolerate it or what side effects might occur. As this study is in an early stage, it primarily aims to determine LIFU's safety and how people respond to it. This type of study typically indicates that the treatment is still undergoing safety testing in humans. So far, no major side effects have been reported, but further research is necessary to confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for binge eating disorder, which often include medications like antidepressants or cognitive behavioral therapy, Low Intensity Focused Ultrasound (LIFU) offers a non-invasive neuromodulation approach. LIFU targets specific areas of the brain to potentially alter its activity without surgery or medication. Researchers are excited about LIFU because it could provide a precise and adjustable treatment option with fewer side effects, offering hope for those who haven't responded well to existing therapies.

What evidence suggests that Low Intensity Focused Ultrasound is effective for Binge Eating Disorder?

Research shows that Low Intensity Focused Ultrasound (LIFU), the treatment under study in this trial, may help people with Binge Eating Disorder (BED). LIFU uses sound waves to target specific brain areas that control eating habits. Early results suggest this non-invasive method might alter the function of these brain regions, potentially reducing binge eating episodes. Although human studies provide limited data, initial research is promising. It indicates that LIFU might influence brain circuits related to impulse control and reward, which are often overactive in BED. These early findings offer hope for its effectiveness in managing the disorder, but further research is needed to confirm these results. ^{1 3 5 6 7}

Who Is on the Research Team?

Ali Rezai

Principal Investigator

WVU Rockefeller Neuroscience Institute

Are You a Good Fit for This Trial?

This trial is for men and women aged 22-60 who have moderate to extreme Binge Eating Disorder (BED) as defined by DSM-5. Participants must weigh less than or equal to 450 pounds, have a shoulder width of ≤65 inches to fit in an MRI machine, and their neuromodulation targets must be visible on MRI.

Inclusion Criteria

Males and non-pregnant females, 22 - 60 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LIFU neuromodulation treatment for Binge Eating Disorder

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Visits on Day 7, Day 30, Day 60, and Day 90

What Are the Treatments Tested in This Trial?

Interventions

• Low Intensity Focused Ultrasound

Trial Overview The study tests the safety and tolerability of Low Intensity Focused Ultrasound (LIFU) for neuromodulation in patients with BED. It's an early-stage, single-center trial where all participants receive the same treatment without a comparison group.

How Is the Trial Designed?

Group I: LIFU Neuromodulation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Ali Rezai

Lead Sponsor

Trials

6

Recruited

90+

Published Research Related to This Trial

Non-invasive brain stimulation (NIBS), especially repetitive transcranial magnetic stimulation (rTMS), has been shown to effectively reduce food cravings in both single-session and multi-session formats, with more consistent results compared to transcranial direct current stimulation (tDCS).

While preliminary findings suggest potential benefits of NIBS for treating obesity and eating disorders, more research is needed to confirm these effects, particularly for conditions like bulimia and binge eating disorder, and caution is advised when considering NIBS for anorexia due to possible adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive brain stimulation for food cravings, consumption, and disorders of eating: A review of methods, findings and controversies. Hall, PA., Vincent, CM., Burhan, AM.[2018]

Non-invasive brain stimulation (NIBS) techniques like rTMS and tDCS may offer promising treatment options for eating disorders (ED) by targeting specific neural substrates related to behaviors such as reward processing and cognitive control.

The review emphasizes the importance of selecting appropriate brain targets for NIBS based on the Research Domain Criteria (RDoC) framework, which could enhance treatment efficacy by focusing on the underlying neurobiological and behavioral dimensions of ED rather than just traditional diagnostic criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Neural Endophenotypes of Eating Disorders with Non-invasive Brain Stimulation. Dunlop, KA., Woodside, B., Downar, J.[2020]

In a study involving 23 adults with binge-eating disorder (BED), specific mental strategies like 'Imagination,' 'Behavior,' and 'Thought' were found to positively influence the success of neurofeedback (NF) treatment aimed at reducing problematic brain activity.

The research identified a classification system for mental strategies that can help in regulating food-related responses, suggesting that certain strategies may be more effective than others in managing BED and could be useful beyond the NF treatment context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback strategies in binge-eating disorder as predictors of EEG-neurofeedback regulation success. Wimmer, J., Rösch, SA., Schmidt, R., et al.[2023]

High-frequency deep brain stimulation (DBS) in the nucleus accumbens (NAc) core significantly reduced binge eating sizes in a chronic binge eating model using 18 male Sprague-Dawley rats.

However, the same stimulation did not show a significant effect during relapse to binge eating, indicating that while DBS can help in the initial treatment, its effectiveness may vary during relapse situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nucleus accumbens deep brain stimulation in a rat model of binge eating. Doucette, WT., Khokhar, JY., Green, AI.[2018]

The study demonstrated the feasibility of using real-time functional near-infrared spectroscopy (rtfNIRS) and electroencephalography (EEG) neurofeedback (NF) in treating binge-eating disorder (BED) with 72 participants over 8 weeks, showing good recruitment and adherence rates.

While binge-eating frequency improved by an average of 8 episodes post-treatment, there was no significant difference between the NF groups and the waitlist control, although NF showed benefits in reducing food cravings, anxiety symptoms, and body mass index.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Near-infrared spectroscopy and electroencephalography neurofeedback for binge-eating disorder: an exploratory randomized trial. Hilbert, A., Rösch, SA., Petroff, D., et al.[2023]

Recent studies, including seven randomized controlled trials and case series, suggest that noninvasive brain stimulation (NIBS) and neurofeedback may be promising treatments for eating disorders and obesity, although one NIBS trial did not yield positive results.

Deep brain stimulation (DBS) has shown potential in treating anorexia nervosa, indicating that neuromodulation techniques are gaining traction as experimental interventions in the field of eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation and neurofeedback treatments in eating disorders and obesity. Dalton, B., Campbell, IC., Schmidt, U.[2022]

In a clinical study involving six patients with treatment-resistant depressive episodes, accelerated intermittent Theta Burst Stimulation (iTBS) was well-tolerated and led to complete remission of binge eating episodes in two women with comorbid Bipolar Disorder Type II and Binge Eating Disorder (BED).

The improvement in BED symptoms persisted for up to 12 weeks after the iTBS treatment, suggesting that neuromodulation may be a promising approach for treating BED, although further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Repeated Transcranial Magnetic Stimulation Improves Comorbid Binge Eating Disorder in Two Female Patients With Treatment-Resistant Bipolar Depression. Sciortino, D., Schiena, G., Cantù, F., et al.[2021]

In a study of 78 patients with binge-eating disorder (BED) undergoing neurofeedback treatment, higher levels of eating disorder psychopathology, food cravings, and body mass index (BMI) were linked to worse treatment outcomes, indicating that these factors should be considered when predicting success in neurofeedback therapy.

The study suggests that while eating disorder-related predictors significantly influenced treatment success, general psychopathology factors like anxiety and depression did not show a similar predictive value, highlighting the need for tailored approaches in neurofeedback treatment for BED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of neurofeedback treatment outcome in binge-eating disorder: An exploratory study. Rösch, SA., Schmidt, R., Hilbert, A.[2023]

Recent evidence suggests that neuromodulation techniques, particularly rTMS and DBS, show therapeutic potential and safety in treating severe cases of anorexia nervosa, although most studies are limited to small trials and case reports.

There is a need for high-quality clinical trials to explore various neuromodulation methods and their mechanisms of action across different eating disorder populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation and Eating Disorders. Gallop, L., Flynn, M., Campbell, IC., et al.[2023]

Non-invasive brain stimulation (NIBS) is emerging as a promising innovative treatment for eating disorders (ED), with some studies indicating it may help reduce symptoms like food cravings and restrictive eating.

A review of 32 articles identified only 9 empirical studies on NIBS in ED patients, highlighting the need for more rigorous research to establish consistent efficacy and treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Non-Invasive Brain Stimulation in the Treatment of Eating Disorders - A Narrative Review]. Schag, K., İnce, B., Zipfel, S., et al.[2022]

A study involving 41 adults with binge eating disorder (BED) showed that combining inhibitory control training with transcranial direct current stimulation (tDCS) significantly reduced binge eating episodes, with the frequency dropping from 18.6 to 4.4 episodes after treatment.

The results indicate that this combined approach is safe and effective, with sustained improvements observed even 12 weeks after treatment, suggesting it could be a promising intervention for BED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibitory Control Training Enhanced by Transcranial Direct Current Stimulation to Reduce Binge Eating Episodes: Findings from the Randomized Phase II ACCElect Trial. Giel, KE., Schag, K., Max, SM., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06485687

Low Intensity Focused Ultrasound for Binge Eating Disorder It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. withpower.com withpower.com/trial/phase-binge-eating-disorder-9-2024-a603c

Focused Ultrasound for Binge Eating Disorder Low Intensity Focused Ultrasound (LIFU) is a unique treatment for binge eating disorder because it uses sound waves to non-invasively stimulate specific areas ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11700779/

A Comprehensive Review of Low-Intensity Focused ... In this study, we provide a review of the most recent LIFU literature covering three key domains: 1) the history of focused ultrasound ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06485687/low-intensity-focused-ultrasound-for-binge-eating-disorder

Low Intensity Focused Ultrasound for Binge Eating Disorder This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients ...

5. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2025.1478534/full

Investigating low intensity focused ultrasound pulsation in ... This double-blinded, sham-controlled study aims to investigate the effects of LIFUP to the left caudate head and right nucleus accumbens in participants with ...

6. fusfoundation.org fusfoundation.org/posts/clinical-trial-investigates-low-intensity-focused-ultrasound-for-depression/

Clinical Trial Investigates Low-Intensity ... A clinical trial is investigating the safety and feasibility of using low-intensity focused ultrasound to address anxiety and depression.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X23017643

Neuroethical implications of focused ultrasound for ... MR-guided focused ultrasound is a promising intervention for treatment-resistant mental illness, and merits contextualized ethical exploration.