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

Trial Summary

What is the purpose of this trial?

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)

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 data supports the effectiveness of the treatment Low Intensity Focused Ultrasound (LIFU) for Binge Eating Disorder?

Research on non-invasive brain stimulation (NIBS), which includes techniques similar to LIFU, shows promise in treating eating disorders by altering brain activity related to food cravings and consumption. Studies suggest that targeting specific brain areas can help improve control over eating behaviors, which may be beneficial for conditions like binge eating disorder. ^{1 2 3 4 5}

Is focused ultrasound safe for humans?

The research articles reviewed do not provide specific safety data for focused ultrasound or its variants like Low Intensity Focused Ultrasound (LIFU) in humans. They focus on other non-invasive brain stimulation methods, such as transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), which are generally considered safe when used properly. ^{1 4 5 6 7}

How is Low Intensity Focused Ultrasound (LIFU) treatment different from other treatments 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 of the brain, unlike traditional treatments that may involve medication or behavioral therapy. This approach is part of a broader category called non-invasive brain stimulation, which is being explored for its potential to modulate brain activity related to eating behaviors. ^{1 8 9 10 11}

Research Team

Ali Rezai

Principal Investigator

WVU Rockefeller Neuroscience Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: LIFU Neuromodulation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Ali Rezai

Lead Sponsor

Trials

6

Recruited

90+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Neuromodulation and Eating Disorders. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Neuromodulation and neurofeedback treatments in eating disorders and obesity. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Targeting Neural Endophenotypes of Eating Disorders with Non-invasive Brain Stimulation. [2020]

5. Switzerland 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Predictors of neurofeedback treatment outcome in binge-eating disorder: An exploratory study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Near-infrared spectroscopy and electroencephalography neurofeedback for binge-eating disorder: an exploratory randomized trial. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

[Non-Invasive Brain Stimulation in the Treatment of Eating Disorders - A Narrative Review]. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Neurofeedback strategies in binge-eating disorder as predictors of EEG-neurofeedback regulation success. [2023]

10. Switzerland 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. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Nucleus accumbens deep brain stimulation in a rat model of binge eating. [2018]