What is the mechanism of action of this treatment?

Deep brain stimulation (DBS) of the lateral hypothalamic area (LHA) is a promising treatment for chronic refractory obesity, as it directly modulates neural activity in brain regions responsible for hunger and satiety. This method aims to correct dysfunctional neural circuits that contribute to excessive food intake and weight gain. By targeting the LHA, DBS can potentially reduce appetite and promote weight loss in patients who have not responded to conventional treatments like lifestyle changes, pharmacotherapy, or bariatric surgery. Understanding these mechanisms is crucial for developing effective interventions and providing hope for patients struggling with severe obesity.

What side effects are associated with this type of intervention?

Common treatments for obesity, particularly those involving neuromodulation like Deep Brain Stimulation (DBS), include various surgical and device-assisted procedures. Known side effects of DBS for obesity can include infection, bleeding, and hardware complications. Additionally, there may be neuropsychiatric effects such as mood changes or cognitive disturbances. Other surgical interventions like bariatric surgery can lead to nutritional deficiencies, gastrointestinal issues, and surgical complications. It is important for patients to discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for obesity, including orlistat, phentermine-topiramate, naltrexone-bupropion, and liraglutide. These medications primarily work by reducing appetite or increasing satiety. While Deep Brain Stimulation (DBS) targeting the lateral hypothalamic area is being studied as a treatment for chronic refractory obesity, it is not yet FDA-approved for this indication. DBS is a neuromodulation technique that has shown promise in other conditions like Parkinson's disease and treatment-resistant depression, suggesting potential for obesity treatment pending further research.

What other types of research exist?

Promising alternatives to Deep Brain Stimulation for obesity treatment include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing depressive symptoms and may influence weight regulation; 2) Transcranial Direct Current Stimulation (tDCS), which has been explored for its potential to modulate brain activity related to appetite and weight control; 3) Vagus Nerve Stimulation (VNS), which has been studied for its effects on appetite suppression and weight loss. These alternatives are less invasive compared to DBS and have shown potential in clinical studies.

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Device

Deep Brain Stimulation for Obesity

N/A

Recruiting

Led By Donald Whiting, MD

Research Sponsored by Donald M. Whiting, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stable at their present weight (+/- 3 kg) for a 12-month period.

Failure of bariatric surgery (gastric bypass) and subjects who have no endoscopically or surgically correctable causes for failed bariatric surgery. "Failed bariatric surgery" is determined using the modified Reinhold classification as patients who are currently more than 50% over ideal body weight at least 24 months after a technically successful surgery (as confirmed by a esophagogastroduodenoscopy (EGD) within the 6 months prior to ICF)

Must not have

Concurrent use of weight-loss prescription drug therapy or the use of over-the-counter weight loss preparations

Have a current diagnosis of major depressive episode per DSM-IV (Diagnostics and Statistical Manual of Mental Disorders) criteria or has a current BDI-II score ≥ 17

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 weeks, 2 months, 4-5 months, 6 months, 9 months, 12 months, 15 months, 18 months, 20 months and 24 months post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for people with severe obesity who haven't had success with other methods. The treatment involves placing small devices in the brain that send electrical signals to help control eating habits. The goal is to see if this can help these patients lose weight and improve their quality of life.

Who is the study for?

This trial is for adults aged 22-65 with severe obesity (BMI ≥ 50 kg/m2) who have been stable in weight for a year and whose bariatric surgery failed. They must not have any neuropsychiatric issues that could affect participation, no history of seizures or hemorrhagic stroke, and should not be at high risk of infection.

What is being tested?

The study tests the safety and effectiveness of deep brain stimulation (DBS) on the lateral hypothalamic area (LHA) in patients with chronic refractory obesity who haven't responded to other treatments including gastric bypass surgery.

What are the potential side effects?

Potential side effects may include risks associated with brain surgery such as infection, bleeding, headache, nausea, changes in mood or behavior. Specific side effects related to DBS can also occur but are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My weight has been stable, within 3 kg, for the last year.

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My weight loss surgery didn't work, and there's no surgical fix.

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I am between 22 and 65 years old with a BMI of 50 or more.

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I can care for myself but may not be able to do active work.

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My weight loss surgery didn't work, and it can't be fixed with more surgery or procedures.

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I am between 22 and 65 years old with a BMI of 50 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using prescription or over-the-counter weight loss drugs.

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I am currently diagnosed with a major depressive episode or my depression score is 17 or higher.

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I have not been diagnosed with any severe neurological disorders.

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My doctor expects I have less than a year to live due to my illness.

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I weigh less than 396 lbs and can fit into an MRI or CT scanner.

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I cannot or do not want to attend scheduled clinic visits.

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I do not have any ongoing infections, bleeding disorders, or major health risks for surgery.

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I do not plan to undergo procedures that involve sudden head or neck movements.

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I am a woman who could be pregnant, am pregnant, or am not using birth control.

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I have had brain surgery or a device implanted in my brain.

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I am taking blood thinners that can't be stopped for surgery.

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I may need treatments like cautery or radiation therapy.

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I have had seizures that happen without a known cause.

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I have had a bleeding stroke in the past.

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I have a history of hypothyroidism.

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I don't have brain conditions that prevent DBS surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 weeks, 2 months, 4-5 months, 6 months, 9 months, 12 months, 15 months, 18 months, 20 months and 24 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 weeks, 2 months, 4-5 months, 6 months, 9 months, 12 months, 15 months, 18 months, 20 months and 24 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 2 months, 4-5 months, 6 months, 9 months, 12 months, 15 months, 18 months, 20 months and 24 months post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety - Complication Rates

Secondary study objectives

Appetitive sensations

Binge Eating Scale (BES)

Body mass index

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LHA DBSExperimental Treatment1 Intervention

Subjects will receive bilateral DBS of the LHA

0 / 22Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Deep brain stimulation (DBS) of the lateral hypothalamic area (LHA) is a promising treatment for chronic refractory obesity, as it directly modulates neural activity in brain regions responsible for hunger and satiety. This method aims to correct dysfunctional neural circuits that contribute to excessive food intake and weight gain. By targeting the LHA, DBS can potentially reduce appetite and promote weight loss in patients who have not responded to conventional treatments like lifestyle changes, pharmacotherapy, or bariatric surgery. Understanding these mechanisms is crucial for developing effective interventions and providing hope for patients struggling with severe obesity.

A systematic review of body mass gain after deep brain stimulation of the subthalamic nucleus in patients with Parkinson's disease.Deep brain stimulation for treatment-resistant depression: efficacy, safety and mechanisms of action.