Deep Brain Stimulation Effects in Patients With Chronic Refractory Obesity

NCT04453020 | Withdrawn DMC FDA Device

• 1 other identifier: Obesity IDE
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to evaluate the safety and efficacy of deep brain stimulation (DBS) of the lateral hypothalamic area (LHA) as a treatment for chronic refractory obesity. This study will include 6 individuals with chronic refractory obesity, that have failed other treatments including gastric bypass surgery.

Conditions

Obesity

Keywords

Deep Brain Stimulation; Lateral Hypothalamic Area; Feeding Behaviors; Energy Balance

Outcome Measures

Primary Outcomes (1)

• Safety - Complication Rates

  Adverse Events

  12 months

Secondary Outcomes (17)

• Resting metabolic rate (RMR)

  Baseline, 2 months, 4-5 months and 20 months post-surgery

• Energy intake

  2 months and 4-5 months post-surgery

• Impact of weight on quality of life: IWQOL-Lite

  Baseline, 2 months and 4-5 months post-surgery

• Binge Eating Scale (BES)

  Baseline, 2 months and 4-5 months post-surgery

• Yale Food Addiction Scale

  Baseline, 2 months and 4-5 months post-surgery

Study Arms (1)

LHA DBS

EXPERIMENTAL

Subjects will receive bilateral DBS of the LHA

Device: DBS of the LHA

Interventions

DBS of the LHA DEVICE

Deep Brain Stimulation of the Lateral Hypothalamic Area

Also known as: Vercise Gevia™ Deep Brain Stimulator System, Suretek Model DB-4600-C, Vercise Cartesia Directional Leads Model DB-2202-45, OR Cable and Extension Model DB-4100A, 8 Contact Extension Model NM-3138-55, Vercise Charging System Model DB-64125-US, Vercise Gevia 16 Contact IPG Kit Model DB-1200-S, Vercise DBS Remote Control 3 Kit Model DB-5552-1

LHA DBS

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients age ≥ 22 years and \< 65 years old with a BMI of ≥ 40 kg/m2.
• 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).
• Stable at their present weight (+/- 3 kg) for a 12-month period.

You may not qualify if:

• Karnofsky Performance Score \>60.
• Platelet count \>125,000 per cubic mm.
• Prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits.
• Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
• Have a history that includes a prior suicide attempt.
• Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders) or have any prior history of schizophrenia or bipolar disorder or active psychotic episodes.
• 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.
• Any current drug or alcohol abuse, per DSM-IV criteria or any history of substance abuse (alcohol or other drug) or dependence during the past 12 months.
• Any history of recurrent or unprovoked seizures.
• Any history of hemorrhagic stroke.
• Any diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
• Any diagnosis of a neurological disorder, such as multiple sclerosis, stroke, Parkinson's disease, severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
• Any history of hypothyroidism.
• Any history of demonstrated binge eating.
• Concurrent use of weight-loss prescription drug therapy or the use of over-the-counter weight loss preparations.

Sponsors & Collaborators

• donald whiting: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15229, United States

Location

MeSH Terms

Conditions

Obesity; Feeding Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Donald Whiting, MD

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: July 1, 2020
• Study Start: February 7, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

US (1)