Pilot Study to Evaluate Deep Brain Stimulation (DBS) of the Lateral Hypothalamic Area (LHA) on Energy Balance and Feeding Behavior in Patients With Chronic Refractory Obesity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- donald whiting
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Safety - Complication Rates
- Status
- Withdrawn
- Last Updated
- last year
Overview
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.
Detailed Description
Six (N = 6) subjects with chronic refractory obesity will receive bilateral DBS implants in the LHA using the Boston Scientific Vercise Gevia DBS system. The primary objective is to evaluate the safety of DBS of the LHA using the current-driven Boston Scientific device and compare that to the safety data for our previous pilot using the voltage-driven DBS system for the treatment of chronic refractory obesity. The primary efficacy objective is to determine if DBS of the LHA can affect energy balance (i.e. energy intake and/or energy expenditure) in these patients. Secondary outcomes include quality of life outcomes and changes in feeding behaviors. Study participants will undergo a two-part DBS implantation procedure for placement of DBS electrodes in the LHA. Following this procedure, subjects with complete resting metabolic rate (RMR) testing to determine the optimal settings for the LHA stimulation. If effective, DBS technology might offer severely obese adults (BMI of ≥50 kg/m2), who have failed traditional therapy, a non-destructive, adaptable, reversible neurosurgical option for altering eating habits leading to sustained weight loss in the long-term.
Investigators
donald whiting
Principal Investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Eligibility Criteria
Inclusion Criteria
- •Male and female patients age ≥ 22 years and \< 65 years old with a BMI of ≥ 40 kg/m
- •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.
- •Neuropsychiatric evaluation must not reveal any issues that will be an impediment to subject's participation (as listed in Exclusion Criteria 2, 3 and 4).
- •Karnofsky Performance Score \>
- •Platelet count \>125,000 per cubic mm.
- •Prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits.
Exclusion Criteria
- •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 ≥
- •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.
Outcomes
Primary Outcomes
Safety - Complication Rates
Time Frame: 12 months
Adverse Events
Secondary Outcomes
- 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)
- Resting metabolic rate (RMR)(Baseline, 2 months, 4-5 months and 20 months post-surgery)
- Eating inventory(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)
- Power of Food Scale(Baseline, 2 months and 4-5 months post-surgery)
- Body shape perception(Baseline, 2 months and 4-5 months post-surgery)
- Food craving inventory(Baseline, 2 months and 4-5 months post-surgery)
- Food preferences(Baseline, 2 months and 4-5 months post-surgery)
- Delayed reward discounting(Baseline, 2 months and 4-5 months post-surgery)
- Appetitive sensations(Baseline, 2 months and 4-5 months post-surgery)
- Quality of life measure: SF-36(Baseline, 2 months and 4-5 months post-surgery)
- Depression score(Baseline, 2 months and 4-5 months post-surgery)
- Changes in metabolic hormone profiles(2 months and 4-5 months post-surgery)
- Body mass index(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)
- Change in DXA body composition(2 months and 4-5 months post-surgery)