Deep Brain Stimulation Effects on Weight Change and Metabolic Rate

Study Overview
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Brief Summary
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This study focuses on lateral hypothalamic area (LHA) deep brain stimulation (DBS) for severe obesity. In a previous pilot study, three subjects were implanted with a DBS electrode into the LHA under an Investigational Device Exemption (IDE) and IRB approved study at West Virginia University. That study demonstrated the safety of DBS of the LHA in these patients. These patients, who met the enrollment criteria of having prior placement of LHA DBS in accordance with previous study protocol, were eligible for this study with a goal of determining optimal DBS settings.

Detailed Description
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The goal of this study was to investigate changes in Resting Metabolic Rate (RMR) at different settings during stimulation of the LHA with DBS and to find the optimal setting for increasing the RMR in two patients that previously were implanted. Although 3 subjects had undergone placement of the DBS electrode in the pilot study, one subject was withdrawn from this study due to a lead breakage and medical instability pertaining to an unrelated abdominal infection. Each subject utilized the metabolic chambers and Deltatrac II Metabolic Carts (SensorMedics Corporation, Anaheim, California or Datex-Ohmeda, Helsinki, Finland) at Pennington Biomedical Research Center (PBRC), in Baton Rouge, Louisiana to objectively measure the correlation of their metabolic rate to various novel settings on the DBS for a one week period. The schedule for the metabolic testing included: Day 0 baseline overnight chamber with no stimulation. Days 1-4 Resting metabolic rate (RMR) will be performed hourly with variable LHS DBS settings. The settings will be changed approximately every 15 minutes after the DBS settings are changed. Day 4 overnight chamber at ideal metabolic rate setting. After RMR test on Day 4, the subject will have a dual-energy x-ray absorptiometry (DXA) scan performed to assess body composition. Subjects were also be seen in clinic as often as every month but no less than every 3 months to assess changes in weight until the study ended.

Official Title
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Effects of Deep Brain Stimulation of the Lateral Hypothalamic Area on Weight Change and Metabolic Rate

Conditions
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Obesity

Intervention / Treatment
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* Device: Deep Brain Stimulation of the Lateral Hypothalamic Area


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior placement of LHA DBS in accordance with previous study protocol Exclusion Criteria: Not a participant of the original LHA DBS study Prior brain surgery, excluding the placement of LHA DBS Taking medications with a recognized adverse event of weight change. Diagnosis of a neurological disorder, such as multiple sclerosis or stroke. Concurrent use of weight-loss prescription drug therapy or the use of over- the-counter weight loss preparations. Unable to participate in scheduled study visits
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBS of the Lateral Hypothalamic Area<br>Single Arm: Deep Brain Stimulation of LHA for maximum RMR On days 1-4, subjects stayed in the inpatient unit to have metabolic weight, temperature, and resting metabolic rate (RMR) measured at different settings. Metabolic testing RMR measurement: A clear plastic hood was placed over the head and chest Oxygen intake and carbon dioxide out-put were measured to determine how many calories were burned during the next 15-30 minutes. Each hour for the next seven hours, DBS settings were changed and the above process was repeated. On Day 4, a DXA scan was performed to assess body composition. Primary endpoint is the determination of optimal settings | Device: Deep Brain Stimulation of the Lateral Hypothalamic Area<br>* Deep Brain Stimulation of the Lateral Hypothalamic Area<br>* Other names: Medtronic Extension model # 37086-60;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Metabolic Rate | Metabolic rate of subjects will be measured while at Pennington Biomedical Research Center. Percentage of change in these parameters will be measured. | One week of testing for each subject. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Deep Brain Stimulation, LHA