NCT02232919

Deep Brain Stimulation for Human Morbid Obesity

Hypothalamus Deep Brain Stimulation for Human Morbid Obesity: Feasibility Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Hospital do Coracao · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The burden of morbid obesity to the circulatory, endocrine, and locomotor systems, as well as the psychological effects and related health-care costs, are well established in the medical literature. Lifestyle and dietary patterns remain critical factors modulating long-term weight control of morbidly obese individuals (bodymass index ≥ 40). Various dietary, pharmacological, and behavioral interventions have largely failed as therapies, often necessitating surgery as the last treatment option. Long term results of bariatric surgery suggest that sustained and substantial weight loss can decrease morbidity related to obesity secondary complications such as diabetes type 2 and cancers, enhancing the role of surgery for morbidly obese subjects. However the adverse effects of bariatric surgery are considerable and impact on quality of life. Its long-term failure rates and complications call for novel and effective long-term therapies, such as neurosurgical interventions. The investigators now propose to enhance our targeting capabilities in a feasibility study of low frequency electrical stimulation using VMH-DBS (ventromedial hypothalamic) in six morbidly obese patients. After successful targeting, DBS stimulation parameters will be systematically evaluated and individually optimized at three-month intervals over a one-year stimulation period. Detailed recording of side effects, weight changes, food intake patterns, metabolic changes, and behavioral evaluations will be obtained throughout the study.

Detailed description

Neuromodulation of metabolism and feeding behavior is at hand using modern systems of deep brain stimulation (DBS). It constitutes a minimally invasive approach for these challenging patients. The surgical procedure is reversible and proven to have acceptable side effects in the frail population of Parkinson's disease patients \[Gorgulho, Hemorrhage and Infection\]. Improvement of functional stereotactic surgery methods is necessary however to the challenge of implanting DBS electrodes in the hypothalamus. Recently, a case report of a patient with DBS implanted in the hypothalamus for treatment of morbid obesity who reported side effects related to memory appeared in the literature. The authors used the side effect findings to suggest the location of their implant as a site for treatment of Alzheimer's disease. This illustrates the need of betterment of our techniques of targeting in DBS surgery, especially for targets located in highly functional structures, such as the hypothalamus.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation	If subjects qualify with respect to protocol requirements, the Medtronic Activa system will be implanted with the leads placed bilaterally in the VMH. Adjustment of DBS parameters at the three months visit will be performed to improve efficacy when the goal of 3% body weight loss mark was not achieved during this period of continuous stimulation. Subjects will be seen monthly after discharge throughout the study period. At visits, safety will be assessed through blood/urine tests, blood pressure measurements, verbal interviews with the subjects and family, quarterly formal psychiatric tests as well as QOL scales. The determination of efficacy will be the within-group percent change in weight at the end of the DBS treatment period compared to baseline.

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-09-05
• Last updated: 2016-09-29

Locations

1 site across 1 country: Brazil