Deep Brain Stimulation for Human Morbid Obesity
Condition: Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Deep Brain Stimulation
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Deep Brain Stimulation