Deep Brain Stimulation Effects in Patients With Chronic Refractory Obesity (NCT04453020) | Clinical Trial Compass
WithdrawnNot Applicable
Deep Brain Stimulation Effects in Patients With Chronic Refractory Obesity
Stopped: The advent of GLP-1 medications for obesity has hampered successful recruitment. No subjects were consented nor enrolled into this study since the start date.
United States0Started 2022-02-07
Plain-language 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.
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.