Status:
COMPLETED
Deep Brain Stimulation for Human Morbid Obesity
Lead Sponsor:
Hospital do Coracao
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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. L...
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 sur...
Eligibility Criteria
Inclusion
- Body Mass Index \[BMI\] \>40 kg/m2. BMI definition = weight \[Kg\] / height \[m\]2
- Failed diet, exercise, behavior, and pharmacotherapy to control body weight.
Exclusion
- Cancer requiring treatment in the past five years, with the exception of cancers which have been cured or, in the opinion of the investigator, carry a good prognosis \[for example, non melanoma skin cancer\].
- Infectious disease \[e.g., HIV or active tuberculosis\].
- Cardiovascular disease:
- i. Hospitalization for treatment of heart disease in the past 6 months. ii. New York Heart Association Functional Class \>2. iii. Left bundle branch block on EKG. iv. Third degree atrioventricular block on EKG. v. Uncontrolled hypertension \[average systolic blood pressure of \>160 mmHg or diastolic blood pressure \>95 mmHg on both screening visits\].
- vi. Pulse rate \>95 beats per minute on both screening visits. vii. Total serum cholesterol \>300 mg/dL. viii. Stroke or transient ischemic attack in the past 6 months.
- Gastrointestinal disease:
- i. Chronic hepatitis or cirrhosis. ii. Episode of alcoholic hepatitis or alcoholic pancreatitis. iii. Inflammatory bowel disease requiring treatment in the past year. iv. Recent or significant abdominal surgery \[e.g., gastrectomy or gastric bypass\].
- Renal disease:
- i. Serum creatinine \>1.5 mg/dL. ii. Urine protein\>2+ on dipstick at screening and or 24-hour urinary excretion of albumin\>500 mg/day.
- Lung disease:
- i. Chronic obstructive airway disease or asthma requiring daily therapy. ii. Use of home oxygen.
- Endocrine disease:
- i. Diabetes mellitus. ii. Hyperlipidemia with triacylglycerol \>500 mg/dL. iii. Hypothyroidism, hyperthyroidism. iv. Hypopituitarism. v. Hypogonadism.
- Psychological Disease:
- i. Major clinical depression. ii. Active psychiatric disorders. iii. Schizophrenia.
- Hematology i. Anemia \[hematocrit \<36.0%\]. ii. Bleeding disorders, thrombocytopenia, thrombocytosis.
- Conditions or behaviors likely to affect the conduct of the study:
- i. Unable or unwilling to give informed consent. ii. Unable to communicate with the clinic staff. iii. Weight loss \>10% in the past 6 months. iv. Unable to walk 0.25 miles in 10 minutes. v. Behavioral disorder which, in the opinion of the investigator, would impede conduct of the study.
- vi. Excessive alcohol intake, use of illicit drugs.
- Conditions related to medications:
- i. Psychoactive agents. ii. Monoamine oxidase inhibitors \[e.g., phenelzine, procarbazine, selegiline, furazolidone\].
- iii. Antidepressants \[e.g., lithium, fluoxetine, sertraline, nefazodone, paroxetine, venlafaxine\].
- iv. Any other medication that, in the opinion of the investigator, may pose harm to the subject.
- Seizure disorders.
- Receiving anticoagulation medications or likely to need anticoagulation in the foreseeable future.
- Subject is not a surgical candidate.
- Lack of social support.
- Inability to comply with testing and follow-up visit requirements defined by the Study Protocol.
- Subject has another implanted device or metallic object \[e.g., cardiac demand pacemakers, aneurysm clips, cochlear implant, spinal cord stimulator, etc\].
- Subject has a medical condition that might require repeat MRIs.
- Subject has concurrent infection.
- Subject has any medical condition contraindicating a chronically implanted device.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02232919
Start Date
April 1 2014
End Date
April 1 2016
Last Update
September 29 2016
Active Locations (1)
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1
Hospital do Coracao
São Paulo, São Paulo, Brazil, 04005-000