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|NCT02232919 : Deep Brain Stimulation for Human Morbid Obesity|
|Ages||Min: 18 Years Max: 65 Years|
1. Body Mass Index [BMI] >40 kg/m2. BMI definition = weight [Kg] / height [m]2
2. Failed diet, exercise, behavior, and pharmacotherapy to control body weight.
1. 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].
2. Infectious disease [e.g., HIV or active tuberculosis].
3. 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
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
4. 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].
5. 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.
6. Lung disease:
i. Chronic obstructive airway disease or asthma requiring daily therapy. ii. Use of
7. Endocrine disease:
i. Diabetes mellitus. ii. Hyperlipidemia with triacylglycerol >500 mg/dL. iii.
Hypothyroidism, hyperthyroidism. iv. Hypopituitarism. v. Hypogonadism.
8. Psychological Disease:
i. Major clinical depression. ii. Active psychiatric disorders. iii. Schizophrenia.
9. Hematology i. Anemia [hematocrit <36.0%]. ii. Bleeding disorders, thrombocytopenia,
10. 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.
11. 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,
iv. Any other medication that, in the opinion of the investigator, may pose harm to
12. Seizure disorders.
13. Receiving anticoagulation medications or likely to need anticoagulation in the
14. Subject is not a surgical candidate.
15. Lack of social support.
16. Inability to comply with testing and follow-up visit requirements defined by the
17. Subject has another implanted device or metallic object [e.g., cardiac demand
pacemakers, aneurysm clips, cochlear implant, spinal cord stimulator, etc].
18. Subject has a medical condition that might require repeat MRIs.
19. Subject has concurrent infection.
20. Subject has any medical condition contraindicating a chronically implanted device.
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| Link to official Clinicaltrials.gov listing