Deep Brain Stimulation Effects in Patients With Chronic Refractory Obesity
Deep Brain Stimulation Effects in Patients With Chronic Refractory Obesity
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.
Six (N = 6) subjects with chronic refractory obesity will receive bilateral DBS implants in
 the LHA using the Boston Scientific Vercise Gevia DBS system. The primary objective is to
 evaluate the safety of DBS of the LHA using the current-driven Boston Scientific device and
 compare that to the safety data for our previous pilot using the voltage-driven DBS system
 for the treatment of chronic refractory obesity. The primary efficacy objective is to
 determine if DBS of the LHA can affect energy balance (i.e. energy intake and/or energy
 expenditure) in these patients. Secondary outcomes include quality of life outcomes and
 changes in feeding behaviors. Study participants will undergo a two-part DBS implantation
 procedure for placement of DBS electrodes in the LHA. Following this procedure, subjects with
 complete resting metabolic rate (RMR) testing to determine the optimal settings for the LHA
 stimulation. If effective, DBS technology might offer severely obese adults (BMI of ≥50
 kg/m2), who have failed traditional therapy, a non-destructive, adaptable, reversible
 neurosurgical option for altering eating habits leading to sustained weight loss in the
 long-term.
Inclusion Criteria:

 1. Male and female patients age ≥ 22 years and < 65 years old with a BMI of ≥ 50 kg/m2.

 2. 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).

 3. Stable at their present weight (+/- 3 kg) for a 12-month period.

 4. Neuropsychiatric evaluation must not reveal any issues that will be an impediment to
 subject's participation (as listed in Exclusion Criteria 2, 3 and 4).

 5. Karnofsky Performance Score >60.

 6. Platelet count >125,000 per cubic mm.

 7. Prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits.

 Exclusion Criteria:

 1. Any intracranial abnormality or medical condition that would contraindicate DBS
 surgery.

 2. Have a history that includes a prior suicide attempt.

 3. 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.

 4. 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.

 5. 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.

 6. Any history of recurrent or unprovoked seizures.

 7. Any history of hemorrhagic stroke.

 8. Any diagnosis of acute myocardial infarction or cardiac arrest within previous 6
 months.

 9. Any diagnosis of a neurological disorder, such as multiple sclerosis, stroke,
 Parkinson's disease, severe brain atrophy or the presence of subdural hygromas or
 subdural hematomas.

 10. Any history of hypothyroidism.

 11. Any history of demonstrated binge eating.

 12. Concurrent use of weight-loss prescription drug therapy or the use of over-the-counter
 weight loss preparations.

 13. Any prior intracranial surgery or device implantation.

 14. Any other active implanted devices (e.g., spinal cord stimulator, cochlear implant,
 pacemaker, vagus nerve stimulator) and /or drug delivery pumps, whether turned on or
 off. Passive implants (e.g., knee prostheses) would be allowed provided that they
 would not interfere with the DBS.

 15. Any previously implanted Vagus Nerve Stimulation (VNS) patients.

 16. A condition requiring or likely to require the use of Magnetic Resonance Imaging
 (MRI), diathermy or electroconvulsive therapy (ECT).

 17. Likely to require the use of monopolar cautery, radio-frequency (RF) procedures,
 external defibrillation, lithotripsy, radiation therapy or transcranial stimulation.

 18. Currently on any anticoagulant medications that cannot be discontinued during
 perioperative period.

 19. Have any significant medical condition that is likely to interfere with study
 procedures or likely to confound evaluation of study endpoints, (e.g. hepatitis or
 HIV).

 20. Any terminal illness with life expectancy of < 1 year.

 21. Any diagnosis of malignancy (except basal cell of skin) within the past five years.

 22. Any unresolved infection, a coagulopathy or significant cardiac or other medical risk
 factor for surgery.

 23. Current or future risk of being immunocompromised (due to medications, disease
 factors, illness, etc.) that might significantly increase risk of infection.

 24. Participation in any other clinical trial (e.g. drug, device, or biologics)
 concurrently or within the preceding 30 days. Participation in any other study will be
 allowed per investigator/sponsor discretion only.

 25. Plan to receive any procedure that involves sudden jerking motions of the head or neck
 (e.g. certain chiropractic therapies) or massage and manipulation directly over the
 leads in the scalp, neck or chest, at any time during the study.

 26. A female who is breastfeeding or of child-bearing potential with a positive urine
 pregnancy test or not using adequate contraception.

 27. Not able to speak, write and read in English language as determined by the
 investigator.

 28. Overall intellectual abilities below a standard score of 80 based on results from the
 Wechsler Abbreviated Scale of Intelligence (WASI; Wechsler, 1999)

 29. Unable to fit into MRI or CT (Maximum weight limit is 180 kg (396 lb.).

 30. Plasma pre-albumin < 14 mg/dL

 31. Obesity as part of another medical condition, neurological injury or lesions, related
 to medication side effect, or as part of a genetic syndrome (i.e. Prader-Willi
 Syndrome, Leptin deficiency, etc.)

 32. Be eligible for bariatric surgery revision including gastric outlet exclusion,
 gastrogastric fistula or other reasons that would qualify for a revision of their
 gastric bypass

 33. Unable or unwilling to follow up for scheduled clinic visits