NCT04453020撤回不适用
Pilot Study to Evaluate Deep Brain Stimulation (DBS) of the Lateral Hypothalamic Area (LHA) on Energy Balance and Feeding Behavior in Patients With Chronic Refractory Obesity
donald whiting2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年2月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Safety - Complication Rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients age ≥ 22 years and < 65 years old with a BMI of ≥ 40 kg/m
- •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.
- •Neuropsychiatric evaluation must not reveal any issues that will be an impediment to subject's participation (as listed in
排除标准
- •2, 3 and 4).
- •Karnofsky Performance Score >
- •Platelet count >125,000 per cubic mm.
- •Prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits.
- •Exclusion Criteria:
- •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 ≥
- •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.
- •Any history of recurrent or unprovoked seizures.
- •Any history of hemorrhagic stroke.
- •Any diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
- •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.
- •Any history of hypothyroidism.
- •Any history of demonstrated binge eating.
- •Concurrent use of weight-loss prescription drug therapy or the use of over-the-counter weight loss preparations.
- •Any prior intracranial surgery or device implantation.
- •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.
- •Any previously implanted Vagus Nerve Stimulation (VNS) patients.
- •A condition requiring or likely to require the use of Magnetic Resonance Imaging (MRI), diathermy or electroconvulsive therapy (ECT).
- •Likely to require the use of monopolar cautery, radio-frequency (RF) procedures, external defibrillation, lithotripsy, radiation therapy or transcranial stimulation.
- •Currently on any anticoagulant medications that cannot be discontinued during perioperative period.
- •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).
- •Any terminal illness with life expectancy of < 1 year.
- •Any diagnosis of malignancy (except basal cell of skin) within the past five years.
- •Any unresolved infection, a coagulopathy or significant cardiac or other medical risk factor for surgery.
- •Current or future risk of being immunocompromised (due to medications, disease factors, illness, etc.) that might significantly increase risk of infection.
- •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.
- •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.
- •A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
- •Not able to speak, write and read in English language as determined by the investigator.
- •Overall intellectual abilities below a standard score of 80 based on results from the Wechsler Abbreviated Scale of Intelligence (WASI; Wechsler, 1999)
- •Unable to fit into MRI or CT (Maximum weight limit is 180 kg (396 lb.).
- •Plasma pre-albumin < 14 mg/dL
- •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.)
- •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
- •Unable or unwilling to follow up for scheduled clinic visits
结局指标
主要结局
Safety - Complication Rates
时间窗: 12 months
Adverse Events
次要结局
- Energy intake(2 months and 4-5 months post-surgery)
- Impact of weight on quality of life: IWQOL-Lite(Baseline, 2 months and 4-5 months post-surgery)
- Resting metabolic rate (RMR)(Baseline, 2 months, 4-5 months and 20 months post-surgery)
- Eating inventory(Baseline, 2 months and 4-5 months post-surgery)
- Binge Eating Scale (BES)(Baseline, 2 months and 4-5 months post-surgery)
- Yale Food Addiction Scale(Baseline, 2 months and 4-5 months post-surgery)
- Power of Food Scale(Baseline, 2 months and 4-5 months post-surgery)
- Body shape perception(Baseline, 2 months and 4-5 months post-surgery)
- Food craving inventory(Baseline, 2 months and 4-5 months post-surgery)
- Food preferences(Baseline, 2 months and 4-5 months post-surgery)
- Delayed reward discounting(Baseline, 2 months and 4-5 months post-surgery)
- Appetitive sensations(Baseline, 2 months and 4-5 months post-surgery)
- Quality of life measure: SF-36(Baseline, 2 months and 4-5 months post-surgery)
- Depression score(Baseline, 2 months and 4-5 months post-surgery)
- Changes in metabolic hormone profiles(2 months and 4-5 months post-surgery)
- Body mass index(Baseline, 2 weeks, 2 months, 4-5 months, 6 months, 9 months, 12 months, 15 months, 18 months, 20 months and 24 months post-surgery)
- Change in DXA body composition(2 months and 4-5 months post-surgery)
研究者
donald whiting
Principal Investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
研究点 (2)
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