Hungry for Reward : A Pilot Investigation of the Ethics, Practice and Neural Basis of Deep Brain Stimulation to the Nucleus Accumbens in Severe Intractible Anorexia Nervosa.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Eating Disorder Pathology
研究概览
简要总结
Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of effective treatments. AN becomes intractable in around 20%, resulting in huge individual and healthcare costs. Exploration of underlying processes and novel treatment strategies is thus crucial. This is a pilot study of a novel translational approach to the investigation and treatment of severe AN. The aims are (1) to explore the safety, acceptability and feasibility of Deep Brain Stimulation (DBS) for AN (2) to map neural mechanisms underpinning aberrant reward and optimise DBS targets. The study will involve 10 consenting adults with full mental capacity, and the nain protocol will last 15 months. . There is then optional annual follow ups for up to 5 years .It incorporates an ethical substudy including assessment of capacity and informed consent. It combines complementary forms of cutting edge neuroimaging including fMRI and MEG (magnetoencephalography). These will be complimentary in helping identify the best strategy for treating severe AN using DBS. Individuals with severe intractable AN will be eligible to take part. The study will be conducted in Oxford, United Kingdom at the John Radcliffe and Warneford Hospitals. The individuals will have preoperative ethical, neuroimaging and psychological assessments, A DBS operation in month 2, DBS switch on in month 3 month postoperatively . DBS will be targeted to the Nucleus accumbens, followed by a 12 month post switch on follow-up period with monthly joint neurosurgical psychiatric and psychological assessments and postoperative MEG scans . The study will further our understanding of food reward processes in general and AN in particular indeed promises to provide important information which may revolutionize future treatments. The proposal builds upon a body of research investigating the role of aberrant reward processes in AN and exploits our complementary research experience in AN using experimental behavioural strategies, fMRI , MEG and DBS to establish a powerful translational research strategy.
详细描述
Our hypothesis, based on prior research, is that DBS to the nucleus accumbens will have beneficial neural and symptomatic effects in severe Anorexia Nervosa.
As a test of this hypothesis, and to evaluate acceptability and ethical issues we aim to initially study up to 10 patients.
This study may provide important clinical and scientific information to contribute to larger studies.
DESIGN SUMMARY The design will consist of a case series of 10 patients with repeated measures. The individuals will be aged 20-65 with at least 7 years history of severe treatment resistant AN, who are fully consenting and motivated to recover.
The patients will be selected on the basis of specific suitability criteria. A small case series study design is needed as this is a novel and invasive strategy, and further information about acceptability, feasibility and neural processes involved is required to inform more extensive studies. This can optimally be obtained by initial detailed study of a small number of patients. As some heterogeneity of response is likely, as advised by our external reviewer Professor Walter Kaye, we are aiming to study 10 patients ..
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis: Anorexia Nervosa according to the DSMIV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition)criteria based on a psychiatric interview
- •Illness duration of severe AN > 7 years
- •Disabling severity with substantial functional impairment
- •Female Gender and right handed
- •Treatment refractoriness, defined as lack of response to two or more typical modes of treatment, such as inpatient weight restoration, psychotherapy and psychopharmacology
- •Severely underweight: BMI >13 <16
- •Age: 20-65 years old
- •Written informed consent
- •Able to fully understand the consequences of the procedure
- •English speaking and able to answer the study questions fluently
- •Having the mental capacity to make provide informed consent to research participation
排除标准
- •Unstable physical condition (severe electrolyte disturbances, cardiac failure, other physical conditions due to underweight in which surgery/anaesthesia is contraindicated)
- •Treatable underlying cause of anorexia/underweight
- •Parkinson's disease, dementia, epilepsy
- •History of schizophrenia/ psychosis, bipolar disorder
- •Alcohol or substance abuse (including benzodiazepines) during the last 6 months
- •Current severe major depressive or Tic disorder
- •Antisocial or Severe Borderline Personality Disorder
- •Standard MRI scan exclusion criteria (pregnancy, pacemaker and metals contraindicated for MRI except for the DBS implantation and stimulator itself)
- •Current Involuntary patient
结局指标
主要结局
Eating Disorder Pathology
时间窗: 15 months
BMI
Adverse events associated with surgery or stimulation
时间窗: 13 months post operatively
Eating Disorder pathology
时间窗: 15 months
Global EDE Score, Yale brown ED scale
次要结局
- MEG 'Resting State Network'(15 months)
- Comorbid psychiatric symptoms(15 months)
- Hamilton score(15 months)
- Food Reward processing(15 months)