Deep Brain Stimulation on the Subgenual Cingulate and Accumbens Nucleus for Patients With Chronic, Severe and Resistant Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Body mass index (BMI)
研究概览
简要总结
Deep brain stimulacion (DBS) clinical study in the subcallosal cingulate (CSG) and accumbens nucleus (NAc) for 8 patients with treatment-refractory, cronic and severe anorexia nervosa (AN) patients. The main objective is to show efficacy and safety. Studies show that SSG and NAc are strategical targets in the pathophysiology and the hypothetical surgical treatment in AN patients. The patients distribution (4 patients in each target) it will made by the AN type and the comorbidity associated, the reasons are: 1- It is well known the comorbidity treatment imoportance in the AN evolution, 2- The two differentes types of AN have differents clinical behaviour and prognosis, 3- Studies show efficacy in TOC and DM patients with NAc DBS and in DM patients with CSG DBS. The main variable is BMI. After a 6 months stabilization evaluation phase will be followed (only in patients that have increase 10% BMI) by a double-bind, crossover phase, where patients will receive 3 months with stimulation turned on and 3 month with turned off. All patients will have a 12 months follow up. The study secondary objectives are to know the relation btween the stimulacion answer (increase 10% BMI) and the differents variables, specially AN type, associated cormobidity, selected target and preoperative MRI tractography study.
详细描述
HYPOTHESIS OF THE CLINICAL TRIAL
Based on the results of functional, preclinical, clinical and neurocircuit imaging studies in patients with Anorexia Nervosa (AN) and in the results of deep brain stimulation (DBS) in 81 other mental illnesses and in AN, our main hypotheses are:
- The subgeneric cingulate (CSG) and nucleus accumbens (NAc) are strategic targets in AN patients, so deep brain stimulation in these two targets may be effective in the treatment of AN patients.
- The stimulation of the CSG and the NAc has been safe in other mental illnesses so it can also be in patients with AN.
VARIABLES
The variables to be studied are: age, years of illness, number of admissions, type of AN, drugs tested, drugs at the present time, non-pharmacological treatments received, weight and current BMI, weight and mean BMI of the last year, associated comorbidity, Hamilton Scale for Depression (HAMD-17), Hamilton Scale for Anxiety (HAMA), Obsessive Compulsive Yale-Brown Scale (YBOCS), Cornell Scale for Eating Disorder (YBC-EDS), Quality of Life Scale SF-36, stimulation variables (voltage, frequency, pulse amplitude, active contacts), stimulated target (CSG, NAc), complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(All criteria for inclusion must be met)
- •Age between 18-60 years
- •Diagnosis of AN, both restrictive type and compulsion / purge type defined by the DSM-V-TR
- •Chronicity: minimum of 10 years of illness.
- •Resistance to treatment, shown by one or both of the following situations:
- •A. That of the multiple treatments performed, at least 1 is an intensive treatment (hospitalization or day hospital), with one or more of the following results:
- •I have not been able to finish the treatment.
- •That it has finished but with little or no answer.
- •That in spite of having finished it, and of having answered, Has found a subsequent relapse in the first six months. B. Clinical situation of medical instability, accompanied by refusal to participate in any treatment program and including at least 1 episode of admission for involuntary feeding.
- •Extremely serious (BMI less than 15), or severe (BMI between 15-15,99)
- •Ability to sign informed consent
- •Ability to undergo all tests and follow-ups of the study
排除标准
- •BMI less than 13 at the time of recruitment for the study.
- •Psychosis in the present moment or in the past.
- •Current neurological disease.
- •Substance or alcohol abuse and dependence in the last year.
- •Contraindications to perform a brain MRI
- •Presence of cardiac arrhythmias or other cardiac, respiratory, renal or endocrine affections, as a result of AN or not, that carries risk for the surgical procedure.
结局指标
主要结局
Body mass index (BMI)
时间窗: From baseline till 12 months
BMI will be measured monthly from baseline till 12 months. Data will be compared with BMI in the beginning of the open label period
次要结局
- Adverse events during the study(From baseline till 12 months)
- Psychiatric comorbidity(From baseline till 12 months)
研究者
Víctor Pérez
PhD MD
Parc de Salut Mar