Role of adjuvant Intermittent Theta Burst stimulation over right dorsolateral prefrontal cortex in patients with alcohol use disorders , a randomized double blind sham controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- effect of intermittent theta burst stimulation in patients with alcohol use disorder on craving
研究概览
简要总结
TOPIC OF RESEARCH-“ROLE OF ADJUVANT INTERMITTENT THETA BURST STIMULATION OVER RIGHT DORSOLATERAL PREFRONTAL CORTEX IN PATIENTS WITH ALCOHOL USE DISORDERS: A RANDOMIZED DOUBLE BLIND SHAM CONTROLLED TRIALâ€
**OBJECTIVE-**To assess the role of adjunctive intermittent theta burst stimulation over the right dorsolateral prefrontal cortex in patients with alcohol use disorders compared with sham stimulation over the right dorsolateral prefrontal cortex .
**METHODOLGY:**A randomized, double blind sham controlled trial will be carried out in 60 patients diagnosed with alcohol use disorders and fulfilling the inclusion and exclusion criteria, and upon receiving the informed consent will be admitted in our inpatient department and undergo detoxification procedure after which, these patients will be randomly allocated by computer generated randomization tables into 2 groups . Patients will be unaware of the type of RTMS they will receive .During the course of intervention with transcranial magnetic stimulation, patients will receive evidence based psychotherapy which will be provided by a team of clinical psychologists, who will be unaware regarding any details of Rtms , and they will be provided symptomatic treatment with medicines like paracetamol and benzodiazepines on sos basis .30 patients will be receiving adjunctive active treatment with intermittent theta burst stimulation and 30 patients will be receiving adjunctive sham stimulation. Handedness of the patient will be ascertained. Motor threshold will be measured as per protocol and subsequent intermittent theta burst stimulation or sham stimulation will be delivered over the right dorsolateral prefrontal cortex region twice daily on weekdays for 10 days, a total of 20 sessions. The baseline assessment of alcohol use and pattern , craving will be done prior to active or sham stimulation and after 7 days, 14 days , 1 month and 3 months of intervention by another psychiatrist who will not be involved in administration of RTMS. Blood test for Mean corpuscular volume and Gamma Glutamyl Transferase, Liver function tests, Uric acid, will be done on admission and at 1 month and 3 months after intervention .
**EXPECTED OUTCOME-**Adjunctive intermittent theta burst stimulation over the right dorsolateral prefrontal cortex in the patients with alcohol use disorders after will reduce craving ,the amount of
daily intake of alcohol, and days until relapse , as compared to sham stimulation .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •AGE OF PATIENT 18 TO 65 YRS IF AGE OF EITHER GENDER
- •Subjects who have given consent for participation in the study
- •Subjects meeting DSM V criteria for alcohol use disorder, not meeting criteria for dependence to other substances except for nicotine and caffeine.
- •Subjects whose last intake of alcohol will be within the past 2 weeks.
- •Subjects who are not suffering from psychosis , not in acute withdrawal state with CIWA AR score less than 10 and not suffering from delirium.
排除标准
- •Cognitive impairment
- •Current DSM V diagnosis of major depression , schizophrenia or any other psychotic disorder, or any other comorbid psychiatric illness .
- •Standard rTMS contraindications like history of epilepsy, metal implants near the head or in any part of the body , history of neurosurgical operations , pacemaker implant
- •Concurrent use of medications or drugs that are known to reduce the seizure threshold.
- •Subjects with intellectual disabilities.
结局指标
主要结局
effect of intermittent theta burst stimulation in patients with alcohol use disorder on craving
时间窗: DAY 7, 2 WEEKS ,4 WEEKS , 12 WEEKS
次要结局
- time to relapse(within 3months of intervention)
研究者
Dr Suvrangshu Chattaraj
Institute of Psychiatry A centre of excellence, IPGMER and SSKM hospital