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临床试验/NCT01093716
NCT01093716已完成不适用

Comparison of Anti-craving Efficacy of Right and Left Prefrontal High Frequency rTMS in Alcohol Dependence: a Randomized Double-blind Study

Central Institute of Psychiatry, Ranchi, India0 个研究点目标入组 22 人开始时间: 2009年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
主要终点
Craving

研究概览

简要总结

Null hypothesis: There will be no significant difference in the change in craving parameters between right and left prefrontal high frequency rTMS in patients with alcohol dependence.

详细描述

The patients clinically diagnosed as Alcohol dependence syndrome (F 10.24) according to ICD-10 DCR, fulfilling the inclusion and exclusion criteria will be taken up for the study. A detailed physical examination will be done to rule out any major medical or neurological disease. Written informed consent will be taken after explaining the objectives and procedure of the study in detail. To ensure that the patients selected are right handed, Handedness Preference Schedule will be applied. Socio-demographic data will be collected. Baseline SADQ-C and CIWA-Ar will be administered to determine the severity of alcohol dependence and the intensity of withdrawal symptoms respectively. When the CIWA-Ar score becomes ≤ 10, then they will be taken up for rTMS application. For these patients baseline ACQ-NOW will be administered to measure the baseline craving. Patients will be randomly allocated into two groups using randomization table. The first group will receive active rTMS of the right pre-frontal cortex; the second group will be administered active rTMS of the left pre-frontal cortex. Each patient will receive rTMS sessions 5 days a week for 2 weeks. ACQ-NOW score will again be documented in both the groups after the last rTMS session to observe the changes in craving parameters. The rating will be done by one of the authors who will be blind to the nature of rTMS stimulation being administered to the patients.

The motor threshold (MT) for the left abductor pollicis brevis will be determined by a figure of 8 shaped coil, using the Rossini-Rothwell method. MT will be defined as the lowest intensity, which produces 5 motor evoked potential (MEP) responses of at least 50 µV in 10 trials. The prefrontal cortex rTMS stimulation site will be determined by measuring 5 cm anterior and in a parasagittal line from the point of maximum stimulation of left abductor pollicis muscle. Ten active rTMS treatments will be administered at 10 Hz frequency, over right or left prefrontal cortex at 110% of MT for duration of 5 seconds and 20 trains per session, with the coil-angled tangentially to the head.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Diagnosis of Alcohol dependence syndrome according to ICD-10 DCR,
  • Male patients aged between 18-60 years,
  • Patients with CIWA-Ar scores ≤10,
  • Right handed, normotensive patients,
  • Patients giving written informed consent.

排除标准

  • Comorbid psychiatric, major medical or neurological disorders,
  • History of withdrawal seizures, delirium tremens or significant head injury,
  • Subjects with pacemaker or metal in any part of the body excluding the mouth.

结局指标

主要结局

Craving

时间窗: 2 weeks

Alcohol Craving Questionnaire (ACQ-NOW) total score

次要结局

  • Craving(2 weeks)

研究者

发起方
Central Institute of Psychiatry, Ranchi, India
申办方类型
Other

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