Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Alcohol Dependence

Study Overview
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Brief Summary
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Alcohol dependence is one of most common substance dependence, which brings great burden on health worldwide. Alcohol dependence may lead to many serious diseases or consequences including cancer, cardiovascular diseases and accidents. Once alcohol dependence is developed, it will be difficult to recover and easy to relapse. Although many efforts had been made in the treatment of alcohol dependence, the annual recurrence of alcohol dependence with traditional therapies was over 45%. Repetitive transcranial magnetic stimulation (rTMS) on the dorsolateral prefrontal cortex (DLPFC) or cognitive behavioral therapy (CBT) each alone was reported to have some effect on preventing from relapse of alcohol dependence. In order to test whether combined therapy of high frequency rTMS (hf-rTMS) with CBT is better for preventing from relapse of alcohol dependence, we recruit patients with alcohol dependence to participate this study. The study is a factorial designed and the patients will be assigned into one of the following six groups randomly: (1) regular treatment (symptomatic treatment) with blank TMS; (2) regular treatment (RT) with blank TMS and CBT; (3) RT with right DLPFC hf-rTMS; (4) RT with right DLPFC hf-rTMS and CBT; (5) RT with left DLPFC hf-rTMS; (6) RT with left DLPFC hf-rTMS and CBT. TMS was given 5 days per week for total 2 weeks using uniform scheme (5 seconds of 10Hz stimulation per train, 30 trains per day with inter-train interval of 20 seconds). CBT will be given once per week for total 8 weeks. The patients will be followed up for 6 months. Recurrence of alcohol dependence, duration of abstention, alcohol intake, craving for alcohol and other cognitive psychological assessments will be recorded and compared among the 6 treatment groups and the efficacy of combined therapy of rTMS with CBT will be evaluated in our study.

Official Title
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Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Alcohol Dependence

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis as alcohol dependence according to DSM-IV criteria No definite history of neurological diseases and psychological problems Volunteer to participate the study, cooperate to be followed up Exclusion Criteria: Acute withdrawal state and CIWA score > 9 With other neurological diseases and psychological problems With ever brain trauma and damage With other psychological medications or other substance dependence With other contraindications to have transcranial magnetic stimulation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Regular treatment (symptomatic treatment) with blank TMS<br>Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation | Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy<br>* Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy<br>|
| Active Comparator: Regular treatment (RT) with blank TMS and CBT<br>Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation and cognitive behavioral therapy | Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy<br>* Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy<br>|
| Active Comparator: RT with right DLPFC hf-rTMS<br>Regular treatment with right dorsolateral prefrontal cortex (DLPFC) high frequency repetitive transcranial magnetic stimulation (hf-rTMS) | Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy<br>* Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy<br>|
| Active Comparator: RT with right DLPFC hf-rTMS and CBT<br>Regular treatment with right DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT) | Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy<br>* Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy<br>|
| Active Comparator: RT with left DLPFC hf-rTMS<br>Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) | Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy<br>* Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy<br>|
| Active Comparator: RT with left DLPFC hf-rTMS and CBT<br>Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT) | Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy<br>* Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of relapse of alcohol dependence after discharge from hospital | Recurrence of alcohol dependence | 1 month | 
| The rate of relapse of alcohol dependence after discharge from hospital |  | 2 month | 
| The rate of relapse of alcohol dependence after discharge from hospital |  | 3 month | 
| The rate of relapse of alcohol dependence after discharge from hospital |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of abstinence | The total time or period without any intake of alcohol during follow ups | 6 months | 
| Alcohol intake | Diaries of alcohol intake in different time of the follow ups | 2 weeks, 1 month, 2 months, 3 months and 6 months | 
| Craving for alcohol | Craving assessment for alcohol by Obsessive Compulsive Drinking Scale (OCDS) ranging from 0 to 40. Higher score of OCDS indicates more desire for alcohol. | 2 weeks, 1 month, 2 months, 3 months and 6 months | 
| Craving for alcohol | Craving assessment by Visual Analogue Scale (VAS) for alcohol desire ranging from 0 to 10. Higher score indicates more desire for alcohol. | 2 weeks, 1 month, 2 months, 3 months and 6 months | 
| Cognitive assessment | Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function. | 2 weeks, 1 month, 2 months, 3 months and 6 months | 
| Psychological assessment - Anxiety | Psychological assessment by Generalized Anxiety Disorder-7 (GAD-7) ranging from 0 to 21. Higher score indicates more severer anxiety. | 2 weeks, 1 month, 2 months, 3 months and 6 months | 
| Psychological assessment - Depression | Psychological assessment by Patient Health Questionnaire-9 (PHQ-9) ranging from 0 to 27. Higher score indicates more severer depression. | 2 weeks, 1 month, 2 months, 3 months and 6 months | 
| Psychological assessment - Sleep | Psychological assessment by Pittsburgh Sleep Quality Index (PSQI) ranging from 0 to 21. Higher score indicates worse sleep. | 2 weeks, 1 month, 2 months, 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Dependence, transcranial magnetic stimulation, cognitive behavioral therapy