Trans-cranial Direct Current Stimulation on Alcohol Craving

Study Overview
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Brief Summary
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The goal of thisclinical trial is to investigate the efficacy of trans cranial direct current stimulation (tDCS) for alcohol craving in individuals with alcohol dependence. The main question it aims to answer is whether 10 sessions of tDCS can reduce craving for alcohol. Participants will be randomized into active group and sham group. Researchers will compare the severity of craving in these groups.

Detailed Description
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Craving is defined as strong desire for substance use, and is one of the core symptoms of alcohol dependence which is highly correlated with relapse. Transcranial direct current stimulation (tDCS) involves applying a small direct current (1-2mA) to the prefrontal cortex; its therapeutic effect for depression and cognition has been demonstrated by several randomized studies. Our preliminary study has shown that tDCS has the potential to reduce craving in alcohol-dependent patients without adverse events. Furthermore, our previous studies have shown that serum brain-derived neurotrophic factor (BDNF) level is elevated after alcohol withdrawal. The current study aims at examining the association between craving and serum BDNF level in alcohol-dependent patients receiving tDCS. The study recruits 40 patients with alcohol dependence. Patients will receive tDCS for 2 weeks during admission, and followed for 2 weeks after tDCS. We'll compare their improvements in craving scores every week, and investigate the correlation between craving and serum BDNF level. This study will bring innovations to the treatment of alcohol dependence based on our previous studies.

Official Title
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Exploring the Effect of Trans-cranial Direct Current Stimulation on Craving and Serum BDNF of Patients With Alcohol Dependence

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Device: transCranial direct current stimulation
* Device: sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be between 20-65 years of age have sufficient cognitive function to understand the study and complete the informed consent process Be diagnosed with alcohol dependence as defined by DSM-IV through a structured interview (Mini-International Neuropsychiatric Interview, M.I.N.I.) Exclusion Criteria: Intellectual disabilities bipolar disorder Psychosis (schizophrenia) Major physical illness (brain hemorrhage, brain tumor, myocardial infarction, epilepsy or history of seizures) intracorporeal electronic or metal implants (e.g., cardiac pacemaker) Pregnant or breastfeeding women Allergy to headgear and electrode materials Trauma or infection to the head Intracranial space occupied lesion (such as brain tumor, AVM, etc.) or patients who have undergone brain surgery, meningitis and encephalitis Patients who are expected to undergo brain and major surgery during the trial period

Ages Eligible for Study
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Minimum Age: 20 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS<br>The intervention consisted of 10 daily 20-min sessions of bilateral prefrontal tDCS (anodal-right/cathodal-left, 2mA; 1 × 1 Mini-CT) | Device: transCranial direct current stimulation<br>* The intervention consisted of 20 daily 20-min sessions of bilateral prefrontal tDCS<br>|
| Sham Comparator: Sham tDCS<br>The sham group consisted of 10 daily 20-min sessions of sham stimulation | Device: sham stimulation<br>* The sham group consisted of 10 daily 20-min sessions of sham stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in alcohol craving | Measured by visual analog scale, from 0-10 | Before intervention (week 0) and after intervention (week 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in brain-derived neurotrophic factor (BDNF) | Serum level of BDNF | Before intervention (week 0) and after intervention (week 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Direct Current Stimulation, craving