Brain stimulation to reduce craving in alcohol dependent individuals
Phase 4
- Conditions
- Health Condition 1: F102- Alcohol dependence
- Registration Number
- CTRI/2020/09/027582
- Lead Sponsor
- Anagha S Deshmukh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
a) Patients diagnosed with Alcohol Dependence Syndrome according to ICD-10 Diagnostic Criteria for Research (WHO 1993)
b) Male patients aged between 18 â?? 60 years
c) Right-handed
d) Patients not in active withdrawal as defined by CIWA-Ar score less than 10
e) Patients with at least 5 years of formal education
f) Ability to read, write and speak Kannada or Hindi or English
Exclusion Criteria
a) Patients fulfilling ICD-10 Diagnostic Criteria for Research (WHO 1993) for other substance dependence syndrome, except nicotine
b) History of comorbid other major psychiatric disorder(s) or major medical disorder(s)
c) History of epilepsy, significant head injury or any neurosurgical procedure
d) Any metallic brain implant or cardiac pacemaker
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method These would include the duration of time to the first drink, cue-induced craving measured on OCDS and the scores on risk taking and impulsivity as measured on the IGT and BART tasks respectively.Timepoint: The data will be collected at 5 time points - baseline, after 10 tDCS sessions, at weeks follow up, at 1 month follow up and at 3 months follow up
- Secondary Outcome Measures
Name Time Method These would include the severity of lapse as measured by the quantity frequency index, scores on other neuropsychological domains and blood biomarker levels of BDNF, leptin and adiponectinTimepoint: The data will be collected at 5 time points - baseline, after 10 tDCS sessions, at weeks follow up, at 1 month follow up and at 3 months follow up