Health Condition 1: F102- Alcohol dependence
Conditions
Interventions
Intervention1: Active Auricular Percutaneous Electrical Neural Field Stimulation (PENFS): Auricular Percutaneous Electrical Neural Field Stimulation (PENFS) device will stimulate the Left ear cymba co
Sponsors
National Institute of Mental Health and Neurosciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Alcohol dependence syndrome (ADS) as per ICD-10 concurred by two psychiatrists working in the department of psychiatry NIMHANS. 2. At least, moderately severe ADS as ascertained by a score above 16 in Severity of Alcohol dependence questionnaire (SADQ). 3. Right-handedness as assessed with Edinburgh Handedness Inventory. 4. Informed consent and willingness to come for regular follow-ups (once every two weeks) for three months after recruitment in the study.
Exclusion criteria
Exclusion criteria: 1. Any major psychiatric disorder diagnosis except alcohol dependence syndrome/ Tobacco dependence syndrome (to apply MINI screen). 2. Contra-indications precluding device use- 2.1 patient with cardiac implants or similar biomedical implants, 2.2 during pregnancy unless medically advised, 2.3 patient with hemophilia 2.4 skin pathology 2.5 patient with diminished mental capability or physical competence about the handling of the device 3. Left/ mixed handedness 4. Contraindications to MRI 5. Patient with seizure, delirium and head injury
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in craving scores measured with Penns Alcohol Craving Scale between baseline and equispaced 6 follow-ups (every 15 days) for 3 months.Timepoint: Time-Points are as follows Time 0 is On the day of recruitment. Time 1 is Day 15 of recruitment. Time 2 is Day 30 of recruitment. Time 3 is Day 45 of recruitment. Time 4 is Day 60 of recruitment. Time 5 is Day 75 of recruitment. Time 6 (Final)is Day 90 of recruitment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Cue-induced craving as measured by the VICE protocol 6-minute Visual Image Induced Craving for Ethanol (VICE) paradigm fMRI and resting state fMRI neurohemodynamic changes in the dorsolateral prefrontal cortex, anterior cingulate cortex (ACC) and insular cortex (IC) after 14 days PENFS. Timepoint: Time-Points are as follows Time 0 is on the day of recruitment. Time 1 is on Day 14 of recruitment. | — |
Countries
India
Contacts
Public ContactDiptadhi Mukherjee
National Institute of Mental Health and Neuro Sciences(NIMHANS)
Outcome results
None listed