A study of new treatment for excessive alcohol users by electric stimulation of nerves around ear

Not Applicable

• Conditions: Health Condition 1: F102- Alcohol dependence

• Registration Number: CTRI/2019/09/021367
• Lead Sponsor: ational Institute of Mental Health and Neurosciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br/ ><br>Time 0 is On the day of recruitment. <br/ ><br>Time 1 is Day 15 of recruitment. <br/ ><br>Time 2 is Day 30 of recruitment. <br/ ><br>Time 3 is Day 45 of recruitment. <br/ ><br>Time 4 is Day 60 of recruitment. <br/ ><br>Time 5 is Day 75 of recruitment. <br/ ><br>Time 6 (Final)is Day 90 of recruitment.

Secondary Outcome Measures

Name	Time	Method
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. <br/ ><br>Timepoint: Time-Points are as follows <br/ ><br>Time 0 is on the day of recruitment. <br/ ><br>Time 1 is on Day 14 of recruitment. <br/ ><br> <br/ ><br>