A Study of New Treatment for Excessive Alcohol Users by Electric Stimulation of Nerves Around Ear
Alcohol Use Disorder
About this trial
This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Alcohol dependence, Peripheral electrical nerve field stimulation (PENFS), Auricular nerve stimulation, Vagus nerve stimulation, relapse prevention
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Alcohol use disorder (AUD) as per DSM(Diagnostic and Statistical Manual of Mental Disorders)-5 by two psychiatrists working in the department of psychiatry NIMHANS.
- Male gender.
- Age not less than 18 years and not more than 50 years.
- At least, moderately severe AUD as ascertained by a score above 16 in Severity of Alcohol dependence questionnaire (SADQ).
- Right-handedness as assessed with Edinburgh Handedness Inventory.
- Informed consent and willingness to come for regular follow-ups (once every two weeks) for three months after recruitment in the study.
Exclusion Criteria:
- Any diagnosis except alcohol dependence syndrome/ Tobacco dependence syndrome (to apply MINI(Mini International Neuropsychiatric Interview) screen).
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 haemophilia 2.4 skin pathology 2.5 patient with diminished mental capability or physical competence about the handling of the device
- Left/ mixed handedness
- Contraindications to MRI
Sites / Locations
- National Institute of Mental Health and Neuro sciences(NIMHANS)
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Active Arm
Sham Arm
Active arm: Auricular Percutaneous Electrical Neural Field Stimulation (PENFS) device will stimulate the outer auditory canal. It will deliver with a pulse width of 500 ms. The stimulation frequency pattern is 1.12Hz(hertz), 2.24Hz,4.56Hz, 9.12Hz, 100Hz then 9.12Hz, 4.56Hz,2.28Hz,1.12Hz. This cycle will keep on continuing. An input voltage will be 4.2V(volt).
Sham arm: Auricular Percutaneous Electrical Neural Field Stimulation (PENFS) device will stimulate centre of the left ear lobe to a pulse width of 500 ms at same pattern of stimulation frequency mentioned in active PENFS with an input voltage of 4.2V