The Effect of Non Invasive Brain Stimulation [Transcranial Direct Current Stimulation (tDCS)] on Craving In Alcohol Dependent Patients
- Conditions
- Health Condition 1: F102- Alcohol dependence
- Registration Number
- CTRI/2022/03/040823
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 149
1) Alcohol Use Disorder as per DSM 5 criteria and Severe Dependence [Severity of Dependence
Questionnaire (SADQ) score greater than 30]
2) Craving on Current Assessment [Obsessive Compulsive Drinking Scale (OCDS) score greater than 1]
3) Age between 18 and 45 years
4) Right handed (Edinburgh Handedness Inventory)
5) Willing to give written informed consent
1)Other current substance use disorder as per DSM 5 (except nicotine)
2)Current and past psychiatric comorbidity in the last 6 months as per DSM 5, assessed during
workup
3)History of complicated alcohol withdrawal in the last 6 months
4)Current or past history of Wernicke s Encephalopathy, Korsakoff Syndrome
5)Patients who have received mECT or any other form of brain neuromodulation in past 6 months.
6)Clinical or past history suggestive of Intellectual Disability
7) History suggestive of substantial brain damage, brain aneurysm, any other neurological disorder
or history of neurosurgery.
8) Decompensated systemic illness (eg. Decompensated hepatic encephalopathy or decompensated cirrhosis) interfering with neurocognitive performance
9)Physical Disability limiting use of computer for online tasks
10) On Benzodiazepines, Anticholinergics, Opioids
11) Patients with medical implants such as defibrillators or pacemakers or brain aneurysmal clips.
12) Patients with relative contraindications to tDCS like migraine, skin lesions involving scalp, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Craving for Alcohol, measured by the decrease in Obsessive <br/ ><br>Compulsive Drinking Scale (OCDS) at 1 month after completion of 10 session tDCSTimepoint: Craving for Alcohol, measured by the decrease by OCDS at 1 month after completion of 10 session tDCS
- Secondary Outcome Measures
Name Time Method 2) In Executive function as measured by Stop Signal Reaction TimeTimepoint: 1 month and 3 months after 10 sessions of tDCS;3) In alteration of pre-frontal cortex Hb (Haemoglobin) saturation parameters (HbO2, HHb and tHb) by fNIRS (Functional Near Infrared Spectroscopy).Timepoint: 1 month and 3 months after 10 sessions of tDCS;Active vs sham comparison in Alcohol dependence patients with SADQ score more than 30 and receiving <br/ ><br>10 sessions of tDCS <br/ ><br>1) In alcohol use related parameters by Timeline Follow Back methodTimepoint: 1 month and 3 months after 10 sessions of tDCS