Effect of neuromodulation technique (tDCS) in reducing the craving and dependence in alcohol dependence
| ISRCTN | ISRCTN88255964 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88255964 |
- Submission date
- 30/08/2025
- Registration date
- 12/09/2025
- Last edited
- 08/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Alcohol Dependence Syndrome (ADS) represents a major public health challenge worldwide, contributing significantly to the global burden of disease and injury. Craving is now recognized as a diagnostic criterion in the DSM-5, partly due to its association with alterations in brain reward circuitry. Given the potential benefits and the need for improved treatments, this study was designed to investigate the efficacy of transcranial direct current stimulation (tDCS) in a Northern Indian population. The primary aim was to compare the effect of active tDCS versus sham tDCS on reducing alcohol craving and the severity of dependence among inpatients with ADS.
Who can participate?
Patients aged between 18 and 60 years with a diagnosis of ADS who are being admitted to the psychiatry ward
What does the study involve?
Participants were randomly assigned to either Group A (active tDCS) or Group B (sham tDCS) using a computer-generated sequence, with masking achieved through the device’s built-in sham protocol. Both groups underwent ten stimulation sessions over five consecutive days. Group A received bilateral transcranial direct current stimulation (tDCS) at 2 mA for 20 minutes per session, with electrodes placed over the left (cathodal, F3) and right (anodal, F4) dorsolateral prefrontal cortex using saline-soaked sponges. Group B followed the same setup, but received only brief current delivery at the beginning and end of each session to mimic the sensation of active stimulation and maintain blinding.
What are the possible benefits and risks of participating?
Health benefits are seen as a reduction in the craving for substance use.
Notable risks are headache, rash, and tingling sensations, mostly noticed with the use of tDCS.
Where is the study run from?
The Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, India
When is the study starting and how long is it expected to run for?
December 2023 to March 2025
Who is funding the study?
The Swami Rama Himalayan University, India
Who is the main contact?
Dr Shobit Garg, shobit.garg@gmail.com
Contact information
Public, Scientific, Principal Investigator
Dept of Psychiatry, Sri Guru Ram Rai Institute of Medical Sciences, Patel Nagar
Dehradun
248001
India
 ORCID ID |
0000-0001-5913-9021 |
|---|---|
| Phone | +91 8958534261 |
| shobit.garg@gmail.com |
Study information
| Study design | Single-centre interventional single-blinded randomized sham-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Treatment, Efficacy |
| Scientific title | Comparative study of effect of tDCS (Trans cranial direct current stimulation) vs sham tDCS on reducing the craving and severity of dependence among patients of alcohol dependence syndrome |
| Study objectives | To measure the changes in craving as measured using PACS after treatment with tDCS and comparing it with sham tDCS. |
| Ethics approval(s) |
Approved 01/03/2024, Ethics Committee of the Swami Rama Himalayan University (Swami Ram Nagar, Jolly Grant, Dehradun, 248016, India; +91-135-2471111; research@srhu.edu.in), ref: SRHU/HIMS/ETHICS/2024/36 |
| Health condition(s) or problem(s) studied | Reducing the severity and dependence on alcohol in alcohol use disorder. |
| Intervention | Participants were randomly allocated to one of two groups: Group A (active tDCS) or Group B(Sham tDCS) using a computer-generated random number sequence. Masking was done using the built-in sham protocol. The current was only delivered for the first 30 seconds (ramping up) and the last 30 seconds (ramping down) of the 20 minutes. All participants received ten sessions of stimulation over five consecutive days (two sessions per day). 1. Group A (Active tDCS): A weak direct current (2 mA) was delivered for 20 minutes per session. The intervention employed bilateral tDCS, with the cathodal (inhibitory) electrode placed over the left dlPFC (F3 position) and the anodal (excitatory) electrode over the right dlPFC (F4 position). Saline-soaked sponges were used as electrodes. 2. Group B (Sham tDCS): The procedure mirrored the active group, including electrode placement. However, the current was only delivered for the first 30 seconds (ramping up) and the last 30 seconds (ramping down) of the 20 minutes. This method mimics the initial tingling sensations associated with active tDCS, ensuring effective blinding. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Neuromodulation device |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | SOTERIX medical 1*1 Low intensity transcranial direct current stimulation |
| Primary outcome measure | Change in craving as measured using the Penn Alcohol Craving Scale (PACS) at baseline and after 10 sessions of tDCS at day 6 |
| Secondary outcome measures | The role of severity as a mediator for the changes in cravings measured using the Severity of Alcohol Dependence Questionnaire (SADQ) at baseline and after 10 sessions of tDCS at day 6 |
| Overall study start date | 06/12/2023 |
| Completion date | 10/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 48 |
| Key inclusion criteria | 1. Age between 18 and 60 years (both genders) 2. A diagnosis of Alcohol Dependence Syndrome according to ICD-10 DCR criteria 14 3. Admission to the psychiatry ward |
| Key exclusion criteria | 1. Co-morbid substance use disorders (excluding nicotine). 2. Co-morbid psychiatric disorders 3. Uncontrolled or serious medical or surgical illnesses 4. Use of anti-craving or psychotropic medications (except benzodiazepines for withdrawal management) within the past month |
| Date of first enrolment | 10/03/2024 |
| Date of final enrolment | 05/03/2025 |
Locations
Countries of recruitment
- India
Study participating centre
Dehradun
248016
India
Sponsor information
University/education
Swami Ram Nagar, Jolly Grant
Dehradun
248016
India
| Phone | +91-135-2471111 |
|---|---|
| research@srhu.edu.in | |
| Website | https://srhu.edu.in/ |
"ROR" |
https://ror.org/02nw97x94 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- SRHU
- Location
- India
Results and Publications
| Intention to publish date | 05/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Shobit Garg, shobit.garg@gmail.com |
Editorial Notes
01/09/2025: Study's existence confirmed by the Department of Psychiatry, Swami Rama Himalayan University, India.
