| CTRI Number |
CTRI/2025/11/096761 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [REPITITIVE TRANSCRANICAL MAGNETIC STIMULATION] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing brain stimulation therapy (rTMS) plus standard care with sham stimulation plus standard care to reduce alcohol craving in people with alcohol dependence |
|
Scientific Title of Study
|
Evaluating the Impact of Adjuvant Repetitive Transcranial Magnetic Stimulation (rTMS) with Usual Care vs Sham rTMS with Usual Care on Alcohol Craving in Patients with Alcohol Dependence Syndrome: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BUVANESVARAN S |
| Designation |
Resident, MD Psychiatry |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Psychiatry, Armed Forces Medical College, Wanowarie
Pune MAHARASHTRA 411040 India |
| Phone |
9047444789 |
| Fax |
|
| Email |
buvan10000@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
JYOTI PRAKASH |
| Designation |
Professor and HoD |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE |
| Address |
Department of Psychiatry, AFMC Pune
Pune MAHARASHTRA 411040 India |
| Phone |
9830544652 |
| Fax |
|
| Email |
drjyotiprakashpsy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
BUVANESVARAN S |
| Designation |
Resident, MD Psychiatry |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Psychiatry, Armed Forces Medical College, Wanowarie
Pune MAHARASHTRA 411040 India |
| Phone |
9047444789 |
| Fax |
|
| Email |
buvan10000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
N/A |
| Type of Sponsor |
Other [N/A] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Buvanesvaran S |
Armed Forces Medical College |
Wanowrie, Pune, Maharashtra- 411040 Pune MAHARASHTRA |
9047444789
buvan10000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AFMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H||Substance Abuse Treatment, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
REPITITIVE TRANSCRANICAL MAGNETIC STIMULATION |
High-frequency (10 Hz) rTMS over left DLPFC, 2,000 pulses/session, for 10 consecutive days along with standard care |
| Comparator Agent |
SHAM REPITITIVE TRANSCRANIAL MAGNETIC STIMUALTION |
A placebo-like procedure mimicking active rTMS in sound and sensation but without delivering active stimulation along with standard care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
Adults aged 18-60 years diagnosed with Alcohol Dependence Syndrome
|
|
| ExclusionCriteria |
| Details |
History of epilepsy or seizure disorders
Presence of metal implants or devices
Severe psychiatric conditions
Severe debilitating medical / surgical conditions
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary endpoint is the change in alcohol craving scores from baseline to post-intervention (Day 11), and at 1-month and 3-month follow-ups, measured by Alcohol Craving Questionnaire NOW scale
|
baseline to post-intervention (Day 11), and at 1-month and 3-month follow-ups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Evaluating the Impact of Adjuvant Repetitive Transcranial Magnetic Stimulation with Usual Care vs Sham rTMS with Usual Care on Alcohol Craving in Patients with Alcohol Dependence Syndrome A Randomized Controlled Trial is a clinical study designed to examine the efficacy of rTMS as an adjunctive treatment in reducing alcohol craving among adults aged 18 to 60 years diagnosed with Alcohol Dependence Syndrome. Conducted at a tertiary care hospital in Western Maharashtra, the trial randomizes 150 participants into two groups active rTMS and sham stimulation with each receiving ten daily sessions 10 Hz, 1000 pulses per session over the left dorsolateral prefrontal cortex. Participants are assessed using the Alcohol Craving Questionnaire NOW at baseline, on day 11, and at 1 and 3 month followups. The intervention is grounded in neurobiological evidence that dysregulated prefrontal-limbic circuits drive craving and relapse. Studies by Harel et al and a 2025 meta-analysis by Treiber et al demonstrate that more than 10 sessions of high-frequency rTMS significantly reduce craving, with effects persisting up to three months. This project aims to generate robust Indian data on the effectiveness and sustainability of rTMS in relapse prevention, potentially integrating this non-pharmacological neuromodulation technique into standard care for alcohol dependence. |