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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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