| CTRI Number |
CTRI/2025/10/096438 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of non-invasive high frequency magnetic stimulation of brain (HF-rTMS) on alcohol craving in patients with alcohol dependence |
|
Scientific Title of Study
|
The effect of high-frequency rTMS on alcohol craving – Results from a double-blinded randomized sham-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 |
Dr Vijeyta N |
| Designation |
Post-graduate |
| Affiliation |
Government Stanley medical college and hospital |
| Address |
Department of Psychiatry, Government Stanley medical college and hospital, Old jail road, George town, Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9629020316 |
| Fax |
|
| Email |
drvijeytanaresh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijeyta N |
| Designation |
Post-graduate |
| Affiliation |
Government Stanley medical college and hospital |
| Address |
Department of Psychiatry, Government Stanley medical college and hospital, Old jail road, George town, Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9629020316 |
| Fax |
|
| Email |
drvijeytanaresh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijeyta N |
| Designation |
Post-graduate |
| Affiliation |
Government Stanley medical college and hospital |
| Address |
Department of Psychiatry, Government Stanley medical college and hospital, Old jail road, George town, Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9629020316 |
| Fax |
|
| Email |
drvijeytanaresh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry, Government Stanley medical college and hospital, Old jail road, George town, Chennai,Tamilnadu-600001, India |
|
|
Primary Sponsor
|
| Name |
Department of Psychiatry |
| Address |
Government Stanley medical college and hospital, Old jail road, George town, Chennai,Tamilnadu-600001, India |
| Type of Sponsor |
Government medical college |
|
|
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 Sabitha V |
Government Stanley medical college and hospital |
OP No-37, D-block, Department of Psychiatry, Government Stanley medical college and hospital, Old jail road, George town, Chennai,Tamilnadu-600001, India
Chennai
TAMIL NADU |
9443091559
sabithapsy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Stanley medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High frequency rTMS |
High-frequency rTMS will be applied over the right prefrontal cortex.
Stimulation Frequency: 10 Hz.
Stimulation Intensity: 110% of individual resting motor threshold.
Train Duration: 5 seconds.
Inter-Train Interval: 10 seconds.
Number of Trains per Session: 60 ( approx ~ 15 mins).
Pulses per Session: 3,000.
Number of Sessions: once daily for 10 days.
Total Pulses Across Treatment: 30,000. |
| Comparator Agent |
Sham rTMS |
Sham stimulation will be delivered using the tilted coil method, where the magnetic coil is positioned at a 90° angle from the scalp to mimic the sound and scalp sensation of active rTMS while minimizing cortical stimulation. This approach maintains perceptual similarity and protects the integrity of blinding. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults more than or equal to 18 years with ICD 11 diagnosis of Alcohol Dependence. Patients not in active withdrawal that is, CIWA-Ar less than or equal to 10 at enrollment. Right-handed and willing to stay for 10-day intervention. Provided written informed consent |
|
| ExclusionCriteria |
| Details |
History of seizures, epilepsy, or neurological conditions. Implanted metal devices or medications lowering seizure threshold. Severe psychiatric comorbidity like schizophrenia, BPAD etc,. Pregnancy, lactation, or concurrent substance dependence |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in alcohol craving |
alcohol craving, measured using the Alcohol Craving Questionnaire (ACQ)-SF-R, across five timepoints: baseline, post-treatment, one-month, three-month and six-month follow-up, compared to sham rTMS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| tolerability and feasibility of administering rTMS, alcohol use pattern post-intervention. |
baseline, post-treatment, one-month, three-month and six-month follow-up |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/11/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
High-frequency rTMS will be applied over the right prefrontal cortex (rPFC). Alcohol craving measured using the Alcohol Craving Questionnaire (ACQ)-SF-R, tolerability and feasibility of administering rTMS and Alcohol use patterns, including abstinence duration, and relapse episodes via Time Line Follow Back method- alcohol (TLFB- Alcohol) will be assessed across five timepoints: baseline, post-treatment, one-month, three-month and six-month follow-up, compared to sham rTMS. |