| CTRI Number |
CTRI/2024/05/068023 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [TRANSCRANIAL MAGNETIC STIMULATION] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Assess The Role of adjuvant intermittent theta burst stimulation over the right Dorsolateral Prefrontal Cortex in patients with alcohol use disorder compared with sham stimulation |
|
Scientific Title of Study
|
Role of adjuvant Intermittent Theta Burst stimulation over right dorsolateral prefrontal cortex in patients with alcohol use disorders , a randomized double blind 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 Suvrangshu Chattaraj |
| Designation |
Junior Resident |
| Affiliation |
Institute of Psychiatry A centre of excellence, IPGMER and SSKM hospital |
| Address |
7 DL KHAN ROAD INSTITUTE OF PSYCHIATRY , A CENTRE OF EXCELLENCE (IOPCOE) , IPGMER AND SSKM HOSPITAL
DEPARTMENT OF PSYCHIATRY
Kolkata
WEST BENGAL
700025
India |
| Phone |
9800763248 |
| Fax |
|
| Email |
suvlu1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NIKHILES MANDAL |
| Designation |
Head of the Department, Department of Psychiatry |
| Affiliation |
Maharaja Jitendra Narayan Medical College and Hospital |
| Address |
MAHARAJA JITENDRA NARAYAN MEDICAL COLLEGE AND HOSPITAL
VIVKENANDA STREET , PILKHANA ,
COOCHBEHAR WEST BENGAL
Koch Bihar
WEST BENGAL
736101
India |
| Phone |
9531546172 |
| Fax |
|
| Email |
nikhilesmandal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suvrangshu Chattaraj |
| Designation |
Psychiatry Junior Resident |
| Affiliation |
Institute of Psychiatry, A centre of excellence (IOP-COE) , IPGMER and SSKM hospital |
| Address |
7 DL KHAN ROAD INSTITUTE OF PSYCHIATRY , A CENTRE OF EXCELLENCE , IOPCOE, IPGMER AND SSKM HOSPITAL, DEPARTMENT OF PSYCHIATRY
Kolkata
WEST BENGAL
700025
India |
| Phone |
9800763248 |
| Fax |
|
| Email |
suvlu1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Psychiatry, A centre of excellence (IOP-COE) , IPGMER and SSKM hospital, Kolkata 700025, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Institute Of Psychiatry A Centre Of ExcellenceIOPCOE |
| Address |
7 Dl Khan Road , Kolkata 700025, West Bengal , 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 SUVRANGSHU CHATTARAJ |
Institute Of Psychiatry ,A Centre Of Excellence. (IOP-COE) |
OPD and INDOOR of Department of Psychiatry (IOPCOE)
7 Dl Khan Road ,
Kolkata 700025
West Bengal
India
Kolkata
WEST BENGAL |
9800763248
suvlu1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R RESEARCH OVERSIGHT COMMITTEE INSTITUTIONAL ETHICS COMMITTEE |
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 |
INTERMITTENT THETA BURST STIMULATION |
Intermittent Theta Burst stimulation is applied over Right Dorsolateral Prefrontal Cortex in patients with alcohol use disorder , twice daily sessions 5 days a week for a total of 20 sessions. |
| Comparator Agent |
SHAM stimulation |
Sham stimulation is applied over Right Dorsolateral Prefrontal Cortex, twice daily sessions 5 days a week for a total of 20 sessions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. AGE OF PATIENT 18 TO 65 YRS IF AGE OF EITHER GENDER
2. Subjects who have given consent for participation in the study
3. Subjects meeting DSM V criteria for alcohol use disorder, not meeting criteria for dependence to other substances except for nicotine and caffeine.
4. Subjects whose last intake of alcohol will be within the past 2 weeks.
5. Subjects who are not suffering from psychosis , not in acute withdrawal state with CIWA AR score less than 10 and not suffering from delirium.
|
|
| ExclusionCriteria |
| Details |
1. Cognitive impairment
2. Current DSM V diagnosis of major depression , schizophrenia or any other psychotic disorder, or any other comorbid psychiatric illness .
3. Standard rTMS contraindications like history of epilepsy, metal implants near the head or in any part of the body , history of neurosurgical operations , pacemaker implant
4. Concurrent use of medications or drugs that are known to reduce the seizure threshold.
5. Pregnancy.
6. Subjects with intellectual disabilities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect of intermittent theta burst stimulation in patients with alcohol use disorder on craving |
DAY 7, 2 WEEKS ,4 WEEKS , 12 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time to relapse |
within 3months of intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/06/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
TOPIC OF RESEARCH-“ROLE OF ADJUVANT INTERMITTENT THETA BURST STIMULATION OVER RIGHT DORSOLATERAL PREFRONTAL CORTEX IN PATIENTS WITH ALCOHOL USE DISORDERS: A RANDOMIZED DOUBLE BLIND SHAM CONTROLLED TRIAL†OBJECTIVE-To assess the role of adjunctive intermittent theta burst stimulation over the right dorsolateral prefrontal cortex in patients with alcohol use disorders compared with sham stimulation over the right dorsolateral prefrontal cortex . METHODOLGY:A randomized, double blind sham controlled trial will be carried out in 60 patients diagnosed with alcohol use disorders and fulfilling the inclusion and exclusion criteria, and upon receiving the informed consent will be admitted in our inpatient department and undergo detoxification procedure after which, these patients will be randomly allocated by computer generated randomization tables into 2 groups . Patients will be unaware of the type of RTMS they will receive .During the course of intervention with transcranial magnetic stimulation, patients will receive evidence based psychotherapy which will be provided by a team of clinical psychologists, who will be unaware regarding any details of Rtms , and they will be provided symptomatic treatment with medicines like paracetamol and benzodiazepines on sos basis .30 patients will be receiving adjunctive active treatment with intermittent theta burst stimulation and 30 patients will be receiving adjunctive sham stimulation. Handedness of the patient will be ascertained. Motor threshold will be measured as per protocol and subsequent intermittent theta burst stimulation or sham stimulation will be delivered over the right dorsolateral prefrontal cortex region twice daily on weekdays for 10 days, a total of 20 sessions. The baseline assessment of alcohol use and pattern , craving will be done prior to active or sham stimulation and after 7 days, 14 days , 1 month and 3 months of intervention by another psychiatrist who will not be involved in administration of RTMS. Blood test for Mean corpuscular volume and Gamma Glutamyl Transferase, Liver function tests, Uric acid, will be done on admission and at 1 month and 3 months after intervention . EXPECTED OUTCOME-Adjunctive intermittent theta burst stimulation over the right dorsolateral prefrontal cortex in the patients with alcohol use disorders after will reduce craving ,the amount of daily intake of alcohol, and days until relapse , as compared to sham stimulation . |