| CTRI Number |
CTRI/2023/01/048707 [Registered on: 03/01/2023] Trial Registered Prospectively |
| Last Modified On: |
23/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Transcranial Magnetic stimulation] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Repetitive transcranial stimulation (rTMS) in Treatment resistant obsessive compulsive disorder |
|
Scientific Title of Study
|
Role of rTMS as an adjunctive treatment in treatment resistant OCD :A randomized double blind and sham control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kartikeya Singh |
| Designation |
Asst Professor |
| Affiliation |
Command Hospital, Kolkata |
| Address |
Dept of Psychiatry,
Command hospital,
New alipore,
Kolkata
Kolkata
WEST BENGAL
700027
India |
| Phone |
9816683476 |
| Fax |
|
| Email |
kramansingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kartikeya Singh |
| Designation |
Asst Professor |
| Affiliation |
Command Hospital, Kolkata |
| Address |
Dept of Psychiatry,
Command hospital,
New alipore,
Kolkata
Kolkata
WEST BENGAL
700027
India |
| Phone |
9816683476 |
| Fax |
|
| Email |
kramansingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kartikeya Singh |
| Designation |
Asst Professor |
| Affiliation |
Command Hospital, Kolkata |
| Address |
Dept of Psychiatry,
Command hospital,
New alipore,
Kolkata
Kolkata
WEST BENGAL
700027
India |
| Phone |
9816683476 |
| Fax |
|
| Email |
kramansingh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Kartikeya R Singh |
| Address |
Department of Psychiatry Command hospital
New alipore
Kolkata 700027 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Col Dr VS Chauhan |
1. Command hospital |
Dept of psychiatry
Kolkata
WEST BENGAL |
9971224694
vinaychauhan2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F422||Mixed obsessional thoughts and acts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transcranial magnetic stimulation |
Coil for magnetic stimulation for 2 weeks |
| Comparator Agent |
Transcranial magnetic stimulation |
Sham coil not giving magnetic stimulation for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex aged between 18 to 60 years.
Diagnosed cases of treatment resistant Obsessive compulsive disorder. Normotensive patients.
Age range:- 18- 60 years
Patients who gave written informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate in the study or dropped out during study period.
Current neurological or any comorbid psychiatric disorder.
History of epilepsy, significant head injury, drug abuse or any neurosurgical procedure, hypertension.
Subjects positive for TMS Adult Safety Screen (TASS) including individuals with cardiac pacemaker or metal in head.
Subjects who received ECT (Electro Convulsive Therapy) or antipsychotics in past 6 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of rTMS (Repetitive transcranial magnetic stimulation) as an adjunctive treatment modality in patients of treatment resistant OCD (Obsessive Compulsive Disorder
|
Baseline and 2 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of active low frequency rTMS as an adjunctive treatment with the sham rTMS in cases of treatment resistant OCD |
To compare the efficacy of active low frequency rTMS as an adjunctive treatment with the sham rTMS in cases of treatment resistant OCD after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
20/01/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Repetitive transcranial magnetic stimulation is FDA approved treatment for Obsessive compulsive disorder. As the disorder causes significant distress and dysfunction study has not been done for resistant cases of OCD wich account for 30 % of total cases.This creates a gap in the management of resistant cases of OCD. Our study is aimed at adjunctive treatment of resistant cases of OCD where the medications will not be changed during course of therapy and results will be analysed subsequently. |