| CTRI Number |
CTRI/2025/06/089336 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
22/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Which Brain Stimulation works better for severe Obsessive Compulsive Disorder? A Randomized Controlled Trial comparing two techniques. |
|
Scientific Title of Study
|
Effectiveness of Intermittent Theta Burst Stimulation versus standard High Frequency Transcranial Magnetic Stimulation in drug resistant Obsessive Compulsive Disorder patients : Non-Inferiority Randomised Control 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 Manisha Deo |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Science, Gorakhpur |
| Address |
Room number 219, 2th floor, Psyhchiatry OPD, AIIMS Gorakhpur, Kunraghat, Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8218511574 |
| Fax |
|
| Email |
dev.manisha473@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Prithviraj |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Science, Gorakhpur |
| Address |
Room number 234,Psychiatry OPD, 2nd Floor, AIIMS Gorakhpur, Kunraghat, Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9854019389 |
| Fax |
|
| Email |
manoprithv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Prithviraj |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Science, Gorakhpur |
| Address |
Room number 234,Psychiatry OPD, 2nd Floor, AIIMS Gorakhpur, Kunraghat, Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9854019389 |
| Fax |
|
| Email |
manoprithv@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science, Kunraghat, Gorakhpur, Uttar Pradesh, India. Pincode 273008 |
|
|
Primary Sponsor
|
| Name |
Dr Manisha Deo |
| Address |
Room number 219, 2nd floor, Psychiatry OPD, AIIMS Gorakhpur, Kunraghat, Gorakhpur, Uttar Pradesh, India. Pincode 273008 |
| 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 |
| Dr Manisha Deo |
All India Institute of Medical Science, Gorakhpur |
Room number 219,Psychiatry OPD, 2nd Floor, AIIMS Gorakhpur, Kunraghat, Gorakhpur
Gorakhpur
UTTAR PRADESH |
82185 11574
dev.manisha473@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, All India Institute of Medical Science, Gorakhpur, India-273008 |
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 |
Intermittent Theta Burst Transcranial Magnetic Stimulation |
Intermittent Theta Burst Stimulation involves using Cool DB80 coil to provide magnetic stimulation of 600 pulses per session delivered in 20 trains with 8 seconds inter train interval. Each train consists of 10 pulses with a repetition rate of 50 pulses per second lasting for a total duration of 3 minutes.
Area targeted will be ACC (Anterior Cingulate Cortex). 3 sessions will be given per day for a total of 30 sessions (5 days per week).
|
| Comparator Agent |
Standard High Frequency Transcranial Magnetic Stimulation |
Standard High Frequency Transcranial Magnetic Stimulation involves using Cool DB80 coil to provide magnetic stimulation of 2000 pulses per session delivered in 50 trains with 20 seconds inter train interval. Each train consists of 50 pulses with a repetition rate of 20 pulses per second lasting for a total duration of 18 minutes. Area targeted will be ACC (Anterior Cingulate Cortex). 1 session will be given per day for a total of 25 sessions (5 days per week). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Age 16 to 60 years
2 Patients meeting diagnostic criteria for OCD according to ICD 11 with YBOCS score of 15 out of 40
3 Patients with OCD meeting criteria of drug resistance defined as a patient showing less than 25 percent reduction in baseline YBOCS score to at least 2 SSRIs at maximum recommended doses for a trial duration of at least 12 weeks
4 Both male and females are included
5 Patient willing to provide written informed consent |
|
| ExclusionCriteria |
| Details |
1 Patients with seizure disorder
2 Patients with metallic implants
3 Patients with hearing impairments
4 Patients with brain injury
5 Patients with migraine or frequent complains of severe headache
6 Patients with stroke or history of cerebrovascular accident
7 Patients with co morbid psychiatric disorder except mild depression assessed by Hamilton Depression score of less than 17
8 History of substance abuse except tobacco or caffeine
9 Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Severity of OCD will be measured by Yale Brown Obsessive Compulsive Scale ,Clinical Global Impression, Dimensional Obsessive-Compulsive Scale and Hamilton Anxiety Rating Scale scores.
2. Number of missed sessions for each group and the reason for missed sessions will be assessed.
3. Treatment completion and dropout: In each group, the number of participants completing the study despite missed sessions and the number of participants who dropout will be determined. |
Baseline, day 12 , day 33 (for control arm only), follow up week 4 and week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Treatment emergent adverse events
|
For control group: Day 1,2,3,4,5,8,9,10,11,12,15,16,17,18,19,22,23,24,25,26,29,30,31,32,33, week 4 (post completion)
For intervention group: Day 1,2,3,4,5,8,9,10,11,12 , week 4 (post completion) |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="6"
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
|
This study is a randomized, outcome assessor blinded , parallel group, single center trial comparing the effectiveness of Intermittent Theta Burst Stimulation to standard High Frequency Transcranial Magnetic Stimulation in 56 patients with drug resistant Obsessive Complusive Disorder that will be conducted
in 1 center in India. The
primary outcome measures will be change in Yale Brown Obsessive Complusive scale, Clinical Global Impression, Dimensional Obsessive Compulsive Scale and Hamilton Anxiety Rating Scale scores at baseline, day 12 , day 33 for control arm, follow up week 4 and week 12. The
secondary outcomes will be treatment emergent adverse events after every TMS session. |