| CTRI Number |
CTRI/2024/12/077628 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of RTMS in anxiety spectrum disorders |
|
Scientific Title of Study
|
A Randomized Controlled Trial of Repetitive Transcranial Magnetic Stimulation for Anxiety Spectrum Disorders
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanya Dixit |
| Designation |
Post Graduate Resident |
| Affiliation |
Kalinga Institute Of Medical Sciences Hospital and College , Bhubaneswar. |
| Address |
Department of Psychiatry,
A BLOCK, Kalinga Institute Of Medical Sciences ,Kushabhadhra Campus 5, KIIT Road, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9096935806 |
| Fax |
|
| Email |
tanyadixitt234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. Ram Chandra Das |
| Designation |
Professor |
| Affiliation |
Kalinga Institute Of Medical Sciences Hospital and College , Bhubaneswar. |
| Address |
Department of Psychiatry,
A BLOCK, Kalinga Institute Of Medical Sciences ,Kushabhadhra Campus 5, KIIT Road, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8411044558 |
| Fax |
|
| Email |
r2cdpsy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanya Dixit |
| Designation |
Post Graduate Resident |
| Affiliation |
Kalinga Institute Of Medical Sciences Hospital and College , Bhubaneswar. |
| Address |
Department of Psychiatry,
A BLOCK, Kalinga Institute Of Medical Sciences, Bhubaneswar. ,Kushabhadhra Campus 5, KIIT Road, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9096935806 |
| Fax |
|
| Email |
tanyadixitt234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry,
A BLOCK, Kalinga Institute Of Medical Sciences, Kushabhadhra Campus 5, KIIT Road, Bhubaneswar.
PIN CODE- 751024
Country- India |
|
|
Primary Sponsor
|
| Name |
Tanya Dixit |
| Address |
QC 17 Campus 23 Shishu Vihar, Patia Bhubaneswar, PIN CODE - 751024. |
| 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 |
| Tanya Dixit |
KALINGA INSTITUTE OF MEDICAL SCIENCES COLLEGE AND HOSPITAL BHUBANESWAR |
Department of Psychiatry,
A BLOCK, Kalinga Institute Of Medical Sciences, Kushabhadhra Campus 5, KIIT Road, Bhubaneswar.
PIN CODE - 751024
Khordha
ORISSA |
9096935806
tanyadixitt234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE KALINGA INSTITUTE OF MEDICAL SCIENCES (KIMS) KIIT DEEMED-TO-BE-UNIVERSITY, BHUBANESWAR -751024 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
rTMS |
A transcranial magnetic stimulation system with a standard 70mm figure-of-eight coil will be utilized for administering rTMS. Frequency will be set at 10 Hz and delivering a total of 3000 pulses over non dominant dorsolateral prefrontal cortex.
Duration- 10 sessions
Frequency - 10 HZ |
| Comparator Agent |
Sham rTMS |
For sham rTMS, specially designed coils producing negligible brain magnetic induction will be applied over the left dorsolateral region with scalp electrodes mimicking sensations but no cortical modulation.
Frequency - 10 Hz for 10 sessions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Principal Diagnosis of Panic disorder, phobic disorder and GAD as per ICD 10 criteria.
2.Moderate to severe anxiety (HAM-A ≥20)
3.Along with pharmacotherapy (as per IPS guidelines) rTMS / Sham rTMS
|
|
| ExclusionCriteria |
| Details |
Current high suicide risk
Comorbid MDD, OCD, psychotic disorders, bipolar spectrum or substance use disorders
Neurological disorders like cerebrovascular disease or epilepsy
Patient on mood stabiliser,Medical comorbidities or pregnancy and Other contraindications to rTMS like pacemakers or head implants
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome measure is pre-post change in total HAM-A scores and asses efficacy as compared to sham stimulation |
At 2nd and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment response & remission rated |
Treatment response rate (≥50% HAM-A reduction), remission rate (HAM-A score ≤7), changes in WHODAS scores & frequency of adverse events at 2nd week |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
14/12/2024 |
| 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="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
|
Anxiety disorders are highly prevalent and
disabling conditions where existing first-line interventions have limited
efficacy and accessibility alongside side effects. Non-invasive brain
stimulation with rTMS represents a safe, well-tolerated alternative approach
that has shown initial promise but lacks adequately powered sham-controlled
evidence. The study aims to conclusively establish the efficacy, tolerability
and neurophysiological correlates of right prefrontal high-frequency rTMS in
adults with moderate to severe anxiety unresponsive to standard treatment. |