| CTRI Number |
CTRI/2024/01/061590 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Examining the Impact of Rapid Transcranial Magnetic Stimulation (rTMS) on Alleviating Depressive Episodes |
|
Scientific Title of Study
|
"A Clinical Study on the Effectiveness of Accelerated Transcranial Magnetic Stimulation (TMS) in the Treatment of Depressive Episode." |
| 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 Niharika H S |
| Designation |
Junior resident |
| Affiliation |
Karnataka Institute of Medical Sciences Hubli |
| Address |
Number 15,Ground floor Department of psychiatry, Karnataka Institute of Medical Sciences, Vidyanagar, Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
8277099089 |
| Fax |
|
| Email |
hs.niharika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Desai |
| Designation |
Professor and Head of Department |
| Affiliation |
Karnataka Institute of Medical Sciences Hubli |
| Address |
Numner 15,Department of Psychiatry, office - ground floor, Karnataka Institute of Medical Sciences
Dharwad
KARNATAKA
580021
India |
| Phone |
9448468311 |
| Fax |
|
| Email |
maheshsridesai@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niharika H S |
| Designation |
Junior resident |
| Affiliation |
KIMS Hubli |
| Address |
Number 15, first floor, Department of psychiatry, Karnataka Institute of Medical Sciences
Dharwad
KARNATAKA
580021
India |
| Phone |
8277099089 |
| Fax |
|
| Email |
hs.niharika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute of Medical Sciences, Hubli |
|
|
Primary Sponsor
|
| Name |
KIMS Hubli |
| Address |
KIMS HUBLI KARNATAKA |
| 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 NIHARIKA H S |
Karnataka Institute of Medical Sciences |
Seminar room, First floor, Department of Psychiatry, Karnataka Institute of Medical Sciences, Hubli
Dharwad
KARNATAKA |
8277099089
hs.niharika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute of Medical Science Hubballi Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
TRANSCRANIAL MAGNETIC STIMULATION |
THETA BURST TMS WILL BE APPLIED
Stimulus amplitude - 120 percent
Bursts frequency in train - 5 Hz
Pulses frequency in burst - 50 Hz
Bursts in train - 10
Pulses in burst - 3
number of trains - 60
intertrain interval - 8s
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing and able to give written informed consent.
Patients of all ages 18 to 60 diagnosed with mild depressive episode and moderate depressive episode for the first time, being treated under psychiatry department KIMS Hubli.
|
|
| ExclusionCriteria |
| Details |
Patients who refuse to consent for the study
Patients less than 18 years or above 60 years
Patients with severe depressive episode
Medical comorbidities such as epilepsy, vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, severe or recent heart disease
Pregnancy
 Patients who have implanted ferromagnetic devices or other magnetic-sensitive metal
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Remission of Depression will be assessed |
Remission will be assessed at the end of 5th session and 10th session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| How long the remission lasts will be assessed |
The patient will be assessed one month after the initial session |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
20/01/2024 |
| 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="0"
Months="3"
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 will be a longitudinal interventional study that involves patients satisfying all the inclusion criteria.
All patients who match the inclusion criteria will be assessed for severity of depression according to ICD 10 criteria.
Patients having first episode mild and moderate depressive episode will be treated according to the standard accelerated Theta Burst Stimulation Protocol
Patients will be assessed with HDRS scale before the treatment and after 5th session and at the end of final session.
All patients will receive the accelerated iTBS protocol for depression which consists of three magnetic pulses delivered 20 ms apart and repeatedly delivered every 200 ms resulting in a 5 Hz theta rhythm over the left DLPFC area.
Intensity will be set to 120% motor threshold (MT), and a total of 3600 pulses will be delivered per day, two sessions of 2000 pulses each with 30 min interval lasting roughly 13 min. Total 20 sessions on 10 consecutive days.
|