| CTRI Number |
CTRI/2025/12/099350 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of rTMS in treating depression in patients with parkinson’s disease |
|
Scientific Title of Study
|
A STUDY TO EVALUATE THE
EFFECT OF REPETITIVE
TRANSCRANIAL MAGNETIC
STIMULATION (rTMS) FOR
TREATMENT OF DEPRESSION IN
PERSONS WITH PARKINSON’S
DISEASE |
| 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 Nandini Sharma |
| Designation |
PG Resident |
| Affiliation |
ABVIMS & DR. RML Hospital New Delhi |
| Address |
Department of Psychiatry ABVIMS and Dr.RML Hospital New Delhi
New Delhi
DELHI
110001
India |
| Phone |
8901418859 |
| Fax |
|
| Email |
Sharmanandini256@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr.RML Hospital New Delhi |
| Address |
Department of Psychiatry ABVIMS and Dr.RML Hospital New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9313231020 |
| Fax |
|
| Email |
Gautamsharma@dr.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr.RML Hospital New Delhi |
| Address |
Department of Psychiatry ABVIMS and Dr.RML Hospital New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9313231020 |
| Fax |
|
| Email |
Gautamsharma@dr.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr RML Hospital New Delhi 110001 India |
|
|
Primary Sponsor
|
| Name |
Dr Nandini Sharma |
| Address |
ABVIMS and Dr RML Hospital New Delhi 110001 India |
| 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 Nandini Sharma |
ABVIMS and Dr RML Hospital New Delhi 110001 India |
Room number 10 Department of Psychiatry ABVIMS and Dr RML hospital New Delhi
Central
DELHI |
8901418859
Sharmanandini256@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee PGIMER Dr. RML Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F063||Mood disorder due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Repetitive transcranial magnetic Stimulation |
10 sessions of high frequency rTMS on left DLPFC will be applied |
| Intervention |
rTMS (Repetitive transcranial magnetic Stimulation) |
High frequency rtms will be used |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Participants diagnosed with parkinsons disease, scoreing more than 8 on HAMD and treatment non response with at least 1 antidepressant |
|
| ExclusionCriteria |
| Details |
Any comorbid active psychiatric disorder, implanted metal device in brain head cardiac pacemaker or prosthesis in inner ear, pregnant and active breastfeeding females, history of neuromodulation in past three months. history of psychosurgery, dementia with MOCA score of less than 24, known seizure disorder or brain tumour |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HAMD |
Day 0, 14, 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WHOQOL-BREF |
Day0, 14, 28 |
| Cognition using MOCA |
day 0, 14, 28 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
31/12/2025 |
| 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 Yet Recruiting |
| 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 titled as a study to evaluate the effect of repetitive transcranial magnetic stimulation for treatment of depression in persons with parkinsons disease is an inetrventional study to assess the efficacy of high frequency rTMS over left dorsolateral pre frontal cortex in depression in persons with parkinsons’s disease. Eligible participants will undergo 10 sessions of high frequency rTMS over left DLPFC and will be assessed using HAMD, WHOQOL-BREF and MOCA to assess depressive symptoms, overall quality of life and cognitive functions at baseline 2 weeks and 4 weeks. |