| CTRI Number |
CTRI/2025/10/096401 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Magnetic Brain Stimulation to Reduce Freezing of Gait in Parkinson’s Disease |
|
Scientific Title of Study
|
Effect of Repetitive Transcranial Magnetic Stimulation on Freezing of gait in Parkinson’s patients a Randomized 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 Sanjeev Kumar Bhoi |
| Designation |
Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room number 237 Neurology OPD AIIMS Bhubaneswar Odisha Sijua, patrapada, bhubaneswar Khordha ORISSA 751019 India AIIMS BBSR
Khordha
ORISSA
751019
India
Khordha
ORISSA
751019
India |
| Phone |
9919787978 |
| Fax |
|
| Email |
bhoisanjeev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manya Jarani |
| Designation |
Senior Resident Neurology |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Neurology, 2nd floor, AIIMS Bhubaneswar Khordha ORISSA 751019 India
Khordha
ORISSA
751019
India
Khordha
ORISSA
751019
India |
| Phone |
8142366655 |
| Fax |
|
| Email |
dr.manyajarani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manya Jarani |
| Designation |
Senior Resident Neurology |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Neurology, 2nd floor, AIIMS Bhubaneswar Khordha ORISSA 751019 India
Khordha
ORISSA
751019
India
Khordha
ORISSA
751019
India |
| Phone |
8142366655 |
| Fax |
|
| Email |
dr.manyajarani@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubaneswar, Sijua, Patrapada, PO- Dumduma, Bhubaneswar. PIN- 751019 |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
Sijua, Patrapada, PO Dumduma, Bhubaneswar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Manya Jarani |
AIIMS Bhubaneswar |
Department of Neurology, Neurology OPD in 2nd floor and Emergency services in ground floor, AIIMS Bhubaneswar, Sijua, Patrapada, PO Dumduma, Bhubaneswar Khordha ORISSA
Khordha
ORISSA |
8142366655
dr.manyajarani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
repetitive transcranial magnetic stimulation (rTMS) |
Five daily therapy sessions will make up the treatment arm. In this investigation, 1200, 1 Hertz rTMS pulses at 80% of resting motor threshold intensity will make up one therapy session using actual rTMS. 1 train consists of 600 pulses with 5 seconds gap between each train (total duration of 10 minutes to
each hemisphere). 6 trains applied to both primary motor cortex for 2 days and cerebellum for 3 days with MEP recordings. |
| Comparator Agent |
Sham “rTMS” |
Sham rTMS uses a coil that emits no
magnetic field (0%intensity) but creates the same sound and tactile experience as the actual coil. The auditory and tactile stimulation frequencies and durations will be the same as in the actual intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. All Parkinson disease patients with Freezing of gait.
2. Compliance with the 2015 MDS version of the PD diagnostic criteria
3. Hoehn-Yahr stage (H-Y stage) : stage 3 or less
4.Mini-Mental State Examination (MMSE) more than or equal to 24 points
5.PD medication stabilized for more than 2 weeks and no change in medication regimen during the study period
6.Being available to cooperate in completing the rTMS treatment and symptom assessment. |
|
| ExclusionCriteria |
| Details |
1. Atypical parkinson’s disease
2. Patients with pregnancy, CLD, CKD, malignancy, severe hypertension, pacemaker or metallic implants, and history of seizures or structural brain lesions, advanced heart failure
3. Patients not providing consent for participation in study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Freezing of Gait (FOG) in Parkinson patients |
Baseline, 1 month and 3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MRI correlation in FOG Parkinson Patients |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
03/11/2025 |
| 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="0"
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
|
Freezing of gait (FOG) is a highly disabling motor symptom in Parkinson’s disease (PD), affecting approximately 32% of patients and contributing significantly to falls, injuries, and reduced quality of life (Giladi et al., 1992; Moore et al., 2007). Despite optimal pharmacologic and surgical treatments, such as levodopa therapy and deep brain stimulation, FOG often persists or worsens (Bloem et al., 2015; Xu et al., 2021). Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising non-invasive neuromodulation technique that may modulate motor networks involved in gait (Fregni & Pascual-Leone, 2007; Elahi et al., 2009). High-frequency rTMS targeting motor and supplementary motor areas has shown potential in improving motor function and reducing FOG severity (Chou et al., 2015; Zhu et al., 2015; Xie et al., 2020; Deng et al., 2022). However, the evidence remains limited due to small sample sizes and inconsistent protocols. This study aims to evaluate the efficacy of rTMS in managing FOG in PD through a rigorously designed clinical trial, potentially offering a novel therapeutic avenue for a symptom that currently lacks effective long-term treatment. |