| CTRI Number |
CTRI/2025/10/096608 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effects of magnetic stimulation over scalp in improving the symptoms in parkinsons disease |
|
Scientific Title of Study
|
To compare the Effectiveness of Low-Frequency Repetitive Transcranial Magnetic Stimulation (LF-r TMS) vs High-Frequency Repetitive Transcranial Magnetic Stimulation (HF-r TMS)in the Rehabilitation of Parkinsons Disease – an observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lt Col Dr Mohit Kataruka |
| Designation |
Assosciate Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
Room 115, First Floor, OPD Building, AIIMS Kalyani.
Nadia
WEST BENGAL
741245
India |
| Phone |
08729912916 |
| Fax |
|
| Email |
mohit.pmr@aiimskalyani.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Souvik Bhattacharjee |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Kalyani |
| Address |
Room 117, First Floor, OPD Building, AIIMS Kalyani.
Nadia
WEST BENGAL
741245
India |
| Phone |
7044544347 |
| Fax |
|
| Email |
bhattacharjeesouvik141@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Souvik Bhattacharjee |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Kalyani |
| Address |
Room 117, First Floor, OPD Building, AIIMS Kalyani.
Nadia
WEST BENGAL
741245
India |
| Phone |
7044544347 |
| Fax |
|
| Email |
bhattacharjeesouvik141@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Kalyani |
| Address |
NH 34 connector,Basantapur, Saguna, Kalyani, Nadia, West Bengal, 741245 |
| 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 |
| Souvik Bhattacharjee |
AIIMS kalynai |
Department of Physical Medicine and Rehabilitation ,Room 117, First Floor, OPD Building, AIIMS Kalyani.
NH-34 Connector, Basantapur, Saguna, Kalyani, Nadia, West Bengal, 741245
Nadia
WEST BENGAL |
7044544347
bhattacharjeesouvik141@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani |
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 |
| Comparator Agent |
High frequency stimulation |
Group B—intensity: 5Hz, 10 pulses over 10 seconds, for a total of 150 pulses |
| Intervention |
Low frequency stimulation |
Group A—intensity: 1Hz, 100% RMT, 12 trains with 50 magnetic pulses on each train, a total of 600 pulses per session. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. PD symptomatic for more than 6 months |
|
| ExclusionCriteria |
| Details |
1. Stroke
2. Intracranial metal implant
3. Pacemakers
4. Medication pump implant
5. Cochlear implant
6. History of brain surgery
7. History of seizure or epilepsy
8. Family history of epilepsy
9. Substance abuser
10. History of head trauma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale(BBS) |
At baseline and after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Unified Parkinsons Disease Rating Scale (UPDRS) |
At baseline, after 2 weeks, 4 weeks and 8 weeks |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
11/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/11/2025 |
| 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 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
|
Parkinson’s disease (PD) is defined by a lack of dopamine, and substitution remains primary therapy, but the degeneration of nondopaminergic neurons progresses and leads to the emergence of symptoms refractory to conventional therapy. Among them, difficulties with gait and recurrent falls are common and cause disability in advanced PD. Transcranial magnetic stimulation (TMS), which, as a non-invasive brain stimulation (NIBS), is used in neurological and psychiatric conditions, especially in Alzheimer’s disease (AD), mild cognitive impairment (MCI), depression, and mental disease Cortical excitability of the primary motor cortex is altered in patients with Parkinson’s disease (PD). Therefore, modulation of cortical excitability by high-frequency repetitive transcranial magnetic stimulation (rTMS) of the motor cortex might result in beneficial effects on motor functions in PD.
|