| CTRI Number |
CTRI/2019/11/021847 [Registered on: 04/11/2019] Trial Registered Prospectively |
| Last Modified On: |
14/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Repetitive transcranial magnetic stimulation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How effective is the Repetitive Transcranial Magnetic Stimulation (rTMS) in improving Daily Living, Behaviour and Cognitive ability of Parkinson disease Patients: A Randomized Controlled Trial |
|
Scientific Title of Study
|
To study the effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Activities of Daily Living, Behavioral and Cognitive ability (A-B-C) of Parkinson disease Patients through a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashima Nehra |
| Designation |
Professor |
| Affiliation |
Division of Clinical Neuropsychology, Neurosciences Centre, AIIMS, New Delhi |
| Address |
Room 718, 7th Floor, Clinical Neuropsychology, Neurosciences Centre, All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
ashimanwadhawan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashima Nehra |
| Designation |
Professor |
| Affiliation |
Division of Clinical Neuropsychology, Neurosciences Centre, AIIMS, New Delhi |
| Address |
Room 718, 7th Floor, Clinical Neuropsychology, Neurosciences Centre, All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
ashimanwadhawan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashima Nehra |
| Designation |
Professor |
| Affiliation |
Division of Clinical Neuropsychology, Neurosciences Centre, AIIMS, New Delhi |
| Address |
Room 718, 7th Floor, Clinical Neuropsychology, Neurosciences Centre, All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
ashimanwadhawan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology,
6th-8th Floor, Block 2 CGO Complex, Lodhi Road New Delhi - 110003,India |
|
|
Primary Sponsor
|
| Name |
Department of Biotechnology |
| Address |
Department of Biotechnology
Address: CGO Complex, Pragati Vihar, New Delhi, Delhi 110003 |
| Type of Sponsor |
Government funding agency |
|
|
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 Ashima Nehra |
All India Institute of Medical Sciences, New Delhi |
Division of Clinical Neuropsychology, Neurosciences Centre,
All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India.
New Delhi
DELHI |
9810882765
ashimanwadhawan@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences |
Approved |
| All India Institute of Medical Sciences |
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 |
Not Applicable |
Not Applicable |
| Intervention |
Repetitive Transcranial Magnetic Stimulation (rTMS) |
This intervention would include 2 seconds each pulse, using an intensity of 100% of motor threshold and 20 hz frequency at dorso lateral prefrontal cortex (DLPFC) for 10 days over a 2 week period while the rest of the protocol will be standardized according to IFCN guidelines, 2009 and lab conditions. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Consenting Individual
2. Patients diagnosed with idopathic Parkinson disease (As per UK Brain Bank Criteria)
3. Ability to sustain rTMS procedure for 2 weeks time period.
3. All education levels
4. Urban and rural
5. Right/left handedness
|
|
| ExclusionCriteria |
| Details |
• Those not consenting
• Any history of major psychiatric illness
• Acute head injury
• Patients with severe Depression on BDI-II (≥29)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Cognition and Behavioural domains of Parkinson disease Patients. |
baseline
1 month
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Parkinson Disease- Quality of Life- 39 |
Parkinson Disease- Quality of Life- 39 |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
04/11/2019 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Parkinsons Disease (PD) is the second most common neurodegenerative disorder and the most common movement disorder. The present research aims to study the efficacy of the Rtms using a neural navigator. This makes the work and therapeutic efficacy free from human error. Hence, if our research turns out to be positive at the completion of this project, then this program can be used for providing rTMS to patients suffering from Parkinson Disease along with other movement related disorders in order to improve their quality of life domains including cognition and behavioural aspect as they are found to be impaired which often gets under diagnosed and is found to have disabling effects on their lives. Hence, such treatment would help them restore optimal functional independence, moreover. It would also help in clinical and public health perspective. Since the existing management method (pharmacological) for various neurological disorders more often aims at relieving physical symptoms than neuropsychological symptoms. Hence such a study was planned where the quality of life is targeted for better community and social integration. |