| CTRI Number |
CTRI/2017/07/009064 [Registered on: 17/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of transcranial magnetic stimulation in Parkinsons Disease |
|
Scientific Title of Study
|
A randomized investigation of role of repetetive trans-cranial magnetic stimulation in parkinsons disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Bhat |
| Designation |
PhD student |
| Affiliation |
Dept. Of Neurology, AIIMS, Delhi |
| Address |
Priyanka Bhat,
PhD Scholar,
702(0ffice),
7th Floor,
CardioNeuroCentre,
All India Institute of Medical Sciences.
New Delhi-110029
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
bhatpriyanka84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka Bhat |
| Designation |
PhD student |
| Affiliation |
Dept. Of Neurology, AIIMS, Delhi |
| Address |
Priyanka Bhat,
PhD Scholar,
702(0ffice),
7th Floor,
CardioNeuroCentre,
All India Institute of Medical Sciences.
New Delhi-110029
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
bhatpriyanka84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Bhat |
| Designation |
PhD student |
| Affiliation |
Dept. Of Neurology, AIIMS, Delhi |
| Address |
Priyanka Bhat,
PhD Scholar,
702(0ffice),
7th Floor,
CardioNeuroCentre,
All India Institute of Medical Sciences.
New Delhi-110029
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
bhatpriyanka84@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, New Delhi, 110029,
India |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
All India Institute Of Medical Sciences, New Delhi, 110029,
India |
| 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 |
| CO Prof Vinay Goyal |
All India Institute Of Medical Sciences, New DELHI |
Room No 706,
C/O Prof. Vinay Goyal
Department of Neurology
CN Centre
AIIMS-110029
South
DELHI |
26594210
drvinaygoyal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Parkinsons Disease, (1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Real TMS |
During the Second month the patients would be subjected to REAL stimulation (using the real coil for TMS). |
| Comparator Agent |
Sham TMS |
During the first month the patients would be subjected to SHAM (placebo) stimulation (using the sham coil for TMS). |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of clinically definite PD, defined by UKPD brain bank clinical and diagnostic criteria. With presence of at least 1 out of 3 cardinal motor features of PD (resting tremor, rigidity, and postural impairment like bradykinesia);
2. PD patients of both gender with H&Y stage from 1 to 3.
3. PD patients between age 45 to 85 on stable medication for at least 30 days.
|
|
| ExclusionCriteria |
| Details |
Subjects with any other neurological, psychiatric co-morbidities were excluded from the study. Hypertensives and diabetics were included only if they were stable on antihypertensives and oral hypoglycaemics for past 6 months from the time of enrollment. Also subjects with any ferromagnetic implants or dental fillings were excluded so were the subjects who were eligible for deep brain stimulation (DBS) and were scheduled to undergo surgery in next 6 months. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
i. To compare the status of cortical plasticity between all the three treatment groups (M1, PM, SMA) using fMRI and FDG-PET.
ii. To compare the clinical condition of the patients in the three treatment groups on the basis of UPDRS, H & Y scale, PDQ-39, HAM-A, HAM-D, HADS and CGI.
iii. To compare the motor performance of the patient using Purdue peg-board test, and Timed motor tests.
|
Baseline 0 day
Post Sham at 4th week
Post Real at 8th week
[Baseline:-After recruitment
Post-Sham:-After 4 sessions of Sham TMS
Post-Real:- After 4 sessions of Real TMS.]
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the clinical condition of the patients in the three treatment groups on the basis of UPDRS, H & Y scale, PDQ-39, HAM-A, HAM-D, and CGI.
2.To compare the motor performance of the patient using Purdue peg-board test, and Timed motor tests.
|
Baseline 0 day
Post Sham at 4th week
Post Real at 8th week
[Baseline:-After recruitment
Post-Sham:-After 4 sessions of Sham TMS
Post-Real:- After 4 sessions of Real TMS.] |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
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)
|
17/05/2014 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized investigation to understand the role of repetetive Transcranial Magnetic stimulation patients with Parkinsons Disease. Various cortical areas are implicated in the pathophysiology of parkinsons disease namely primary motor area, Premotor area, supplementary motor area. In this study we modulated these areas with Transcranial Magnetic Stimulation and assessed the outcomes with fMRI, Clinical and motor scales. This is a single blinded sham controlled investigation. The outcomes were assessed at baseline, 4 weeks, 8 weeks. |