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CTRI Number  CTRI/2019/11/021925 [Registered on: 07/11/2019] Trial Registered Prospectively
Last Modified On: 06/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Other 
Public Title of Study   Effect of Magnetic Stimulation in Parkinsons Disease 
Scientific Title of Study   Effect of Transcranial Magnetic Stimualtion on changes in Microel-Electrode Recording patterns patient with Parkinsons Disease undergoing Deep Brain Stimulation: A Randomized Sham Controlled Study. 
Trial Acronym  TMS-DBS-MER 
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinay Goyal 
Designation  Professor 
Affiliation  AIIMS 
Address  706 Dept of Neurology CN Center AIIMS

New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  drvinaygoyal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinay Goyal 
Designation  Professor 
Affiliation  AIIMS 
Address  706 Dept of Neurology CN Center AIIMS

New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  drvinaygoyal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vinay Goyal 
Designation  Professor 
Affiliation  AIIMS 
Address  706 Dept of Neurology CN Center AIIMS

New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  drvinaygoyal@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research Ansari Nagar,New Delhi-110029 
 
Primary Sponsor  
Name  ICMR 
Address  ICMR Ansari Nagar New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vinay Goyal  AIIMS Delhi  Dept of Neurology
New Delhi
DELHI 		 011026594210

drvinaygoyal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G20||Parkinsons disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Real TMS  10 Hz for 6 days 
Comparator Agent  Sham TMS  The settings being used during real stimulation will be mimicked minus the actual stimulation. Thus sham stimulation will be delivered using a seperate sham coil for 6 days. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  75.00 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 above 1 to 2.
3. PD patients between age 45 to 75 on stable medication for at least 30 days. 
 
ExclusionCriteria 
Details  1. Features suggestive of other causes of Parkinsonism/ Parkinson-plus syndromes;
2. History of ICSOL (intracranial space occupying lesion) or brain surgeries, significant headaches, epilepsy or seizure disorder, mass lesions, or major head trauma leading to loss of consciousness of any length;
3. Family (1st degree relatives) history of epilepsy;
4. Presence of contraindications for functional magnetic resonance imaging (fMRI) like metal implants, and claustrophobia;
5. History of schizophrenia, schizoaffective disorder, other psychosis, rapid-cycling bipolar illness, alcohol/drug abuse within the past year;
6. Need for rapid clinical response due to conditions such as psychosis, or suicide tendency;
7. Patients with uncontrolled hypertension and diabetes and other uncontrolled medical illness. Patients with hypertension or diabetes would be included only if they are stable on medication for last six months. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
UPDRS, PDQ 39, LED,   Day 1 and Day 6  
 
Secondary Outcome  
Outcome  TimePoints 
MER  During Scheduled DBS surgery 
resting fMRI  Day 1 and Day 6  
 
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)   12/11/2019 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   rTMS is known to have neuromodulatory effects in Parkinson’s Disease but the mechanisms by which the motor benefits are incurred largely remain obscure. The objective of this study is to understand the cortico-subcortical plasticity with resting fMRI and Microelectrode Recording (MER) in patients with Parkinson’s Disease (PWP). This study thus involves modulating the motor cortical areas and observe the clinical and imaging outcome and attempt to correlate with subcortical MER pattern. The subcortical MER patterns would provide a measure of status of subcortical modulation by cortical rTMS. This may provide an insight into mechanisms of rTMS palsticity. The PWP will be divided into 2 groups and clinical, motor and imaging outcomes shall be observed before and after rTMS protocol. Both the group subjects would then undergo routine Deep Brain Stimualtion surgery during which the MER will be recorded. MER will be assessed between groups with real and sham rTMS. Any changes in the MER patterns will be correlated with the changes in clinical and resting state fMRI; thus providing insight into the possible mechanisms of action rTMS in producing motor benefits. 
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