FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/03/032142 [Registered on: 19/03/2021] Trial Registered Prospectively
Last Modified On: 18/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effect of Vagus Nerve Stimulation on Levodopa Induced Dyskinesia- A randomized trial 
Scientific Title of Study   The effect of non-invasive cervical vagus nerve stimulation on Levodopa induced Dyskinesia  
Trial Acronym  VNS in Dyskinesia 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hrishikesh Kumar 
Designation  Vice Chairman, HOD Neurology, Director of Research 
Affiliation  INSTITUTE OF NEUROSCIENCES KOLKATA 
Address  185/1 AJC Bose Road Kolkata 700017 Institute of Neurosciences Kolkata Department of Neurology 9th Floor Research room 1

Kolkata
WEST BENGAL
700017
India 
Phone  9874645445  
Fax    
Email  rishi_medicine@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Supriyo Choudhury 
Designation  Assistant Director of Research  
Affiliation  Institute of Neurosciences Kolkata 
Address  185/1,A.J.C Bose Road, Kolkata-700017 Department of Neurology 9th Floor Research room 1

Kolkata
WEST BENGAL
700017
India 
Phone  9433106238  
Fax    
Email  choudhurydrsupriyo@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Supriyo Choudhury 
Designation  Assistant Director of Research  
Affiliation  Institute of Neurosciences Kolkata 
Address  185/1, A.J.C Bose Road Kolkata- 700017 Department of Neurology 9th Floor Research room 1

Kolkata
WEST BENGAL
700017
India 
Phone  9433106238  
Fax    
Email  choudhurydrsupriyo@gmail.com  
 
Source of Monetary or Material Support  
Electrocore LLC (USA) electroCore, Inc. 200 Forge Way - Suite 205 Rockaway, New Jersey 07866, USA 
Institute of Neurosciences Kolkata 
 
Primary Sponsor  
Name  Institute of Neurosciences Kolkata 
Address  185/1 AJC Bose Road Kolkata 700017 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
Electrocore Both treatment and sham device will be provided by them  electroCore, Inc. 200 Forge Way - Suite 205 Rockaway, New Jersey 07866, USA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Supriyo Choudhury  Institute of Neurosciences Kolkata  185/1, A.J.C Bose road, Kolkata- 700017 Department of Neurology 9th Floor research room 1
Kolkata
WEST BENGAL 		 9433106238

choudhurydrsupriyo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Institute of Neurosciences Kolkata  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 
Comparator Agent  Sham nVNS device  The sham device will also be manufactured and supplied by electrocore LLC (USA).The patients will hold the sham stimulator after application of conducting gel on the left cervical region over the surface of vagus nerve. sham device will produce a superficial sensation but does not stimulate the vagus nerve. It will be given 3 pre-specified times every day like treatment device. 
Intervention  Treatment nVNS device  The devices will be provided gratis and without restriction by electrocore LLC (USA),it will delivers a kilo hertz frequency sinusoidal electrical stimulation. The patients will hold the stimulator after application of conducting gel on the left cervical region over the surface of vagus nerve. Each treatment will comprise two 2-minute stimulations delivered 5–10 minutes apart to the left side of the neck at 3 pre-specified times every day. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Male or female aged 40-80 years.
clinical diagnosis of PD according to the UK Parkinson’s Disease Society Brain Bank criteria, which included the presence of two of the three cardinal signs (tremor at rest, bradykinesia, and rigidity)age at onset >40 years, active and longitudinal follow-up >4 years, Patient is on stable dose of L-Dopa from last 15days. 
 
ExclusionCriteria 
Details  Patients with history of neurological conditions other than Parkinson’s disease
Co-morbidities including systemic or local inflammatory disorders
Patients with a permanent cardiac pacemaker will be excluded from the study
Patient with significant ECG abnormality
Any uncontrolled systemic disease
patient likely to noncompliant 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of 15 days treatment with noninvasive cervical VNS compared to sham stimulation on levodopa induced dyskinesia (LID) through clinical rating scales (abnormal involuntary movement scale,dyskinesia rating scale(UDysRS),Unified Parkinson’s Disease rating Scale part IV/UPDRS part IV).
To assess the effect of 15days treatment with noninvasive cervical VNS compared to sham stimulation on mean duration of LID as assessed through patient diary



 		 15days treatment and 15days of washout 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of 15days treatment with noninvasive cervical VNS compared to sham stimulation on overall cognitive changes and motor symptoms of PD patients through clinical rating scale (FAB,UPDRS part I to IV and Total)
To assess the cardiac safety of 15days treatment with noninvasive cervical VNS compared to sham stimulation through recording of resting blood pressure, pulse and resting electrocardiogram (ECG) at all visits 		 15days 
 
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 
Date of First Enrollment (India)   26/03/2021 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Noninvasive vagus nerve stimulation (nVNS) is an approved treatment in a variety of neurological disorders and has been recently shown efficacy in Parkinson’s disease (PD) at preclinical stage. The mechanism of nVNS still unclear but it is found to have anti-inflammatory action (Boi et al., 2019). It can also activate certain brain regions including but not limited to locus coeruleus (LC).
The treatment for disabling motor complication of PD, like L-dopa induced dyskinesia (LID) is often unsatisfactory. The pathophysiology of LID is still obscure but, LC has been thought to be one of the major anatomical substrates for it.
Additionally, neuroinflammation is upregulated in LID. Taken together we speculate, nVNS could be an effective treatment option for LID. Hence, we plan to conduct a clinical trial to confirm the effect of nVNS on PD patients with LID.
Overall, nVNS has huge potential in preventing and treating various non-communicable neurological disorders including PD.
 
Close