Effect of Vagus Nerve Stimulation on Levodopa Induced Dyskinesia- A randomized trial

Phase 3

Not yet recruiting

• Conditions: Parkinsons disease,

• Registration Number: CTRI/2021/03/032142
• Lead Sponsor: Institute of Neurosciences Kolkata

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-03-18
• Study Start: 2021-03-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	15days treatment and 15days of washout
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of Neurosciences Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Institute of Neurosciences Kolkata

🇮🇳Kolkata, WEST BENGAL, India

Dr Supriyo Choudhury

Principal investigator

9433106238

choudhurydrsupriyo@gmail.com