Effect of Vagus Nerve Stimulation on Levodopa Induced Dyskinesia- A randomized trial
Phase 3
- Conditions
- Health Condition 1: G20- Parkinsons disease
- Registration Number
- CTRI/2021/03/032142
- Lead Sponsor
- Institute of Neurosciences Kolkata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Male or female aged 40-80 years.
clinical diagnosis of PD according to the UK Parkinsonâ??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 Parkinsonâ??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 Parkinsonâ??s Disease rating Scale part IV/UPDRS part IV). <br/ ><br>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 <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 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) <br/ ><br>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 visitsTimepoint: 15days