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

The effect of non-invasive cervical vagus nerve stimulation on Levodopa induced Dyskinesia - VNS in Dyskinesia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/032142

Enrollment

Registered

2021-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G20- Parkinsons disease

Interventions

Intervention1: 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. Th

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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). 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 Timepoint: 15days treatment and 15days of washout	—

Measure

Time frame

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). 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 Timepoint: 15days treatment and 15days of washout

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Secondary

Measure	Time frame
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 visitsTimepoint: 15days	—

Measure

Time frame

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 visitsTimepoint: 15days

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Countries

India

Contacts

Public ContactDr Supriyo Choudhury

Institute of Neurosciences Kolkata

choudhurydrsupriyo@gmail.com9433106238

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026