Vagus nerve stimulation in Parkinson's disease

Phase 3

Completed

• Conditions: Idiopathic Parkinson's disease; Nervous System Diseases; Parkinson's Disease

• Registration Number: ISRCTN14797144
• Lead Sponsor: Institute of Neurosciences Kolkata

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34045464/ (added 10/02/2022) 2024 Results article in https://doi.org/10.3389/fnagi.2023.1331575 (added 22/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-01-30
• Study Start: 2020-05-11
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Patients with PD and FOG
2. Age ranging from 30-80 years
3. Can walk independently at a stretch for at least 30 meters without support
4. PD patients were diagnosed as per UKPDS (full form) Brain Bank Criteria

Exclusion Criteria

1. Significant visual impairment
2. Coexisting local or systemic diseases (e.g. osteoarthritis, other neurological conditions) which is likely to affect walking
3. History of Deep Brain Stimulation surgery or cardiac pacemakers were also excluded to ensure safe use of nVNS
4. Metallic implant/ metal cervical spine hardware near the stimulation site
5. Known or suspected cardiovascular disease, uncontrolled hypertension, recent myocardial infarction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measured at baseline and 1 month<br>1. Two dimensional spatio-temporal gait parameters derived from GAITRite walkway<br>2. Motor function using UPDRS III scrore<br>3. Extent of freezing of gait estimated from post hoc video analysis and FOGQ score

Secondary Outcome Measures

Name	Time	Method
Measured at baseline and 1 month<br>1. Cognitive parameters assessed by MMSE, Mattis DRS scores<br>2. Severity of REM sleep behavior disorder from REM sleep behavior disorder screening questionnaire RBDSQ <br>3. Fear of fall by Fall Efficacy Scale <br>4. Peripheral biomarkers from serum sample (TNF- Alpha, IL-6, IL 10, reduced glutathione, superoxide dismutase)