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Not Yet Recruiting NCT07908498

Non-invasive Vagus Nerve Stimulation for Parkinson's Disease

Conditions: Idiopathic Parkinson Disease

Sex: All
Ages: 40 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Chinese University of Hong Kong

Summary

Although breakthroughs in the management of Parkinson's disease (PD) have emerged in recent decades resulting in better control in symptoms, majority of patients with PD are still living with various disabling motor and non-motor symptoms despite they are already receiving the best contemporary medical or surgical treatments available to them. There is obviously a need to develop additional treatment modality to further optimize the control of symptoms and/or slow the disease progression for patients having PD. Vagus nerve stimulation (VNS), a type of noninvasive brain stimulation is believed to modify brain rhythms by modulating the nucleus of the solitary tract and locus coeruleus and other regions known to play a role in gait. Moreover, VNS may modulate inflammatory pathways and reduce oxidative stress, making it a potential disease modifying treatment approach for neurodegenerative diseases linked to neuroinflammation such as PD Further study is warranted to explore the efficacy of non-invasive VNS for its effects on gait and other symptoms of PD as well as the anti-inflammatory effects.

Eligibility Criteria

Inclusion Criteria: 1. Idiopathic PD as defined by the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria 2. Age 40 - 75 years old 3. Presence of gait impairment as defined by any one of the below: a UPDRS Part 2 Item 15 (Walking) with a score of 2 b. UPDRS Part 3 Item 26 (leg Agility) with score of 2 or 3 c. UPDRS Part 3 Item 29 (Gait) with score of 1 or 2 4. Availability of a caregiver at home 5. Cantonese speaker Exclusion Criteria: 1. Patients with atypical parkinsonism (e.g., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy Bodies) 2. PD with dementia 3. PD patients with DBS in-situ 4. Severe PD with a Hoehn and Yahr staging of 4 or above 5. Low blood pressure with systolic of \< 110 mmHg or with postural hypotension as defined by a decrease in systolic and diastolic blood pressure by 20 mmHg and 10mmHg upon standing, respectively) 6. Cardiac pacemaker in-situ

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Source: ClinicalTrials.gov (NCT07908498). StuddyBuddy aggregates publicly available trial information.