Combining VNS With PT Interventions for Individuals With PD
Completed · Not applicable · Has a placebo group
Conditions studied: Parkinson Disease
In brief
The purpose of this study is to evaluate the combined effects of non-invasive neuromodulation (specifically transauricular Vagus Nerve Stimulation) with exercise interventions to improve physical function and quality of life in individuals with Parkinsons Disease.
Key facts
- Study ID
- NCT05871151
- Run by
- University of Alabama at Birmingham
- People needed
- 25
- Starts
- 2023-10-01
- Expected to finish
- 2024-12-01
- Last updated by the study team
- 2025-12-17
Who can join
Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of PD by a board-certified neurologist
- age between 35 and 80 years
- no walking aids
- stable medication 4 weeks prior to and during the study
- no falls in the past 6 months
- participant must have MD who is willing to provide oversight and approval for clinically defined OFF state
You may not qualify if…
- mild cognitive impairment (MoCA \<25)
- self reported depression
- antidepressive or antipsychotic medication
- participation in a VNS study in the past year
- disabling bradykinesia to ensure patients are able to participate in intensive physiotherapy (based on clinical impression and in accordance to UPDRS part III item 14 - to be administered in clinic)
- prior history of cardiovascular, neurological or musculoskeletal disorders known to interfere with testing PD features
- implanted medical device of any type
- history of seizures
- peripheral neuropathy including temporal mandibular disorders and Bells Palsy, and
- vasovagal syncope.
Where it is running
- WHARF — Birmingham, Alabama, United States
- UAB — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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