Status:
COMPLETED
Effect of taVNS of Brainstem Activation in Early and Late Parkinson's Disease Patients - an fMRI Study
Lead Sponsor:
University of Ljubljana
Collaborating Sponsors:
University Medical Centre Ljubljana
Conditions:
Parkinson Disease
Neurologic Disorder
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
This is a randomised, within-subject, double-blinded, placebo-controlled study to assess the fMRI correlates of central nervous system (CNS) response to taVNS in early vs late-stage Parkinsons disease...
Detailed Description
Each participant will complete 1 visit, where the investigators will first assess the MDS-UPDRS score, afther that the sesnsitivity threasholds for taVNS at 25Hz and taVNS at 100Hz will be assessed. T...
Eligibility Criteria
Inclusion
- diagnosis of Parkinson's disease according to the UK PD Society Brain Bank criteria
- ability to walk independently for at least 2 minutes
- cognitive impairment that might prevent cooperation during tests
- stable antiparkinsonian medications during the previous 1 month
Exclusion
- medication resistant rest tremor or dyskinesias
- history of seizures
- implanted medical devices or metal implants
- pregnancy
- claustrophobia
- fixed or severe kyphosis
- any conditions that would prevent our patients from lying still for 1 hour in a supine position (i.e. muscle pain, degenerative joint diseases…).
Key Trial Info
Start Date :
February 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05967598
Start Date
February 15 2023
End Date
September 29 2023
Last Update
October 17 2023
Active Locations (1)
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1
Neurology Department, UMC Ljubljana
Ljubljana, Slovenia, 1000