Effect of taVNS of Brainstem Activation in Early and Late Parkinson's Disease Patients - an fMRI Study
Launched by UNIVERSITY OF LJUBLJANA · Jul 20, 2023
Trial Information
Current as of May 13, 2025
Completed
Keywords
ClinConnect Summary
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. The Nemos® electrode for taVNS will be positioned in the left cymba conchae with the following parameters: square-shaped pseudobiphasic pulse, interpulse duration 80μs, pulse width 300μs. taVNS25 will be applied at 25Hz and taVNS100 will be applied at 100Hz. The sensory threshold will be assessed for each frequency and in the MRI scanner a pulse intensity of 0,1mA above the perceptual threshold ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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...).
About University Of Ljubljana
The University of Ljubljana, established in 1919, is Slovenia's largest and most prestigious institution of higher education and research. Renowned for its commitment to academic excellence and innovation, the university plays a pivotal role in advancing scientific knowledge and healthcare practices. As a clinical trial sponsor, the University of Ljubljana leverages its extensive expertise and resources across a diverse range of medical disciplines to facilitate robust research initiatives aimed at improving patient outcomes and advancing medical science. With a focus on ethical standards and collaboration, the university is dedicated to fostering a dynamic research environment that supports groundbreaking studies and contributes to the global understanding of health and disease.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ljubljana, , Slovenia
Patients applied
Trial Officials
Andrej Vovk, PhD
Principal Investigator
Medical Faculty, University of Ljubljana
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported