Status:
RECRUITING
Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
ETH Zurich (Switzerland)
Cereneo AG
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Parkinson's disease (PD) is a neurodegenerative disease that affects about 1% of the elderly population and accounts for substantial disability and health care costs. Disability is largely driven by ...
Eligibility Criteria
Inclusion
- Idiopathic Parkinson's disease with gait and postural stability deficits
- ≥18 years of age
- United Parkinson Disease Rating Scale (UPDRS) III gait scores 1-3
- UPDRS III postural instability scores 1-3
- Prescribed rehabilitation therapy at cereneo
- Informed consent as documented by signature
- Adjustments in dopaminergic medication and deep brain stimulation (DBS) to improve motor symptoms implemented to the current best possible extent
Exclusion
- Cognitive impairment, Montreal Cognitive Assessment (MoCa) \< 20
- Comprehensive aphasia precluding the understanding of study-related information
- Other neurological or medical condition that caused sustained clinically relevant gait and/or postural stability deficits
- Expected acute hospitalization during the training period
- History of a physical or neurological condition that interferes with study procedures
- Social and/or personal circumstances that interfere with the ability to return for therapy sessions and follow-up assessments
- Not capable of voluntary gait adaptation
- Patients taking benzodiazepines or Z-drugs that have a significant effect on sleep EEG
- Recent DBS implant (≤ 6 months)
- Inability to perform outcome assessments without walking aid
- Skin disorders/problems/allergies in face/ear area that could worsen with electrode application (e.g. nickel allergy)
Key Trial Info
Start Date :
May 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06608875
Start Date
May 16 2024
End Date
December 1 2026
Last Update
October 1 2024
Active Locations (1)
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1
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8091