StimuLOOP.PD – Sensory-Motor Precision Neuro-Rehabilitation through Personalized Stimulation Loops for Patients with Parkinson's
Summary description of the study
The aim of the study is to improve walking function in patients with Parkinson's. Specifically, we want to find out whether personalized rehabilitation training tailored to their individual needs and the reinforcement of learned skills during sleep can improve gait quality and mobility more quickly and sustainably. We hope to use this information to enable more effective rehabilitation for Parkinson's patients in the future.
(BASEC)
Intervention under investigation
In our study, there are two groups:
• Group 1 (control group) receives the intervention method of personalized rehabilitation without additional reinforcement of learned skills during sleep.
• Group 2 (experimental group) receives the intervention method of personalized rehabilitation with additional reinforcement of learned skills during sleep.
(BASEC)
Disease under investigation
Parkinson's with gait disturbance
(BASEC)
- Diagnosis of idiopathic Parkinson's syndrome - UPDRS III: postural instability score 1-3 - UPDRS III: gait score 1-3 (BASEC)
Exclusion criteria
- Cognitive impairment, Montreal Cognitive Assessment (MoCa) < 20 - Global aphasia that makes understanding study-related information impossible - Other neurological or other conditions causing persistent clinically significant gait or balance disturbances (BASEC)
Trial sites
Luzern, Zurich
(BASEC)
Sponsor
Prof. Dr. med. Christian Baumann Universitätsspital Zürich
(BASEC)
Contact
Contact Person Switzerland
Nora-Hjördis Moser
043 253 95 67
stimuloop@clutterusz.chUniversitätsspital Zürich
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
09.02.2024
(BASEC)
ICTRP Trial ID
NCT06608875 (ICTRP)
Official title (approved by ethics committee)
Precision sensorimotor neurorehabilitation through personalized stimulation loops in a proof-of-principle study (BASEC)
Academic title
Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops in a Proof-of-principle Study (ICTRP)
Public title
Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops (ICTRP)
Disease under investigation
Parkinson Disease (ICTRP)
Intervention under investigation
Behavioral: Hyper-personalized feedback (HPF intervention);Behavioral: Targeted auditory stimulation during sleep (TASS verum intervention);Behavioral: Control targeted auditory stimulation during sleep (TASS sham intervention) (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- 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 Criteria:
- 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) (ICTRP)
not available
Primary and secondary end points
6 min walking test;MiniBEST test (ICTRP)
Phase Coordination Index;Continuous Relative Phase;Variability;Symmetry;Margin of Stability;Resilience (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
ETH Zurich (Switzerland);Cereneo AG;University Children's Hospital, Zurich;Lake Lucerne Institute AG (ICTRP)
Additional contacts
Angelina Maric, Angelina.Maric@usz.ch, +41 44 255 86 15 (ICTRP)
Secondary trial IDs
2023-01400 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06608875 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available