StimuLOOP.PD – Sensory-Motor Precision Neuro-Rehabilitation through Personalized Stimulation Loops for Patients with Parkinson's
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Luzern, Zürich
(BASEC)
Sponsor
Prof. Dr. med. Christian Baumann Universitätsspital Zürich
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Nora-Hjördis Moser
043 253 95 67
stimuloop@clutterusz.chUniversitätsspital Zürich
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
09.02.2024
(BASEC)
ICTRP Studien-ID
NCT06608875 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Precision sensorimotor neurorehabilitation through personalized stimulation loops in a proof-of-principle study (BASEC)
Wissenschaftlicher Titel
Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops in a Proof-of-principle Study (ICTRP)
Öffentlicher Titel
Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops (ICTRP)
Untersuchte Krankheit(en)
Parkinson Disease (ICTRP)
Untersuchte Intervention
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)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
6 min walking test;MiniBEST test (ICTRP)
Phase Coordination Index;Continuous Relative Phase;Variability;Symmetry;Margin of Stability;Resilience (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
ETH Zurich (Switzerland);Cereneo AG;University Children's Hospital, Zurich;Lake Lucerne Institute AG (ICTRP)
Weitere Kontakte
Angelina Maric, Angelina.Maric@usz.ch, +41 44 255 86 15 (ICTRP)
Sekundäre IDs
2023-01400 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06608875 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar