StimuLOOP.PD – Sensory-Motor Precision Neuro-Rehabilitation through Personalized Stimulation Loops for Patients with Parkinson's
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'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)
Critères d'exclusion
- 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)
Lieu de l’étude
Luzern, Zurich
(BASEC)
Sponsor
Prof. Dr. med. Christian Baumann Universitätsspital Zürich
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Nora-Hjördis Moser
043 253 95 67
stimuloop@clutterusz.chUniversitätsspital Zürich
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
09.02.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT06608875 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Precision sensorimotor neurorehabilitation through personalized stimulation loops in a proof-of-principle study (BASEC)
Titre académique
Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops in a Proof-of-principle Study (ICTRP)
Titre public
Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops (ICTRP)
Maladie en cours d'investigation
Parkinson Disease (ICTRP)
Intervention étudiée
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 d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
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)
non disponible
Critères d'évaluation principaux et secondaires
6 min walking test;MiniBEST test (ICTRP)
Phase Coordination Index;Continuous Relative Phase;Variability;Symmetry;Margin of Stability;Resilience (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
ETH Zurich (Switzerland);Cereneo AG;University Children's Hospital, Zurich;Lake Lucerne Institute AG (ICTRP)
Contacts supplémentaires
Angelina Maric, Angelina.Maric@usz.ch, +41 44 255 86 15 (ICTRP)
ID secondaires
2023-01400 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06608875 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible