HagaZiekenhuis — Biomedical Watch V2

Traitements3programmes

Essais1liés

Publications0liées

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Traitements

3

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Optimized adaptive DBSThis multi-center pilot study compares conventional DBS (cDBS) and adaptive DBS (aDBS) in Parkinson's disease patients using the Medtronic Percept™ system. The aim of the study is to identify which patients benefit most from aDBS, and to explore patient and LFP signal characteristics as well as stimulation parameters as potential predictors of treatment preference and efficacy. The study utilizes a blinded, randomized N-of-1 trial design, where each patient tests the following: * Optimized cDBS settings (O-cDBS); * Optimized aDBS settings (O-aDBS) Each setting is evaluated for a minimum of 2 and maximum of 7 days at home in a randomized order (patient blinded). The main study outcome consists of the patient's final preference among the two DBS programs: O-cDBS, or O-aDBS. Secondary outcomes focus on differences between O-cDBS and O-aDBS regarding the following parameters (among others): * Quality of life (PDQ-39); * Patient satisfaction (5-point Likert Scale); * (Non)-motor fluctuations (MDS-UPDRS-III + MDS-NMS-Q); * Time spent in "ON"/"OFF" motor phases (symptom diary + MDS-UPDRS IV); * Time spent experiencing dyskinesia (symptom diary + MDS-UPDRS IV); * Time spent with the most bothersome symptom (symptom diary + MDSUPDRS IV); * Stimulation parameters; * Local field potentials. The study also incorporates real-world home-based assessments using the Experience Sampling Method (ESM) to capture motor and non-motor symptom fluctuations in daily life and identify differences among the three settings.	Parkinson	Non applicable	Traitement symptomatique	Netherlands	À vérifier
Optimized conventional DBSThis multi-center pilot study compares conventional DBS (cDBS) and adaptive DBS (aDBS) in Parkinson's disease patients using the Medtronic Percept™ system. The aim of the study is to identify which patients benefit most from aDBS, and to explore patient and LFP signal characteristics as well as stimulation parameters as potential predictors of treatment preference and efficacy. The study utilizes a blinded, randomized N-of-1 trial design, where each patient tests the following: * Optimized cDBS settings (O-cDBS); * Optimized aDBS settings (O-aDBS) Each setting is evaluated for a minimum of 2 and maximum of 7 days at home in a randomized order (patient blinded). The main study outcome consists of the patient's final preference among the two DBS programs: O-cDBS, or O-aDBS. Secondary outcomes focus on differences between O-cDBS and O-aDBS regarding the following parameters (among others): * Quality of life (PDQ-39); * Patient satisfaction (5-point Likert Scale); * (Non)-motor fluctuations (MDS-UPDRS-III + MDS-NMS-Q); * Time spent in "ON"/"OFF" motor phases (symptom diary + MDS-UPDRS IV); * Time spent experiencing dyskinesia (symptom diary + MDS-UPDRS IV); * Time spent with the most bothersome symptom (symptom diary + MDSUPDRS IV); * Stimulation parameters; * Local field potentials. The study also incorporates real-world home-based assessments using the Experience Sampling Method (ESM) to capture motor and non-motor symptom fluctuations in daily life and identify differences among the three settings.	Parkinson	Non applicable	Traitement symptomatique	Netherlands	À vérifier
Optimized conventional DBSThis multi-center pilot study compares conventional DBS (cDBS) and adaptive DBS (aDBS) in Parkinson's disease patients using the Medtronic Percept™ system. The aim of the study is to identify which patients benefit most from aDBS, and to explore patient and LFP signal characteristics as well as stimulation parameters as potential predictors of treatment preference and efficacy. The study utilizes a blinded, randomized N-of-1 trial design, where each patient tests the following: * Optimized cDBS settings (O-cDBS); * Optimized aDBS settings (O-aDBS) Each setting is evaluated for a minimum of 2 and maximum of 7 days at home in a randomized order (patient blinded). The main study outcome consists of the patient's final preference among the two DBS programs: O-cDBS, or O-aDBS. Secondary outcomes focus on differences between O-cDBS and O-aDBS regarding the following parameters (among others): * Quality of life (PDQ-39); * Patient satisfaction (5-point Likert Scale); * (Non)-motor fluctuations (MDS-UPDRS-III + MDS-NMS-Q); * Time spent in "ON"/"OFF" motor phases (symptom diary + MDS-UPDRS IV); * Time spent experiencing dyskinesia (symptom diary + MDS-UPDRS IV); * Time spent with the most bothersome symptom (symptom diary + MDSUPDRS IV); * Stimulation parameters; * Local field potentials. The study also incorporates real-world home-based assessments using the Experience Sampling Method (ESM) to capture motor and non-motor symptom fluctuations in daily life and identify differences among the three settings.	Parkinson	Non applicable	Traitement symptomatique	Netherlands	À vérifier

Essais cliniques

1

Molécule	Indication / population	Phase	NCT	Titre	Statut
Optimized conventional DBS	Parkinson	Non applicable	NCT07105280	CTRL-PD — Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease	NOT_YET_RECRUITING

Publications

0

Molécule	Indication / population	Titre	Journal	Date
Aucune publication.