Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Clinical Trial

Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease

NCT: NCT07105280 · NOT_YET_RECRUITING

NCT IDNCT07105280
StatusNOT_YET_RECRUITING
Start Date2026-10-01
Completion2027-10-01
SponsorHagaZiekenhuis (OTHER)
First posted
Last updated

Brief Summary

This 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.

Frequently Asked Questions

What is Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease?

Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease is a clinical trial registered under NCT07105280. Current status: NOT_YET_RECRUITING.

What is the status of NCT07105280?

The current status of NCT07105280 (Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease) is: NOT_YET_RECRUITING.

When did Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease start?

Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease started on 2026-10-01.

Related Devices

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.