Investigating Adaptive Deep Brain Stimulation in Parkinson's Disease Management

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease, Idiopathic

• Registration Number: NCT06891781
• Lead Sponsor: Newronika

Brief Summary

The goal of this prospective, multi-center, randomized, double-blind, crossover clinical trial is to evaluate the effectiveness and safety of adaptive DBS (aDBS) and conventional DBS (cDBS) delivered through the AlphaDBS system, in levodopa-responsive Parkinson's disease subjects. Data from previous studies conducted in Europe indicate that the use of the AlphaDBS system is safe and effective in both aDBS and cDBS modes. However, such studies suggest that aDBS may lead to more ON-time without troublesome dyskinesias in some patients. The study is designed to first demonstrate safety of effectiveness of cDBS, then to directly compare effectiveness of aDBS relative to cDBS. Subjects enrolled in the study will undergo multiple visits to assess the improvement of PD symptoms and will be randomized to Mode 1 for three months, followed by Mode 2. At the end of Mode 2, subjects will select their preferred mode, which will be maintained for 3 additional months. Subjects will complete patient diaries at different time points to evaluate their symptoms throughout the day.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-27
• Study Start: 2025-06
• Primary Completion: 2028-02
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Improvement in Good On Time (GOT)	After 3 months of follow up in cDBS as compared with pre-op baseline	Mean improvement in GOT with conventional DBS (cDBS), when compared with pre-operative baseline

Secondary Outcome Measures

Name	Time	Method
PDQ-39 score difference between aDBS and cDBS	After 3 months of follow up in each mode	The mean difference in PDQ-39 score (aDBS - cDBS) at the end of the second crossover period
Subject Preference for aDBS vs. cDBS	After 3 months of follow up in each mode	The proportion of subjects that prefer adaptive mode over conventional mode, according to subject preference selection
Comparison of Subject Preference for aDBS vs. cDBS based on PGI-I Ratings	After 3 months of follow up in cDBS as compared with pre-op baseline	Proportion of subjects rating aDBS higher than cDBS when reporting on the PGI-I
GOT difference between aDBS and cDBS	After 3 months of follow up in each mode	The mean difference in GOT (aDBS - cDBS) at the end of the second crossover period
UPDRS III score difference between aDBS and cDBS	After 3 months of follow up in each mode	The mean difference in UPDRS III scores (aDBS - cDBS) at the end of the second crossover period