CANadian Adaptive DBS TriAl

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Device: Continuous DBS; Device: Adaptive DBS

• Registration Number: NCT05402163
• Lead Sponsor: University of Toronto

Brief Summary

Parkinsonian symptoms, such as freezing of gait (FOG) or hypophonia, play a significant role in reducing quality of life for Parkinson disease (PD) patients, and are poorly responsive or can worsen with deep brain stimulation (DBS). Repeated adjustments of stimulation parameters may be beneficial however, continuous DBS (cDBS) does not adapt to the patients' rapidly fluctuating clinical status and does not take into account reliable and consistent state-trait biomarkers. These biomarkers can be recorded by the electrode itself as local field potentials (LFP). These LFPs can be used to guide stimulation output by means of a 'closed loop' or 'adaptive' DBS (aDBS).

This is a pilot, two-phase, double-blinded, cross-over study of chronic Adaptive vs. Continuous STN DBS in patients with PD by using a novel implantable DBS system that can automatically adjust stimulation parameters based on the patient's clinical condition. The study will test the hypothesis that aDBS stimulation will treat motor fluctuations similarly to continuous stimulation but it will be superior to the latter in the treatment of speech, gait impairment and falls.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-05-29
• Study First Posted: 2022-06-02
• Study Start: 2024-06-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• PD treated with bilateral STN DBS using Medtronic lead
• Able to provide informed consent and comply with study protocol
• Need to replace the implantable pulse generator (IPG) due to battery end of life
• Presence of disabling gait and/or balance and/or speech issues, as clinically judged by the PI and the patient
• Evidence that these disabling gait and/or balance and/or speech issues are worsened by DBS, i.e. they improve after turning DBS off.
• Use of contact 1 and/or 2 on one hemisphere and/or 9 and/or 10 on the other one
• Good LFP signal (assessable only after IPG replacement with Percept) in at least one hemisphere

Exclusion Criteria

• Previous DBS surgery without Medtronic products
• Potential use of any therapeutic stimulation configuration (such as bipolar) during the study which will prevent the use of aDBS
• Presence of any other disorders potentially impacting the outcome measures (e.g. orthopaedic issues)
• Medically unstable
• Severe non-motor problems, such as depression, dementia, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Continuous DBS	Continuous DBS	-
Adaptive DBS	Adaptive DBS	-

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life (QoL) using Parkinson's Disease Questionnaire (PDQ39)	Baseline, 5 months after IPG change, 8 months after battery change	Parkinson's Disease Questionnaire (PDQ39): 8 dimensions, 5-point ordinal scoring system, each dimension total score range from 0 to 100. Lower scores reflect better QoL.
Change in Activities of Daily Living using the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II	Baseline, 5 months after IPG change, 8 months after battery change	Unified Parkinson's Disease Rating Scale (MDS-UPDRS) II: Motor Aspects of Experiences of Daily Living (M-EDL), range 0-52. Lower scores reflect better motor experience.
Change in Speech Quality using the Praat software (Phonetic Sciences)	Baseline, 5 months after IPG change, 8 months after battery change	Phonetic speech analysis (off and on medication) using the Praat software (Phonetic Sciences, Amsterdam, The Netherlands). Increased phonation reflects better speech quality.
Change in Gait using the Zeno Walkway by Protokinetics	Baseline, 5 months after IPG change, 8 months after battery change	Gait analysis (off and on medication) using the Zeno Walkway by Protokinetics.

Secondary Outcome Measures

Name	Time	Method
Change in Motor Outcomes (adaptive DBS vs continuous DBS arms) using Unified Parkinson's Disease Rating Scale part III (motor examination)	Baseline, 2-5 months after IPG change, 8 months after battery change	Unified Parkinson's Disease Rating Scale motor examination (MDS-UPDRS III) score, range 0-132. Lower scores reflect less motor impairment.

Trial Locations

Locations (1)

Movement Disorders Centre - Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada