CANadian Adaptive DBS TriAl

Parkinson Disease Clinical Trial

— CANADA  

Official title:

Adaptive/Closed Loop vs. Continuous/Open Loop Deep Brain Stimulation of Subthalamic Nucleus: a Two-Phase, Cross-Over, Double-Blind Trial in Patients With Parkinson's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05402163
• Other study ID #: 17-5527
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Adaptive DBS
aDBS vs cDBS
• Continuous DBS
aDBS vs cDBS

Locations

Country	Name	City	State
Canada	Movement Disorders Centre - Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Activities of Daily Living using the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II	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.	Baseline, 5 months after IPG change, 8 months after battery change
Primary	Change in Quality of Life (QoL) using Parkinson's Disease Questionnaire (PDQ39)	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.	Baseline, 5 months after IPG change, 8 months after battery change
Primary	Change in Gait using the Zeno Walkway by Protokinetics	Gait analysis (off and on medication) using the Zeno Walkway by Protokinetics.	Baseline, 5 months after IPG change, 8 months after battery change
Primary	Change in Speech Quality using the Praat software (Phonetic Sciences)	Phonetic speech analysis (off and on medication) using the Praat software (Phonetic Sciences, Amsterdam, The Netherlands). Increased phonation reflects better speech quality.	Baseline, 5 months after IPG change, 8 months after battery change
Secondary	Change in Motor Outcomes (adaptive DBS vs continuous DBS arms) using Unified Parkinson's Disease Rating Scale part III (motor examination)	Unified Parkinson's Disease Rating Scale motor examination (MDS-UPDRS III) score, range 0-132. Lower scores reflect less motor impairment.	Baseline, 2-5 months after IPG change, 8 months after battery change