Clinical trial NCT05402163: CANadian Adaptive DBS TriAl
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Activities of Daily Living using the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II
timeFrame: Baseline, 5 months after IPG change, 8 months after battery change
measure: Change in Quality of Life (QoL) using Parkinson's Disease Questionnaire (PDQ39)
timeFrame: Baseline, 5 months after IPG change, 8 months after battery change
measure: Change in Gait using the Zeno Walkway by Protokinetics
timeFrame: Baseline, 5 months after IPG change, 8 months after battery change
measure: Change in Speech Quality using the Praat software (Phonetic Sciences)
timeFrame: Baseline, 5 months after IPG change, 8 months after battery change
Secondary outcomes:
measure: Change in Motor Outcomes (adaptive DBS vs continuous DBS arms) using Unified Parkinson's Disease Rating Scale part III (motor examination)
timeFrame: Baseline, 2-5 months after IPG change, 8 months after battery change
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Movement Disorders Centre - Toronto Western Hospital
state: Ontario
Study officials:
References: