CANadian Adaptive DBS TriAl (CANADA)

University of Toronto

Status

Enrolling

Conditions

Parkinson Disease

Treatments

Device: Continuous DBS

Device: Adaptive DBS

Study type

Interventional

Funder types

Other

Identifiers

NCT05402163

17-5527

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.