RecruitingNot ApplicableNCT05402163

CANadian Adaptive DBS TriAl

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


Sponsor

University of Toronto

Enrollment

10 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an adaptive deep brain stimulation (DBS) system for people with Parkinson's disease — where the device automatically adjusts its stimulation in real time based on brain signals, rather than delivering a constant fixed pulse. **You may be eligible if...** - You have Parkinson's disease and already have bilateral DBS implants using a Medtronic device - Your current DBS battery needs replacement (end of life) - You have significant ongoing problems with gait, balance, or speech that your current DBS settings are not fully controlling - You are able to provide informed consent **You may NOT be eligible if...** - You use a DBS device from a different manufacturer - You have dementia or significant cognitive impairment - Your gait/balance problems are due to causes other than Parkinson's - You have an active serious infection near the device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEAdaptive DBS

aDBS vs cDBS

DEVICEContinuous DBS

aDBS vs cDBS


Locations(1)

Movement Disorders Centre - Toronto Western Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05402163


Related Trials