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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Movement Disorders Centre - Toronto Western Hospital
RECRUITING
Toronto
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 10
Treatments
Other: Continuous DBS
Active_comparator: Adaptive DBS
Sponsors
Leads: University of Toronto

This content was sourced from clinicaltrials.gov