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CANadian Adaptive DBS TriAl

Parkinson Disease

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.

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    18 to 80

Critères de participation

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.

Lieu de l'étude

Movement Disorders Centre - Toronto Western Hospital
Movement Disorders Centre - Toronto Western Hospital
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Backup Contact

Alexandra Boogers, MBBCh

[email protected]
(416) 603-5800
Primary Contact

Alfonso Fasano, MD, PhD

[email protected]
(416) 603-5800
Étude parrainée par
University of Toronto
Participants recherchés
Plus d'informations
ID de l'étude: NCT05402163