Recruiting

DBS

Sponsor:

University of Toronto

Code:

NCT05402163

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Adaptive DBS

Continuous DBS

Study Details

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.

Conditions

Parkinson Disease

Study ID

NCT05402163

Start date

Jun 1, 2024

Status verified date

Jul, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Continuous DBS

active comparator: Adaptive DBS

Interventions

Adaptive DBS

aDBS vs cDBS

Continuous DBS

aDBS vs cDBS

Primary outcome measure

  • Change in Activities of Daily Living using the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II [ Time Frame: Baseline, 5 months after IPG change, 8 months after battery change ]
  • Change in Quality of Life (QoL) using Parkinson's Disease Questionnaire (PDQ39) [ Time Frame: Baseline, 5 months after IPG change, 8 months after battery change ]
  • Change in Gait using the Zeno Walkway by Protokinetics [ Time Frame: Baseline, 5 months after IPG change, 8 months after battery change ]
  • Change in Speech Quality using the Praat software (Phonetic Sciences) [ Time Frame: Baseline, 5 months after IPG change, 8 months after battery change ]

Central Contacts and Locations

Locations

Movement Disorders Centre - Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Alfonso Fasano, MD, PhD

(416) 603-5800alfonso.fasano@uhn.ca

Alexandra Boogers, MBBCh

(416) 603-5800alexandra.boogers@uhn.ca

Principal Investigator:

Alfonso Fasano, MD, PhD

More Information

Sponsor

University of Toronto

Last update posted

Jul 18, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2024-07-18.