CANadian Adaptive DBS TriAl (CANADA)

July 16, 2024 updated by: Alfonso Fasano, University of Toronto

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Movement Disorders Centre - Toronto Western Hospital
        • Contact:
        • Principal Investigator:
          • Alfonso Fasano, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Continuous DBS
Device: Continuous DBS
aDBS vs cDBS
Active Comparator: Adaptive DBS
Device: Adaptive DBS
aDBS vs cDBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) II: Motor Aspects of Experiences of Daily Living (M-EDL), range 0-52. Lower scores reflect better motor experience.
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
Parkinson's Disease Questionnaire (PDQ39): 8 dimensions, 5-point ordinal scoring system, each dimension total score range from 0 to 100. Lower scores reflect better QoL.
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
Gait analysis (off and on medication) using the Zeno Walkway by Protokinetics.
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
Phonetic speech analysis (off and on medication) using the Praat software (Phonetic Sciences, Amsterdam, The Netherlands). Increased phonation reflects better speech quality.
Baseline, 5 months after IPG change, 8 months after battery change

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Motor Outcomes (adaptive DBS vs continuous DBS arms) using Unified Parkinson's Disease Rating Scale part III (motor examination)
Time Frame: Baseline, 2-5 months after IPG change, 8 months after battery change
Unified Parkinson's Disease Rating Scale motor examination (MDS-UPDRS III) score, range 0-132. Lower scores reflect less motor impairment.
Baseline, 2-5 months after IPG change, 8 months after battery change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

May 29, 2022

First Posted (Actual)

June 2, 2022

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 16, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-5527

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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