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NCT Number: NCT05402163

CANadian Adaptive DBS TriAl

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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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Movement Disorders Centre - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location status: Recruiting

Location contact

Alexandra Boogers, MBBCh

CONTACT

[email protected]

(416) 603-5800 ext. 3158

Alfonso Fasano, MD, PhD

CONTACT

[email protected]

(416) 603-5800 ext. 5961

Alfonso Fasano, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for 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.

Treatment and study plan

Adaptive DBS

Device

aDBS vs cDBS

Continuous DBS

Device

aDBS vs cDBS

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

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

Acronym: CANADA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2022
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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