CANadian Adaptive DBS TriAl

NCT05402163 | Recruiting

• 1 other identifier: 17-5527
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Change in Activities of Daily Living using the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II

  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)

  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

  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)

  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 Outcomes (1)

• Change in Motor Outcomes (adaptive DBS vs continuous DBS arms) using Unified Parkinson's Disease Rating Scale part III (motor examination)

  Baseline, 2-5 months after IPG change, 8 months after battery change

Study Arms (2)

Continuous DBS

OTHER

Device: Continuous DBS

Adaptive DBS

ACTIVE COMPARATOR

Device: Adaptive DBS

Interventions

Adaptive DBS DEVICE

aDBS vs cDBS

Adaptive DBS

Continuous DBS DEVICE

aDBS vs cDBS

Continuous DBS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Movement Disorders Centre - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - University of Toronto

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: June 2, 2022
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)