Status:
RECRUITING
CANadian Adaptive DBS TriAl
Lead Sponsor:
University of Toronto
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05402163
Start Date
June 1 2024
End Date
December 1 2025
Last Update
July 18 2024
Active Locations (1)
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1
Movement Disorders Centre - Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8