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New treatment option for Parkinson Disease
Official title CANadian Adaptive DBS TriAl
ClinicalTrials.gov ID: NCT05402163
What this study is testing
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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.
You likely can't join 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.