Improve gait balance and speech
- Trial ID
- NCT05402163
- Official 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
- Goal
- Improve gait balance and speech
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Toronto
- Study Type
- INTERVENTIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson Disease
- Interventions
- Adaptive DBS, Continuous DBS
Plain-Language Summary
Goal: find out whether adaptive, closed-loop stimulation of the subthalamic nucleus can reduce disabling gait, balance, or speech problems that sometimes get worse with standard continuous DBS. Approach: the team will replace the IPG with a Medtronic device that reads local field potentials and automatically adjusts stimulation in real time, delivering pulses only when brain signals indicate they are needed, and compare that to steady, continuous stimulation in a blinded, cross-over design. Eligibility: enrolling 10 adults age 18 to 80 who already have bilateral STN Medtronic leads and need an IPG replacement, who have gait, balance, or speech issues that improve when DBS is turned off and who have usable LFP signals on at least one side; people with non-Medtronic systems, major medical or psychiatric problems, or other conditions that could affect outcomes are excluded.
Locations
- Movement Disorders Centre - Toronto Western Hospital, Toronto, Ontario, Canada
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Adaptive DBS. Goal: find out whether adaptive, closed-loop stimulation of the subthalamic nucleus can reduce disabling gait, balance, or speech problems that sometimes get worse with standard continuous DBS. Approach: the team will replace the IPG with a Medtronic device that reads local field potentials and automatically adjusts stimulation in real time, delivering pulses only when brain signals indicate they are needed, and compare that to steady, continuous stimulation in a blinded, cross-over design. Eligibility: enrolling 10 adults age 18 to 80 who already have bilateral STN Medtronic leads and need an IPG replacement, who have gait, balance, or speech issues that improve when DBS is turned off and who have usable LFP signals on at least one side; people with non-Medtronic systems, major medical or psychiatric problems, or other conditions that could affect outcomes are excluded.
- Who can participate?
- Participants must be between 18 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year.