Adaptive DBS for Parkinson's (NCT05402163)
Test adaptive stimulation for walking
- 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
- Test adaptive stimulation for walking
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Toronto
- Study Type
- INTERVENTIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson Disease
- Interventions
- Adaptive DBS, Continuous DBS
Summary For Families
The goal is to test whether an adaptive, or closed-loop, deep brain stimulation system can control the usual movement ups and downs as well as regular continuous stimulation while doing a better job with speech problems, walking freezes, and falls that often reduce quality of life. The approach uses a new implantable stimulator that reads brain signals from the implanted electrode and automatically adjusts stimulation in real time, and each person will try both the adaptive and the continuous settings in a double-blind, crossover format. The trial is looking for adults 18 to 80 who already have bilateral deep brain stimulation with Medtronic leads, need to replace their implantable pulse generator because the battery is low, can give informed consent, and have disabling speech or balance or walking problems that worsen with their current stimulation.
Locations
- Movement Disorders Centre - Toronto Western Hospital, Toronto, Ontario, Canada
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Adaptive DBS. The goal is to test whether an adaptive, or closed-loop, deep brain stimulation system can control the usual movement ups and downs as well as regular continuous stimulation while doing a better job with speech problems, walking freezes, and falls that often reduce quality of life. The approach uses a new implantable stimulator that reads brain signals from the implanted electrode and automatically adjusts stimulation in real time, and each person will try both the adaptive and the continuous settings in a double-blind, crossover format. The trial is looking for adults 18 to 80 who already have bilateral deep brain stimulation with Medtronic leads, need to replace their implantable pulse generator because the battery is low, can give informed consent, and have disabling speech or balance or walking problems that worsen with their current stimulation.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. Ask the coordinator for the exact sequence and how long each phase lasts.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.