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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.