DBS for Parkinson's (NCT05934747)
Change stimulation to improve balance
- Trial ID
- NCT05934747
- Official Title
- Aim 3 Particle Swarm Optimization Postural Instability Gait Disorder
- Goal
- Change stimulation to improve balance
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Minnesota
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson's Disease and Parkinsonism
- Interventions
- DBS
Summary For Families
Researchers are testing whether changing deep brain stimulation settings to favor one of two brain pathways between the globus pallidus and the pedunculopontine nucleus can improve balance and walking problems in Parkinson's. Participants who already have standard deep brain stimulation will try two different settings that are designed to differ in how much they activate the pathway from globus pallidus to pedunculopontine nucleus versus the pathway from pedunculopontine nucleus to globus pallidus, with each setting used for about two weeks between lab visits so daily activity and quality of life can be measured and slower effects can appear. Researchers hypothesize that activating the pathway from the pedunculopontine nucleus to the globus pallidus will best help balance and walking, and the findings will help design future trials. Adults 18 to 85 are eligible if they have bilateral deep brain stimulation leads in the subthalamic nucleus or globus pallidus placed at least three months earlier, have had a preoperative 7-Tesla MRI and a post-op CT, can walk during off-medication and off-stimulation testing, and pass a brief cognitive screen or capacity assessment.
Locations
- University of Minnesota, Minneapolis, Minnesota, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying DBS. Researchers are testing whether changing deep brain stimulation settings to favor one of two brain pathways between the globus pallidus and the pedunculopontine nucleus can improve balance and walking problems in Parkinson's. Participants who already have standard deep brain stimulation will try two different settings that are designed to differ in how much they activate the pathway from globus pallidus to pedunculopontine nucleus versus the pathway from pedunculopontine nucleus to globus pallidus, with each setting used for about two weeks between lab visits so daily activity and quality of life can be measured and slower effects can appear. Researchers hypothesize that activating the pathway from the pedunculopontine nucleus to the globus pallidus will best help balance and walking, and the findings will help design future trials. Adults 18 to 85 are eligible if they have bilateral deep brain stimulation leads in the subthalamic nucleus or globus pallidus placed at least three months earlier, have had a preoperative 7-Tesla MRI and a post-op CT, can walk during off-medication and off-stimulation testing, and pass a brief cognitive screen or capacity assessment.
- Who can participate?
- Participants must be between 18 Years and 85 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 4 years and 2 months.
- 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.
- 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.