DBS On for Parkinson's (NCT06518824)
Brain stimulation improves working memory
- Trial ID
- NCT06518824
- Official Title
- Theta Deep Brain Stimulation for Cognitive Enhancement in Parkinson's Disease
- Goal
- Brain stimulation improves working memory
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of British Columbia
- Study Type
- INTERVENTIONAL
- Enrollment
- 27 participants
- Conditions
- Parkinson Disease, Cognitive Impairment
- Interventions
- DBS On, DBS Off
Summary For Families
Thinking problems are common in Parkinson's, and small studies suggested that delivering a slow "theta" rhythm to a deep brain area called the subthalamic nucleus can improve working memory; this trial tests whether targeting the part of that area connected to prefrontal thinking regions can boost higher-level thinking skills like working memory and flexible control. The team will use patients' existing deep brain stimulation implants and program theta-pattern stimulation either to the thinking-related circuit or to the movement-related circuit, with neither the participant nor the tester knowing which setting is used. Before each visit they use the person’s pre- and post-operative brain scans to map the electrode and pick stimulation settings that best reach the thinking-related or motor-related circuit. Adults 18 to 80 who already have subthalamic deep brain stimulation, have pre- and post-op imaging, are at least three months after surgery, and can complete the cognitive tests may join; people with dementia, language barriers that prevent testing, or major DBS complications are excluded.
Locations
- Leslie and Gordan Diamond Health Care Centre, Vancouver, British Columbia, Canada
Frequently Asked Questions
- What is this trial testing?
- This trial is studying DBS On. Thinking problems are common in Parkinson's, and small studies suggested that delivering a slow "theta" rhythm to a deep brain area called the subthalamic nucleus can improve working memory; this trial tests whether targeting the part of that area connected to prefrontal thinking regions can boost higher-level thinking skills like working memory and flexible control. The team will use patients' existing deep brain stimulation implants and program theta-pattern stimulation either to the thinking-related circuit or to the movement-related circuit, with neither the participant nor the tester knowing which setting is used. Before each visit they use the person’s pre- and post-operative brain scans to map the electrode and pick stimulation settings that best reach the thinking-related or motor-related circuit. Adults 18 to 80 who already have subthalamic deep brain stimulation, have pre- and post-op imaging, are at least three months after surgery, and can complete the cognitive tests may join; people with dementia, language barriers that prevent testing, or major DBS complications 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?
- 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 9 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.
- 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. It also includes a placebo or sham phase, so you would be on that during another period. 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); Surgical procedure (invasive); MRI scan (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.