Improve thinking through implanted stimulation
- Trial ID
- NCT06518824
- Official Title
- Theta Deep Brain Stimulation for Cognitive Enhancement in Parkinson's Disease
- Goal
- Improve thinking through implanted stimulation
- 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
They're testing whether theta-frequency stimulation through existing subthalamic nucleus DBS leads can improve memory and attention problems that some people with Parkinson's experience. The team will briefly switch patients' implanted STN DBS devices between usual settings and theta-frequency pulses to try to boost the brain's natural theta rhythms that support learning and attention, this is an adjustment to the implanted DBS hardware used alongside medications like levodopa, not a replacement for them. Adults 18 to 80 who already have STN DBS implants with pre- and post-op imaging, are at least three months post-op, and can complete cognitive testing are eligible, while those with significant dementia, language barriers to 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. They're testing whether theta-frequency stimulation through existing subthalamic nucleus DBS leads can improve memory and attention problems that some people with Parkinson's experience. The team will briefly switch patients' implanted STN DBS devices between usual settings and theta-frequency pulses to try to boost the brain's natural theta rhythms that support learning and attention, this is an adjustment to the implanted DBS hardware used alongside medications like levodopa, not a replacement for them. Adults 18 to 80 who already have STN DBS implants with pre- and post-op imaging, are at least three months post-op, and can complete cognitive testing are eligible, while those with significant dementia, language barriers to 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?
- 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 9 months.
- 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.