Improve thinking with brain stimulation
- Trial ID
- NCT06090682
- Official Title
- Effect and Mechanism of Deep Brain Stimulation and Transcranial Magnetic Stimulation on Parkinson's Disease With Cognitive Impairment
- Goal
- Improve thinking with brain stimulation
- Status
- RECRUITING
- Sponsor
- Tianjin Huanhu Hospital
- Study Type
- OBSERVATIONAL
- Enrollment
- 200 participants
- Conditions
- Parkinson Disease, Cognitive Impairment
- Interventions
- Deep Brain Stimulation(DBS) and Transcranial Magnetic Stimulation(TMS)
Summary For Families
The goal is to understand whether and how deep brain stimulation and transcranial magnetic stimulation can improve thinking and the brain circuits behind cognitive decline in people with Parkinson's who have had the disease for several years. DBS implants electrodes in the subthalamic nucleus to modulate abnormal circuit activity that drives symptoms and can influence cognition, while TMS uses noninvasive magnetic pulses to boost targeted cortical networks; the study will track cognitive changes and the underlying brain mechanisms, including how these effects relate to levodopa response. They are enrolling up to 200 adults up to age 75 with Parkinson's for more than 5 years who show at least a 30% improvement with an acute levodopa dose and are candidates for STN DBS, excluding those with severe cognitive impairment, major psychiatric illness, atypical parkinsonism, or surgical contraindications.
Locations
- Tianjin Huanhu Hospital, Tianjin, Tianjin Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Deep Brain Stimulation(DBS) and Transcranial Magnetic Stimulation(TMS). The goal is to understand whether and how deep brain stimulation and transcranial magnetic stimulation can improve thinking and the brain circuits behind cognitive decline in people with Parkinson's who have had the disease for several years. DBS implants electrodes in the subthalamic nucleus to modulate abnormal circuit activity that drives symptoms and can influence cognition, while TMS uses noninvasive magnetic pulses to boost targeted cortical networks; the study will track cognitive changes and the underlying brain mechanisms, including how these effects relate to levodopa response. They are enrolling up to 200 adults up to age 75 with Parkinson's for more than 5 years who show at least a 30% improvement with an acute levodopa dose and are candidates for STN DBS, excluding those with severe cognitive impairment, major psychiatric illness, atypical parkinsonism, or surgical contraindications.
- Who can participate?
- Participants must be 75 Years or younger.
- 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 3 years.
- 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.