Improve cognitive function in Parkinsons
- Trial ID
- NCT03836950
- Official Title
- rTMS as a Cognitive Rehabilitation Approach in Veterans With Parkinson's Disease
- Goal
- Improve cognitive function in Parkinsons
- Phase
- PHASE1, PHASE2
- Status
- RECRUITING
- Sponsor
- VA Office of Research and Development
- Study Type
- INTERVENTIONAL
- Enrollment
- 56 participants
- Conditions
- Parkinson's Disease, Mild Cognitive Impairment
- Interventions
- MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark), MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)
Summary For Families
The goal is to help veterans with Parkinson's who have mild cognitive impairment improve thinking and memory, especially attention and executive skills that affect daily life. The approach uses a MagVenture rTMS machine to deliver repeated magnetic pulses to targeted brain regions, boosting neuronal activity and strengthening networks involved in memory and attention; it is a non-drug, external therapy that does not directly change levodopa but requires participants to stay on stable Parkinson's medications. Eligible participants are veterans 50 or older seen at Hines or Jesse Brown VA with neurologist-confirmed Parkinson's or atypical parkinsonism and mild cognitive impairment, while people with dementia, prior deep brain stimulation, implanted pacemakers or metal in the head, a seizure history, severe tremor, or other conditions that raise seizure risk are excluded.
Locations
- Jesse Brown VA Medical Center, Chicago, IL, Chicago, Illinois, United States
- Edward Hines Jr. VA Hospital, Hines, IL, Hines, Illinois, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark). The goal is to help veterans with Parkinson's who have mild cognitive impairment improve thinking and memory, especially attention and executive skills that affect daily life. The approach uses a MagVenture rTMS machine to deliver repeated magnetic pulses to targeted brain regions, boosting neuronal activity and strengthening networks involved in memory and attention; it is a non-drug, external therapy that does not directly change levodopa but requires participants to stay on stable Parkinson's medications. Eligible participants are veterans 50 or older seen at Hines or Jesse Brown VA with neurologist-confirmed Parkinson's or atypical parkinsonism and mild cognitive impairment, while people with dementia, prior deep brain stimulation, implanted pacemakers or metal in the head, a seizure history, severe tremor, or other conditions that raise seizure risk are excluded.
- Who can participate?
- Participants must be at least 50 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 Phase 1/Phase 2 trial is estimated to last approximately 7 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.