MagVenture MagProX100 stimulator for Parkinson's (NCT03836950)
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?
- 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 Phase 1/Phase 2 trial is estimated to last approximately 7 years.
- 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 trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- Participants will complete assessments at baseline, at endpoint, and at a one month follow-up.