Transcranial pulsed electromagneti… for Parkinson's (NCT07306104)
Magnetic pulses reduce movement stiffness
- Trial ID
- NCT07306104
- Official Title
- The Effect of Long-term Treatment of Parkinson's Disease With T-PEMF
- Goal
- Magnetic pulses reduce movement stiffness
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Southern Denmark
- Study Type
- INTERVENTIONAL
- Enrollment
- 90 participants
- Conditions
- PARKINSON DISEASE (Disorder)
- Interventions
- Transcranial pulsed electromagnetic fields (T-PEMF), Sham (No Treatment)
Summary For Families
Testing whether long-term sessions of transcranial pulsed electromagnetic fields can ease motor symptoms and support brain function in people with mild Parkinson's. The treatment uses noninvasive electromagnetic pulses over the scalp to gently modulate brain activity and promote neuroplasticity, and it is compared with a sham procedure while participants stay on their usual, stable Parkinson medications rather than replacing levodopa. Adults 18 and up with idiopathic Parkinson's at Hoehn and Yahr stage 1 or 2 who can follow procedures and have an MMSE score over 22 may qualify; people with brain implants, epilepsy, recent medication changes, certain anticoagulant use, prior stroke, pregnancy, or other neurological disorders are excluded.
Locations
- Odense University Hospital, Odense, Denmark
- University of Southern Denmark, Odense, Denmark
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Transcranial pulsed electromagnetic fields (T-PEMF). Testing whether long-term sessions of transcranial pulsed electromagnetic fields can ease motor symptoms and support brain function in people with mild Parkinson's. The treatment uses noninvasive electromagnetic pulses over the scalp to gently modulate brain activity and promote neuroplasticity, and it is compared with a sham procedure while participants stay on their usual, stable Parkinson medications rather than replacing levodopa. Adults 18 and up with idiopathic Parkinson's at Hoehn and Yahr stage 1 or 2 who can follow procedures and have an MMSE score over 22 may qualify; people with brain implants, epilepsy, recent medication changes, certain anticoagulant use, prior stroke, pregnancy, or other neurological disorders are excluded.
- Who can participate?
- Participants must be at least 18 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 trial is estimated to last approximately 1 year and 10 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 trial has 4 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 4 chance (roughly 25%) 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?
- Visits occur before treatment initiation, after 6 months of treatment, and after 12 months of treatment (over 12 months).