Active patterned repetitive transc… for Parkinson's (NCT07397377)

Brain stimulation reduces movement slowness

Trial ID
NCT07397377
Official Title
Enhancing rTMS Effects Through a State-Dependent Approach - An Intervention for Bradykinesia in Parkinson's Disease
Goal
Brain stimulation reduces movement slowness
Phase
NA
Status
RECRUITING
Sponsor
Danish Research Centre for Magnetic Resonance
Study Type
INTERVENTIONAL
Enrollment
27 participants
Conditions
Bradykinesia, Parkinson Disease
Interventions
Active patterned repetitive transcranial magnetic stimulation (prTMS), Sham patterned repetitive transcranial magnetic stimulation (prTMS)

Summary For Families

The team aims to see whether patterned magnetic stimulation over a brain area called the supplementary motor area can reduce bradykinesia, the slowed, smaller, and harder-to-start movements that affect daily life in Parkinson's. They use a non-invasive patterned repetitive magnetic technique called quadri-pulse stimulation, which delivers bursts of four quick pulses at 200 hertz and times the bursts to moments just before or between movements to try to boost the brain's responsiveness, comparing active treatment to a sham (placebo) condition. Each participant gets each timing in a crossover design, and movement changes are measured with standard Parkinson's movement rating scales. Adults 18 to 80 with clinically established or probable Parkinson's who have been on stable Parkinson's medicines for at least four weeks can apply; people with seizure risk, certain psychiatric conditions or certain medications, frequent benzodiazepine or opioid use, pregnancy, or who cannot have MRI or magnetic stimulation are not eligible.

Locations

  • DRCMR, Hvidovre, Denmark

Frequently Asked Questions

What is this trial testing?
This trial is studying Active patterned repetitive transcranial magnetic stimulation (prTMS). The team aims to see whether patterned magnetic stimulation over a brain area called the supplementary motor area can reduce bradykinesia, the slowed, smaller, and harder-to-start movements that affect daily life in Parkinson's. They use a non-invasive patterned repetitive magnetic technique called quadri-pulse stimulation, which delivers bursts of four quick pulses at 200 hertz and times the bursts to moments just before or between movements to try to boost the brain's responsiveness, comparing active treatment to a sham (placebo) condition. Each participant gets each timing in a crossover design, and movement changes are measured with standard Parkinson's movement rating scales. Adults 18 to 80 with clinically established or probable Parkinson's who have been on stable Parkinson's medicines for at least four weeks can apply; people with seizure risk, certain psychiatric conditions or certain medications, frequent benzodiazepine or opioid use, pregnancy, or who cannot have MRI or magnetic stimulation are not eligible.
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?
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 4 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 is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. It also includes a placebo or sham phase, so you would be on that during another period. Ask the coordinator for the exact sequence and how long each phase lasts.
What procedures are involved in this trial?
Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.

Related Reading

View on ClinicalTrials.gov