active TMS for Parkinson's (NCT06570824)
Delay and reduce involuntary movements
- Trial ID
- NCT06570824
- Official Title
- Network Based Repetitive Transcranial Magnetic Stimulation (rTMS) as an Intervention for Levodopa-induced Dyskinesia (LID) in Parkinson's Disease (PD)
- Goal
- Delay and reduce involuntary movements
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Danish Research Centre for Magnetic Resonance
- Study Type
- INTERVENTIONAL
- Enrollment
- 68 participants
- Conditions
- Dyskinesia, Drug-Induced, Parkinson Disease
- Interventions
- active TMS, sham TMS
Summary For Families
The goal is to reduce levodopa-induced dyskinesia, the involuntary movements that can come at the peak effect of levodopa, by delaying when they start after a dose and by making them less severe. The approach uses repetitive transcranial magnetic stimulation applied to the pre-supplementary motor area of the brain, comparing real versus sham stimulation while testing short bursts of pulses at two different burst rates drawn from gamma and beta frequency ranges, and tailoring intensity and placement to each person’s brain anatomy. Adults 18 to 80 with Parkinson’s who have peak-of-dose levodopa-induced dyskinesia and stable Parkinson medicines for at least four weeks are eligible, while people with epilepsy risk, certain psychiatric or other neurological conditions, some medications, or pregnancy (or no contraception in women of childbearing age) are excluded.
Locations
- DRCMR, Hvidovre, Denmark
Frequently Asked Questions
- What is this trial testing?
- This trial is studying active TMS. The goal is to reduce levodopa-induced dyskinesia, the involuntary movements that can come at the peak effect of levodopa, by delaying when they start after a dose and by making them less severe. The approach uses repetitive transcranial magnetic stimulation applied to the pre-supplementary motor area of the brain, comparing real versus sham stimulation while testing short bursts of pulses at two different burst rates drawn from gamma and beta frequency ranges, and tailoring intensity and placement to each person’s brain anatomy. Adults 18 to 80 with Parkinson’s who have peak-of-dose levodopa-induced dyskinesia and stable Parkinson medicines for at least four weeks are eligible, while people with epilepsy risk, certain psychiatric or other neurological conditions, some medications, or pregnancy (or no contraception in women of childbearing age) are excluded.
- 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 2 years and 9 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.