Reduce freezing episodes while walking
- Trial ID
- NCT07488026
- Official Title
- Effects of the Stimulation Site of Trans-spinal Magnetic Stimulation Combined With Transcranial Magnetic Stimulation on Functional Mobility in Individuals With Parkinson's Disease
- Goal
- Reduce freezing episodes while walking
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Universidade Federal de Pernambuco
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson's Disease (PD), Gait Disorders, Transcranial Magnetic Stimulation, Spinal Cord Stimulation
- Interventions
- Repetitive Transcranial Magnetic Stimulation, Cervical Trans-spinal Magnetic Stimulation, Thoracic Trans-spinal Magnetic Stimulation
Summary For Families
Researchers want to see if pairing brain magnetic stimulation with magnetic pulses over the spinal cord can improve walking and reduce freezing episodes in people with mid-stage Parkinson's. The approach uses repetitive transcranial magnetic stimulation to modulate motor areas of the brain plus repetitive trans-spinal magnetic stimulation at either the cervical or thoracic level to directly activate spinal motor circuits, with the goal of improving timing and strength of leg muscle activity. Participants stay on their usual dopaminergic medications, so the stimulation is being tested as an add-on to, not a replacement for, levodopa or other Parkinson's drugs. The study enrolls adults 40 and older with neurologist-confirmed PD, Hoehn and Yahr stage 2.5,3, stable dopaminergic treatment for at least three months, at least one freezing-of-gait episode per week, and adequate cognition (MoCA ≥ 21); people with prior PD surgery, metal in the neck or spine, a history of seizures, or other conditions that affect walking are excluded.
Locations
- Universidade Federal de Pernambuco, Recife, Pernambuco, Brazil
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Repetitive Transcranial Magnetic Stimulation. Researchers want to see if pairing brain magnetic stimulation with magnetic pulses over the spinal cord can improve walking and reduce freezing episodes in people with mid-stage Parkinson's. The approach uses repetitive transcranial magnetic stimulation to modulate motor areas of the brain plus repetitive trans-spinal magnetic stimulation at either the cervical or thoracic level to directly activate spinal motor circuits, with the goal of improving timing and strength of leg muscle activity. Participants stay on their usual dopaminergic medications, so the stimulation is being tested as an add-on to, not a replacement for, levodopa or other Parkinson's drugs. The study enrolls adults 40 and older with neurologist-confirmed PD, Hoehn and Yahr stage 2.5,3, stable dopaminergic treatment for at least three months, at least one freezing-of-gait episode per week, and adequate cognition (MoCA ≥ 21); people with prior PD surgery, metal in the neck or spine, a history of seizures, or other conditions that affect walking are excluded.
- Who can participate?
- Participants must be at least 40 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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 trial is estimated to last approximately 10 months.
- 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.