Transcranial Direct Current Stimul… for Parkinson's (NCT07381907)
Improve walking speed and balance
- Trial ID
- NCT07381907
- Official Title
- Effects of Transcranial Direct Current Stimulation Over the Supplementary Motor Area Combined With Nordic Walking on Gait and Balance in Parkinson's Disease
- Goal
- Improve walking speed and balance
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Universidade Metodista de Piracicaba
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson Disease (PD), Gait Disorders, Postural Balance
- Interventions
- Transcranial Direct Current Stimulation (tDCS), active, Sham transcranial Direct Current Stimulation, Standardized Nordic Walking program
Summary For Families
The goal is to help people with Parkinson's who have slowed walking and balance problems walk more smoothly and reduce gait difficulties. The approach pairs mild, noninvasive transcranial direct current stimulation over the supplementary motor area, which gently increases that brain region's excitability to support gait initiation and motor network plasticity, with a supervised Nordic walking program that uses poles to improve posture and walking rhythm; the stimulation is added to usual Parkinson's medications, not a replacement for levodopa. They are looking for adults 50 to 75 years old with idiopathic Parkinson's at Hoehn and Yahr stage II to IV, a slowed gait (about 6 seconds or more on a 10 meter walk), ability to walk 10 meters with or without a cane or poles, stable PD meds for at least 4 weeks, and cognitive ability to consent (roughly MMSE ≥24). People with implanted cranial devices like DBS or metal in the skull, recent seizures or uncontrolled medical issues, severe fall risk or musculoskeletal/vestibular problems that prevent walking with poles, recent PD medication changes, or current participation in other interventional gait or brain stimulation trials are excluded.
Locations
- UEAFTO - Unidade de Fisioterapia e Terapia Ocupacional, Belém, Pará, Brazil
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Transcranial Direct Current Stimulation (tDCS), active. The goal is to help people with Parkinson's who have slowed walking and balance problems walk more smoothly and reduce gait difficulties. The approach pairs mild, noninvasive transcranial direct current stimulation over the supplementary motor area, which gently increases that brain region's excitability to support gait initiation and motor network plasticity, with a supervised Nordic walking program that uses poles to improve posture and walking rhythm; the stimulation is added to usual Parkinson's medications, not a replacement for levodopa. They are looking for adults 50 to 75 years old with idiopathic Parkinson's at Hoehn and Yahr stage II to IV, a slowed gait (about 6 seconds or more on a 10 meter walk), ability to walk 10 meters with or without a cane or poles, stable PD meds for at least 4 weeks, and cognitive ability to consent (roughly MMSE ≥24). People with implanted cranial devices like DBS or metal in the skull, recent seizures or uncontrolled medical issues, severe fall risk or musculoskeletal/vestibular problems that prevent walking with poles, recent PD medication changes, or current participation in other interventional gait or brain stimulation trials are excluded.
- Who can participate?
- Participants must be between 50 Years and 75 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 8 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 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 attend 12 supervised sessions (3 times per week for 4 weeks).
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.