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?
- 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 8 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.