Improve walking balance and thinking
- Trial ID
- NCT06868160
- Official Title
- Neurotech PD Gait: Multisite Non-invasive Electrical Stimulation to Optimize Motor-cognitive Rehabilitation Response in Parkinson's Disease Subjects With Postural Instability and Gait Disorders
- Goal
- Improve walking balance and thinking
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- IRCCS San Raffaele
- Study Type
- INTERVENTIONAL
- Enrollment
- 71 participants
- Conditions
- Parkinson Disease
- Interventions
- Rehabilitation, SHAM tDCS, tDCS, tsDCS (first cycle), tsDCS (second cycle), SHAM tsDCS (first cycle), SHAM tsDCS (second cycle), SHAM tsDCS
Summary For Families
The goal is to help people with Parkinson's who have postural instability and gait problems improve walking, balance, and the motor-cognitive benefits they get from rehabilitation. The approach pairs painless, low-intensity direct currents to the scalp (tDCS) and over the spinal cord (tsDCS) with rehab exercises, aiming to boost brain and spinal circuit excitability so motor learning and sensorimotor control stick better; sessions include sham controls and the intervention is tested as an add-on while participants remain on stable dopaminergic medication. They are looking for adults 45 to 85 with idiopathic PD of the PIGD type, Hoehn and Yahr stage up to 4, no dementia (MMSE ≥24), stable dopaminergic therapy for at least 4 weeks, and no MRI contraindications or implanted neurostimulation devices.
Locations
- San Raffaele Neurotech Hub, Milan, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Rehabilitation. The goal is to help people with Parkinson's who have postural instability and gait problems improve walking, balance, and the motor-cognitive benefits they get from rehabilitation. The approach pairs painless, low-intensity direct currents to the scalp (tDCS) and over the spinal cord (tsDCS) with rehab exercises, aiming to boost brain and spinal circuit excitability so motor learning and sensorimotor control stick better; sessions include sham controls and the intervention is tested as an add-on while participants remain on stable dopaminergic medication. They are looking for adults 45 to 85 with idiopathic PD of the PIGD type, Hoehn and Yahr stage up to 4, no dementia (MMSE ≥24), stable dopaminergic therapy for at least 4 weeks, and no MRI contraindications or implanted neurostimulation devices.
- Who can participate?
- Participants must be between 45 Years and 85 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 3 years.
- 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.