Rehabilitation for Parkinson's (NCT06868160)
Improve walking using electrical stimulation
- 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 using electrical stimulation
- 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 trouble with balance and walking, to see if adding non-invasive electrical stimulation can boost the benefits of rehab. The approach pairs two cycles of motor-cognitive rehab that involve watching movements, imagining them, then practicing them, with either fake stimulation that quickly fades or real stimulation using small direct currents applied to the head (transcranial direct current stimulation) or the spine (trans-spinal direct current stimulation); the design compares stimulation to sham and tests head alone versus head plus spine stimulation in a crossover. Participants have detailed tests of walking, brain activity (magnetic resonance imaging, near-infrared brain monitoring, and electroencephalography), and blood samples before and after training and at follow-ups to see if effects last. People 45 to 85 years old with the postural instability and gait disorder form of Parkinson's, on stable Parkinson's medications and without dementia or implanted stimulators or MRI problems can join, plus age- and sex-matched healthy controls for baseline comparisons.
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 trouble with balance and walking, to see if adding non-invasive electrical stimulation can boost the benefits of rehab. The approach pairs two cycles of motor-cognitive rehab that involve watching movements, imagining them, then practicing them, with either fake stimulation that quickly fades or real stimulation using small direct currents applied to the head (transcranial direct current stimulation) or the spine (trans-spinal direct current stimulation); the design compares stimulation to sham and tests head alone versus head plus spine stimulation in a crossover. Participants have detailed tests of walking, brain activity (magnetic resonance imaging, near-infrared brain monitoring, and electroencephalography), and blood samples before and after training and at follow-ups to see if effects last. People 45 to 85 years old with the postural instability and gait disorder form of Parkinson's, on stable Parkinson's medications and without dementia or implanted stimulators or MRI problems can join, plus age- and sex-matched healthy controls for baseline comparisons.
- 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?
- 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 3 years.
- 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 a group that receives no study treatment (you would continue your usual care) alongside the treatment groups. Because assignment is random, you have about a 1 in 4 chance (roughly 25%) of being in the no-treatment group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- Patients are re-evaluated at the 6-week (W6) and 20-week (W20) visits, and measures are repeated at the 14-week (W14) and 28-week follow-up visits.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Blood draw (minimally invasive); MRI scan (non-invasive); Thinking & memory tests (non-invasive); Brain wave recording (EEG) (non-invasive); Walking & movement tests (non-invasive). Confirm the full schedule with the study coordinator.
- Is there a medication washout in this trial?
- The two 6-week training cycles are separated by an 8-week washout period.