Comparing non-invasive electrical stimulation plus rehabilitation to improve balance and walking in Parkinson's disease
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
This study will test whether adding different types of non-invasive electrical stimulation to gait and balance training helps people with Parkinson's disease who have postural instability and walking problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 71 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06868160 on ClinicalTrials.gov |
What this trial studies
Adults with Parkinson's disease and postural instability/gait disorder (PD-PIGD) and age- and sex-matched healthy controls undergo baseline neurological, cognitive, gait/balance, neuroimaging (MRI), fNIRS, EEG, and blood assessments. PD-PIGD participants are randomized to two groups: REHAB+SHAM (dual-task gait/balance training with action observation and motor imagery plus sham stimulation) or REHAB+STIM (same training combined with active non-invasive electrical stimulation including tDCS and transcutaneous spinal DCS across two cycles). The protocol includes repeated training cycles with neurophysiological and imaging measures to track brain activity, connectivity, and structural changes over the observation period. Outcomes focus on gait and balance performance, biomarkers from imaging/EEG/fNIRS, and safety/tolerability of stimulation paired with rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are people aged 45–85 with idiopathic Parkinson's disease of the PIGD phenotype, Hoehn & Yahr stage ≤4, stable dopaminergic medication, no dementia (MMSE ≥24), and able to undergo MRI and stimulation procedures.
Not a fit: Patients with major systemic, psychiatric, visual, musculoskeletal or other causes of walking inability, implanted electronic devices (e.g., pacemaker), uncontrolled medical conditions, or dementia are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, combining targeted electrical stimulation with gait and balance training could improve walking, reduce falls, and enhance mobility for patients with PD-PIGD.
How similar studies have performed: Previous small studies have shown promise for action observation/motor imagery and for noninvasive brain or spinal stimulation separately, but combining spinal and cranial stimulation with this rehab program is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 45 years \< age ≤ 85 years * Idiopathic PD according to the Movement Disorders Society (MDS) diagnostic criteria * Hoehn \& Yahr (H\&Y) score ≤ 4 * PIGD phenotype * Stable dopaminergic medication for at least 4 weeks and without any changes during the observation period (28 weeks) * No dementia according to Litvan\'s criteria and Mini-Mental Status Examination score (MMSE) ≥ 24 * No significant tremor/involuntary movements that could determine artifacts during the MRI acquisition * Oral and written informed consent to study participation Healthy controls' inclusion criteria: * Sex-matched and age-matched (age range: mean age of PD years ± 15 years) * Oral and written informed consent to study participation Exclusion Criteria: * Any major systemic, psychiatric, neurological, visual, and musculoskeletal disturbances or other causes of walking inability * Medical conditions or substance abuse that could interfere with cognition * Pacemaker or other implanted neurostimulation devices in the head/neck district * (Other) Contraindications to undergoing MRI examination * Brain damage at routine MRI, including extensive cerebrovascular disorders * Denied oral and written informed consent to study participation * Significant scalp traumatic or surgical wounds or scalp alterations that could determine a risk of infection in the site of non-invasive stimulation or the spread of excessive current from the device (only for patients receiving the neurostimulation).
Where this trial is running
Milan
- San Raffaele Neurotech Hub — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Federica Agosta, PhD, MD
- Email: agosta.federica@hsr.it
- Phone: 0226433051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.