Comparing non-invasive electrical stimulation plus rehabilitation to improve balance and walking in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• San Raffaele Neurotech Hub
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Federica Agosta, PhD, MD
• Email: agosta.federica@hsr.it
• Phone: 0226433051

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.