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Comparison of Different Non-invasive Electrical Stimulation Protocols to Facilitate Rehabilitation in Parkinson's Disease Subjects With Postural Instability and Gait Disorders

RecruitingNAAges 45 Years - 85 YearsAllIRCCS San Raffaele
NCT06868160 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The trial will include 51 adult participants with Parkinson's disease and postural instability and gait disorders (PD-PIGD) and 20 age- and sex-matched healthy controls. At baseline (T0) patients will undergo neurological and cognitive/behavioural assessments, gait/balance evaluation, neuroimaging/neurophysiology assessments including brain magnetic resonance imaging (MRI), functional Near Infrared Spectroscopy (fNIRS) and Electroencephalography (EEG) acquisitions to assess brain activity, connectivity and structural changes, and blood sample. PD-PIGD patients will be randomly allocated in two training groups: the REHAB+SHAM group and the REHAB + STIM group. The REHAB+SHAM group will perform 2 cycles of dual-task gait/balance training consisting of action observation training (AOT) and motor imagery (MI) combined with practicing the observed-imagined exercises (an approach that has be

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📋 Eligibility rules (as published)
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).
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What it tests

  • Rehabilitation
  • SHAM tDCS
  • tDCS
  • tsDCS (first cycle)
  • tsDCS (second cycle)
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Where

1 site
San Raffaele Neurotech Hub
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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