Condition: Parkinson Disease · Sponsor: IRCCS San Raffaele
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 been demonstrated to be effective to improve gait and mobility in PD-PIGD), additionally they will undergo SHAM transcranial and trans-spinal stimulation. SHAM stimulation will be performed using the same montage used for transcranial and spinal stimulation (explained below), however an initial current is delivered and programmed to fade off in a brief period of time. The REHAB + STIM group will perform the same exercises combined with non-invasive stimulation. Non-invasive stimulation will be administered using tDCS with trans-spinal Direct Current Stimulation (tsDCS) or transcranial Direct C…
This description comes directly from the study's public registry record.
Federica Agosta, PhD, MD · 0226433051 · agosta.federica@hsr.it
Elisabetta Sarasso, MSc · 0226434685 · sarasso.elisabetta@hsr.it
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| San Raffaele Neurotech Hub | Milan, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06868160