Effects of Feet Mechanical Stimulation on Cardiovascular Autonomic Profile and Inflammation in Parkinson's Disease (parkgo-1)
Parkinson's Disease, Autonomic Neuropathy, Inflammation
About this trial
This is an interventional supportive care trial for Parkinson's Disease focused on measuring Foot mechanical stimulation, Autonomic nervous system, Inflammation, Parkinson's disease, Spectral analysis, Heart rate variability, Blood pressure variability
Eligibility Criteria
Inclusion Criteria:
- Idiopathic PD characterized by a moderate/important motor impairment (Hoehn&Yhar scale 2-4)
- PD will be diagnosed according to the United Kingdom (UK) Parkinson's Disease Society Brain Bank criteria, (or on the basis of clinical criteria, Dopamine Transporter (DAT)- scan and/or MRI).
Exclusion Criteria:
- Dysautonomias and other neurodegenerative diseases
- History/familiarity with seizures
- Atrial fibrillation and other relevant cardiac rhythm disturbances
- Chronic inflammatory diseases and chronic use on anti-inflammatory drugs
- Diabetes
- Other neurological or psychiatric diseases
- Pacemakers or other electronic implants inserted into the body
- Coronary disorders, elevated intracranial blood pressure
- Assumption of drugs facilitating seizures, psychiatric drugs, alcohol abuse
Sites / Locations
- Humanitas Research Hospital
Arms of the Study
Arm 1
Experimental
Foot Mechanical Stimulation
Intervention: Foot Mechanical Stimulation (FMS) will be performed on enrolled patients every 72 hours (total 5 stimulation sessions) by a pressure-controlled mechanical stimulator (Gondola®, European Community (CE) marking n° 0476) . The sites of the stimulation will be the tip of the hallux and the lower big toe first metatarsal joint plantar surface. The FMS procedure consists in the application of the patient's calibrated pressure for 6 seconds, over the selected sites. Each of the 2 cutaneous sites of both feet will be mechanically stimulated. The procedure will be automatically repeated for 4 times in every subject so that the overall time of stimulation will be approximately 2 minutes.