Effects of Feet Mechanical Stimulation on Cardiovascular Autonomic Profile and Inflammation in Parkinson's Disease (parkgo-1)

Istituto Clinico Humanitas

Status: Completed

Conditions: Autonomic Neuropathy; Hypertension; Inflammation; Parkinson's Disease

Treatments: Device: Foot Mechanical Stimulation (Gondola®, CE marking n° 0476)

Study type: Interventional

Funder types: Other

Identifiers

NCT02608424

parkgo-1-ICH

Details and patient eligibility

About

In the present study, investigators test the hypothesis that a controlled mechanical pressure applied on specific sites of both fore-feet (ES) can reduce the inflammatory state and arterial blood pressure in patients with Parkinson's Disease by increasing the overall parasympathetic activity and reducing vascular sympathetic modulation.

Full description

Neuroinflammation may contribute to the cascade of events leading to neuronal loss in Parkinson's disease (PD) thus facilitating motor and autonomic impairment. A link between autonomic function and chronic and acute inflammation has been previously described. Specifically, active inflammatory state was associated with an overall increased sympathetic tone, whereas the parasympathetic cholinergic activation seemed to promote a decrease of inflammatory compounds in inflamed tissues. In addition, a functional link between peripheral sensory afferents and autonomic control has been reported. In a recent study it was observed that in PD patients a somatosensory activation by mechanical stimulation of specific sites of the fore-foot (effective stimulus, ES), improved gait, increased cardiac vagal modulation and decreased vascular sympathetic activity at rest. This latter effect was associated with a decline in arterial blood pressure values.

The present study is aimed at:

• Addressing the magnitude of the inflammatory state in PD patients.
• Testing the hypothesis that a change in the autonomic profile of PD patients induced by ES, consistent with cardiovascular increased parasympathetic and decreased sympathetic activities, may promote an overall reduction of the PD inflammatory state.

Enrollment: 50 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Foot Mechanical Stimulation

Experimental group

Description:

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.

Treatment:

Device: Foot Mechanical Stimulation (Gondola®, CE marking n° 0476)