An interventional study of Foot Mechanical Stimulation (Gondola®, CE marking n° 0476) in Parkinson's Disease, Autonomic Neuropathy and Inflammation, sponsored by Istituto Clinico Humanitas. Completed at 1 site in Italy. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-03.
Sponsored by Istituto Clinico Humanitas · Not applicable, Interventional, and Supportive care
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.
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:
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This study's enrollment of 50 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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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.
Device: Foot Mechanical Stimulation (Gondola®, CE marking n° 0476)
The feet mechanical stimulation will be performed by Gondola (Gondola®, CE marking n° 0476).
Also known as: Pressure-controlled mechanical stimulator (Gondola®)
Changes of Pentraxin 3 (PTX3) plasma levels induced by feet mechanical stimulation.
PTX3 as an index of systemic inflammatory profile will be assessed by a developed and optimized ELISA and expressed by ng/ml.
Time frame: Blood samples will be collected at Baseline, and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of Interleukine-6 (IL-6), plasma levels induced by feet mechanical stimulation.
IL-6 will be tested by commercially available ELISA and immunoturbidimetric assays and expressed by ng/ml.
Time frame: Blood samples will be collected at Baseline, and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of Tumor Necrosis Factor (TNF) plasma levels induced by feet mechanical stimulation.
TNF will be tested by commercially available ELISA and immunoturbidimetric assays and expressed by ng/ml.
Time frame: Blood samples will be collected at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of C Reactive Protein (CRP) plasma levels induced by feet mechanical stimulation.
CRP will be tested by commercially available ELISA and immunoturbidimetric assays and expressed by mg/dl.
Time frame: Blood samples will be collected at Baseline, and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of Heart Rate (HR) values in supine position induced by feet mechanical stimulation.
Mean value of 15 minute-ECG continuous recording in supine position will be used.
Time frame: HR will be assessed in beats/min at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of Blood Pressure (BP) values in supine position induced by feet mechanical stimulation.
Mean value of 5 measures obtained every 3 minutes by an Automatic-cycling non-invasive blood pressure monitor in supine position will be used.
Time frame: BP will be assessed in mmHg at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of the index of cardiac vagal modulation (HFRR, High Frequency oscillatory component of R-R interval (RR) variability at ~0.25Hz) in supine position induced by feet mechanical stimulation.
HFRR will be obtained by the spectral analysis of R-R interval spontaneous variability in supine position.
Time frame: HFRR will be assessed in msec2 at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of the index of cardiac sympathetic modulation (LFRR, Low Frequency oscillatory component of R-R interval variability at ~0.10 Hz) in supine position induced by feet mechanical stimulation.
LFRR will be obtained by the spectral analysis of R-R interval spontaneous variability in supine position.
Time frame: LFRR will be assessed in msec2 at baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of the index of cardiac sympatho-vagal modulation (LF/HF)RR in supine position induced by feet mechanical stimulation.
LF/HF is the ratio between LFRR index of cardiac sympathetic modulation and HFRR index of the cardiac vagal modulation obtained by the spectral analysis of R-R interval spontaneous variability.
Time frame: LF/HF (unit-less value) will be assessed at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of the index of sympathetic modulation to the vessels (LFSAP) in supine position induced by by feet mechanical stimulation.
LFSAP will be quantified by spectral analysis of systolic arterial pressure variability obtained by beat by beat blood pressure non-invasive continuous recording in supine position.
Time frame: LFSAP will be assessed in mmHg2 at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of plasma Norepinephrine (NE) in supine position induced by feet mechanical stimulation.
Plasma NE will be quantified by High Performance Liquid Chromatography (HPLC) with electrochemical detection (ED) from blood samples collected in supine position
Time frame: Plasma NE will be assessed in ng/L at baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of plasma Epinephrine (E) in supine position induced by feet mechanical stimulation.
Plasma E will be quantified by High Performance Liquid Chromatography (HPLC) and electrochemical detection (ED) from blood samples collected in supine position
Time frame: Plasma E will be quantified in ng/L at baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of Heart Rate (HR beats/min) values during 75°head-up tilt induced by feet mechanical stimulation.
The mean value of 15 minute-ECG continuous recording during 75°head-up tilt will be used.
Time frame: HR will be assessed in beats/min at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of Blood Pressure (BP) values during 75°head-up tilt induced by feet mechanical stimulation.
The mean value of 5 measures obtained every 3 minutes by an automatic-cycling non-invasive blood pressure monitor during 75°head-up tilt will be used.
Time frame: BP will be assessed in mmHg at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of the index of cardiac vagal modulation (HFRR, High Frequency oscillatory component of R-R interval variability at ~0.25Hz) during 75°head-up tilt induced by feet mechanical stimulation.
HFRR will be obtained by the spectral analysis of R-R interval spontaneous variability during 75°head-up tilt.
Time frame: HFRR will be assessed in (msec2) at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of the index of cardiac sympathetic modulation (LFRR, Low Frequency oscillatory component of R-R interval variability at ~0.10 Hz) during 75° head-up tilt induced by feet mechanical stimulation.
LFRR will be obtained by the spectral analysis of R-R interval spontaneous variability during 75° head-up tilt.
Time frame: LFRR will be assessed in msec2 at baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of the index of cardiac sympatho-vagal modulation (LF/HF)RR during 75°head-up tilt induced by feet mechanical stimulation.
LF/HF will be quantified as a ratio between LFRR index of cardiac sympathetic modulation and HFRR index of the cardiac vagal modulation obtained by the spectral analysis of R-R interval spontaneous variability during 75°head-up tilt.
Time frame: LF/HF (unit-less value) will be assessed at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of the index of sympathetic modulation to the vessels (LFSAP , mmHg2) during 75°head-up tilt induced by feet mechanical stimulation.
LFSAP expressed will be quantified by spectral analysis of systolic arterial pressure variability obtained by beat by beat blood pressure non-invasive continuous recording during 75°head-up tilt.
Time frame: LFSAP will be assessed in mmHg2 at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of plasma Norepinephrine (NE) during 75°head-up tilt induced by feet mechanical stimulation.
Plasma NE will be evaluated by High Performance Liquid Chromatography (HPLC) with electrochemical detection (ED) from blood samples collected after 5 minutes of 75°head-up tilt.
Time frame: Plasma NE will be quantified in ng/L at baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes of plasmatic Epinephrine (E) during 75°head-up tilt induced by feet mechanical stimulation.
Plasma E will be evaluated by High Performance Liquid Chromatography (HPLC) and electrochemical detection (ED) from blood samples collected after 5 minutes lasting 75°head-up tilt.
Time frame: Plasma E will be quantified in ng/L at baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Changes in Unified Parkinson's Disease Rating Scale (UDPRS) induced by feet mechanical stimulation.
UDPRS will be performed by neurologist
Time frame: UDPRS will be done at baseline and 16 days from baseline, after 5 feet mechanical stimulation sessions
Changes in Timed Up and Go induced by feet mechanical stimulation.
Timed Up and Go test will be performed before and after the feet mechanical stimulations at baseline,72 hours and 16 days from baseline (i.e. after 5 stimulations)
Time frame: Timed Up and Go will be evaluated at Baseline, 72 hours and 16 days from baseline after 5 feet stimulation sessions
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Istituto Clinico Humanitas