Parkinson's Diseaseparkgo-1NCT02608424

Effects of Feet Mechanical Stimulation on Cardiovascular Autonomic Profile and Inflammation in Parkinson's Disease

A study testing Foot Mechanical Stimulation (Gondola®, CE marking n° 0476) in people with Parkinson's Disease and Autonomic Neuropathy, run by Istituto Clinico Humanitas at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 50 to 80 years
Conditions the study is for: Parkinson's Disease, Autonomic Neuropathy, Inflammation
What is being tested?: Foot Mechanical Stimulation (Gondola®, CE marking n° 0476)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteItaly
Study dates: Mar 2015to Aug 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Show all 9Show fewer

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 locations and contacts

1 site in 1 country.

Italy1 site

Humanitas Research Hospital
Rozzano, 20089

Other trials in Italy

About this study

Official title: Effects of Feet Mechanical Stimulation on the Inflammatory State and Cardiovascular Autonomic Profile in Patients With Parkinson's Disease

Read the detailed 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.

Conditions: Parkinson's Disease, Autonomic Neuropathy, Inflammation, Hypertension
Being tested: Foot Mechanical Stimulation (Gondola®, CE marking n° 0476)
Keywords: Foot mechanical stimulation, Autonomic nervous system, Inflammation, Parkinson's disease, Spectral analysis, Heart rate variability, Blood pressure variability
Medical subject headings: Parkinson Disease, Inflammation, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Foot Mechanical Stimulation (Gondola®, CE marking n° 0476)Device
Also called Pressure-controlled mechanical stimulator (Gondola®)
The feet mechanical stimulation will be performed by Gondola (Gondola®, CE marking n° 0476).

Study groups in NCT02608424
Study group	Role	What they receive
Foot Mechanical Stimulation	Experimental	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. Receives: Device: Foot Mechanical Stimulation (Gondola®, CE marking n° 0476)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Plasma E will be quantified in ng/L at baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).

Secondary outcomes (2)

Changes in Unified Parkinson's Disease Rating Scale (UDPRS) induced by feet mechanical stimulation.
UDPRS will be performed by neurologist
Measured: 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)
Measured: Timed Up and Go will be evaluated at Baseline, 72 hours and 16 days from baseline after 5 feet stimulation sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Aug 2017

First posted18 Nov 2015 (estimated)
Study startMar 2015
Primary completionAug 2016
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02608424
Sponsor's protocol ID: parkgo-1-ICH
Acronym: parkgo-1
Status last verified: Aug 2018
First submitted: 27 Oct 2015
Last updated: 3 Aug 2018
Results posted: No
Data monitoring committee: No

Publications

Barbic F, Perego F, Canesi M, Gianni M, Biagiotti S, Costantino G, Pezzoli G, Porta A, Malliani A, Furlan R. Early abnormalities of vascular and cardiac autonomic control in Parkinson's disease without orthostatic hypotension. Hypertension. 2007 Jan;49(1):120-6. doi: 10.1161/01.HYP.0000250939.71343.7c. Epub 2006 Nov 13.
PubMed 17101845
Barbic F, Galli M, Dalla Vecchia L, Canesi M, Cimolin V, Porta A, Bari V, Cerri G, Dipaola F, Bassani T, Cozzolino D, Pezzoli G, Furlan R. Effects of mechanical stimulation of the feet on gait and cardiovascular autonomic control in Parkinson's disease. J Appl Physiol (1985). 2014 Mar 1;116(5):495-503. doi: 10.1152/japplphysiol.01160.2013. Epub 2014 Jan 16.
PubMed 24436294
Lee HW, Choi J, Suk K. Increases of pentraxin 3 plasma levels in patients with Parkinson's disease. Mov Disord. 2011 Nov;26(13):2364-70. doi: 10.1002/mds.23871. Epub 2011 Sep 23.
PubMed 21953577
Lee JK, Tran T, Tansey MG. Neuroinflammation in Parkinson's disease. J Neuroimmune Pharmacol. 2009 Dec;4(4):419-29. doi: 10.1007/s11481-009-9176-0. Epub 2009 Oct 10.
PubMed 19821032
Furlan R, Ardizzone S, Palazzolo L, Rimoldi A, Perego F, Barbic F, Bevilacqua M, Vago L, Bianchi Porro G, Malliani A. Sympathetic overactivity in active ulcerative colitis: effects of clonidine. Am J Physiol Regul Integr Comp Physiol. 2006 Jan;290(1):R224-32. doi: 10.1152/ajpregu.00442.2005. Epub 2005 Aug 25.
PubMed 16123227
Borovikova LV, Ivanova S, Zhang M, Yang H, Botchkina GI, Watkins LR, Wang H, Abumrad N, Eaton JW, Tracey KJ. Vagus nerve stimulation attenuates the systemic inflammatory response to endotoxin. Nature. 2000 May 25;405(6785):458-62. doi: 10.1038/35013070.
PubMed 10839541
Gademan MG, Sun Y, Han L, Valk VJ, Schalij MJ, van Exel HJ, Lucas CM, Maan AC, Verwey HF, van de Vooren H, Pinna GD, Maestri R, La Rovere MT, van der Wall EE, Swenne CA. Rehabilitation: Periodic somatosensory stimulation increases arterial baroreflex sensitivity in chronic heart failure patients. Int J Cardiol. 2011 Oct 20;152(2):237-41. doi: 10.1016/j.ijcard.2010.07.022. Epub 2010 Aug 9.
PubMed 20691484
de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006 Jun;5(6):525-35. doi: 10.1016/S1474-4422(06)70471-9.
PubMed 16713924
Emre M. Dementia associated with Parkinson's disease. Lancet Neurol. 2003 Apr;2(4):229-37. doi: 10.1016/s1474-4422(03)00351-x.
PubMed 12849211
Huse DM, Schulman K, Orsini L, Castelli-Haley J, Kennedy S, Lenhart G. Burden of illness in Parkinson's disease. Mov Disord. 2005 Nov;20(11):1449-54. doi: 10.1002/mds.20609.
PubMed 16007641
Findley LJ. The economic impact of Parkinson's disease. Parkinsonism Relat Disord. 2007 Sep;13 Suppl:S8-S12. doi: 10.1016/j.parkreldis.2007.06.003. Epub 2007 Aug 16.
PubMed 17702630
Allcock LM, Ullyart K, Kenny RA, Burn DJ. Frequency of orthostatic hypotension in a community based cohort of patients with Parkinson's disease. J Neurol Neurosurg Psychiatry. 2004 Oct;75(10):1470-1. doi: 10.1136/jnnp.2003.029413.
PubMed 15377699
Pratorius B, Kimmeskamp S, Milani TL. The sensitivity of the sole of the foot in patients with Morbus Parkinson. Neurosci Lett. 2003 Aug 7;346(3):173-6. doi: 10.1016/s0304-3940(03)00582-2.
PubMed 12853112
Bernardi L, Bissa M, DeBarbieri G, Bharadwaj A, Nicotra A. Arterial baroreflex modulation influences postural sway. Clin Auton Res. 2011 Jun;21(3):151-60. doi: 10.1007/s10286-010-0099-x. Epub 2010 Dec 24.
PubMed 21184247
Schmidt C, Berg D; Herting; Prieur S, Junghanns S, Schweitzer K, Globas C, Schols L, Reichmann H, Ziemssen T. Loss of nocturnal blood pressure fall in various extrapyramidal syndromes. Mov Disord. 2009 Oct 30;24(14):2136-42. doi: 10.1002/mds.22767.
PubMed 19768815

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Feet Mechanical Stimulation on the Inflammatory State and Cardiovascular Autonomic Profile in Patients With Parkinson's Disease
ClinicalTrials.gov ID: NCT02608424
Acronym / sponsor ID: parkgo-1 / parkgo-1-ICH
Conditions: Parkinson's Disease, Autonomic Neuropathy, Inflammation, Hypertension
Keywords: Foot mechanical stimulation, Autonomic nervous system, Inflammation, Parkinson's disease, Spectral analysis, Heart rate variability, Blood pressure variability
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Istituto Clinico HumanitasUniversity, hospital or other
Study start: Mar 2015 (actual)
Primary completion: Aug 2016 (actual)
Study completion: Aug 2017 (actual)
First posted: 18 Nov 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Foot Mechanical Stimulation	Experimental	Device: Foot Mechanical Stimulation (Gondola®, CE marking n° 0476)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.

Who may qualify

Ages: 50 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Foot Mechanical Stimulation (Gondola®, CE marking n° 0476)Also: Pressure-controlled mechanical stimulator (Gondola®)The feet mechanical stimulation will be performed by Gondola (Gondola®, CE marking n° 0476).	Device	Foot Mechanical Stimulation

Primary outcome

Changes of Pentraxin 3 (PTX3) plasma levels induced by feet mechanical stimulation.
Time frame: Blood samples will be collected at Baseline, and 16 days from baseline (after 5 feet mechanical stimulation sessions).
PTX3 as an index of systemic inflammatory profile will be assessed by a developed and optimized ELISA and expressed by ng/ml.
Changes of Interleukine-6 (IL-6), plasma levels induced by feet mechanical stimulation.
Time frame: Blood samples will be collected at Baseline, and 16 days from baseline (after 5 feet mechanical stimulation sessions).
IL-6 will be tested by commercially available ELISA and immunoturbidimetric assays and expressed by ng/ml.
Changes of Tumor Necrosis Factor (TNF) plasma levels induced by feet mechanical stimulation.
Time frame: Blood samples will be collected at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
TNF will be tested by commercially available ELISA and immunoturbidimetric assays and expressed by ng/ml.
Changes of C Reactive Protein (CRP) plasma levels induced by feet mechanical stimulation.
Time frame: Blood samples will be collected at Baseline, and 16 days from baseline (after 5 feet mechanical stimulation sessions).
CRP will be tested by commercially available ELISA and immunoturbidimetric assays and expressed by mg/dl.
Changes of Heart Rate (HR) values in supine position induced by feet mechanical stimulation.
Time frame: HR will be assessed in beats/min at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Mean value of 15 minute-ECG continuous recording in supine position will be used.
Changes of Blood Pressure (BP) values in supine position induced by feet mechanical stimulation.
Time frame: BP will be assessed in mmHg at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Mean value of 5 measures obtained every 3 minutes by an Automatic-cycling non-invasive blood pressure monitor in supine position will be used.
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.
Time frame: HFRR will be assessed in msec2 at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
HFRR will be obtained by the spectral analysis of R-R interval spontaneous variability in supine position.
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.
Time frame: LFRR will be assessed in msec2 at baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
LFRR will be obtained by the spectral analysis of R-R interval spontaneous variability in supine position.
Changes of the index of cardiac sympatho-vagal modulation (LF/HF)RR in supine position induced by feet mechanical stimulation.
Time frame: LF/HF (unit-less value) will be assessed at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
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.
Changes of the index of sympathetic modulation to the vessels (LFSAP) in supine position induced by by feet mechanical stimulation.
Time frame: LFSAP will be assessed in mmHg2 at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
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.
Changes of plasma Norepinephrine (NE) in supine position induced by feet mechanical stimulation.
Time frame: Plasma NE will be assessed in ng/L at baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Plasma NE will be quantified by High Performance Liquid Chromatography (HPLC) with electrochemical detection (ED) from blood samples collected in supine position
Changes of plasma Epinephrine (E) in supine position induced by feet mechanical stimulation.
Time frame: Plasma E will be quantified in ng/L at baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
Plasma E will be quantified by High Performance Liquid Chromatography (HPLC) and electrochemical detection (ED) from blood samples collected in supine position
Changes of Heart Rate (HR beats/min) values during 75°head-up tilt induced by feet mechanical stimulation.
Time frame: HR will be assessed in beats/min at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
The mean value of 15 minute-ECG continuous recording during 75°head-up tilt will be used.
Changes of Blood Pressure (BP) values during 75°head-up tilt induced by feet mechanical stimulation.
Time frame: BP will be assessed in mmHg at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
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.
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.
Time frame: HFRR will be assessed in (msec2) at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
HFRR will be obtained by the spectral analysis of R-R interval spontaneous variability during 75°head-up tilt.
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.
Time frame: LFRR will be assessed in msec2 at baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
LFRR will be obtained by the spectral analysis of R-R interval spontaneous variability during 75° head-up tilt.
Changes of the index of cardiac sympatho-vagal modulation (LF/HF)RR during 75°head-up tilt induced by feet mechanical stimulation.
Time frame: LF/HF (unit-less value) will be assessed at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
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.
Changes of the index of sympathetic modulation to the vessels (LFSAP , mmHg2) during 75°head-up tilt induced by feet mechanical stimulation.
Time frame: LFSAP will be assessed in mmHg2 at Baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
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.
Changes of plasma Norepinephrine (NE) during 75°head-up tilt induced by feet mechanical stimulation.
Time frame: Plasma NE will be quantified in ng/L at baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
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.
Changes of plasmatic Epinephrine (E) during 75°head-up tilt induced by feet mechanical stimulation.
Time frame: Plasma E will be quantified in ng/L at baseline and 16 days from baseline (after 5 feet mechanical stimulation sessions).
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.

2 secondary outcomes

Changes in Unified Parkinson's Disease Rating Scale (UDPRS) induced by feet mechanical stimulation.
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.
Time frame: Timed Up and Go will be evaluated at Baseline, 72 hours and 16 days from baseline after 5 feet stimulation sessions

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
Background: PubMed 17101845Barbic F, Perego F, Canesi M, Gianni M, Biagiotti S, Costantino G, Pezzoli G, Porta A, Malliani A, Furlan R. Early abnormalities of vascular and cardiac autonomic control in Parkinson's disease without orthostatic hypotension. Hypertension. 2007 Jan;49(1):120-6. doi: 10.1161/01.HYP.0000250939.71343.7c. Epub 2006 Nov 13.
Background: PubMed 24436294Barbic F, Galli M, Dalla Vecchia L, Canesi M, Cimolin V, Porta A, Bari V, Cerri G, Dipaola F, Bassani T, Cozzolino D, Pezzoli G, Furlan R. Effects of mechanical stimulation of the feet on gait and cardiovascular autonomic control in Parkinson's disease. J Appl Physiol (1985). 2014 Mar 1;116(5):495-503. doi: 10.1152/japplphysiol.01160.2013. Epub 2014 Jan 16.
Background: PubMed 21953577Lee HW, Choi J, Suk K. Increases of pentraxin 3 plasma levels in patients with Parkinson's disease. Mov Disord. 2011 Nov;26(13):2364-70. doi: 10.1002/mds.23871. Epub 2011 Sep 23.
Background: PubMed 19821032Lee JK, Tran T, Tansey MG. Neuroinflammation in Parkinson's disease. J Neuroimmune Pharmacol. 2009 Dec;4(4):419-29. doi: 10.1007/s11481-009-9176-0. Epub 2009 Oct 10.
Background: PubMed 16123227Furlan R, Ardizzone S, Palazzolo L, Rimoldi A, Perego F, Barbic F, Bevilacqua M, Vago L, Bianchi Porro G, Malliani A. Sympathetic overactivity in active ulcerative colitis: effects of clonidine. Am J Physiol Regul Integr Comp Physiol. 2006 Jan;290(1):R224-32. doi: 10.1152/ajpregu.00442.2005. Epub 2005 Aug 25.
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Background: PubMed 20691484Gademan MG, Sun Y, Han L, Valk VJ, Schalij MJ, van Exel HJ, Lucas CM, Maan AC, Verwey HF, van de Vooren H, Pinna GD, Maestri R, La Rovere MT, van der Wall EE, Swenne CA. Rehabilitation: Periodic somatosensory stimulation increases arterial baroreflex sensitivity in chronic heart failure patients. Int J Cardiol. 2011 Oct 20;152(2):237-41. doi: 10.1016/j.ijcard.2010.07.022. Epub 2010 Aug 9.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Raffaello Furlan, MD study director

Humanitas Research Hospital, University of Milan

Raffaello Furlan, MD study chair

Humanitas Rsearch Hospital, University of Milan

Franca Barbic, MD principal investigator

Humanitas Research Hospital; Humanitas University, Rozzano (MI)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Foot Mechanical Stimulation (Gondola®, CE marking n° 0476) in people with Parkinson's Disease and Autonomic Neuropathy, run by Istituto Clinico Humanitas at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of Pentraxin 3 (PTX3) plasma levels induced by feet mechanical stimulation. (time frame: Blood samples will be collected at Baseline, and 16 days from baseline (after 5 feet mechanical stimulation sessions).). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02608424, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.