Clinical studies on the AMPS treatment given via the Gondola® device

The effects of the Automated Mechanical Peripheral Stimulation (AMPS) treatment given via the GONDOLA® medical device have been studied in several Clinical Trials conducted by research institutes with international relevance in Parkinson’s disease.

The goal of these research activities is to measure and document the clinical effects induced by the AMPS stimulation on Parkinson’s patients, with specific focus on the benefits obtained on motor symptoms and on balance.

Scientific papers document that AMPS treatment, in Parkinson’s patients, allows to:

  • Improve the functional connectivity between brain regions involved in visuo-spatial and sensory-motor integration.
  • Obtain immediate benefits in the main motor skills, inducing improved walking speed, step length, propulsion and balance.
  • Obtain larger improvements when Parkinson’s symptoms are more advanced.
  • Maintain the benefits for a duration of 3-5 days after the stimulation; interruption of the GONDOLA applications causes loss of the benefits and come back of the motor disabilities.
  • Maintain benefits over time with regular use of the device.

The AMPS treatment improves the functional connectivity of brain regions involved in visuo-spatial and sensory-motor integration.

15 Ottobre 2015
In this Clinical Study 11 patients with idiopathic Parkinson’s disease have been enrolled and effects of the AMPS treatment have been measured using fMRI and traditional clinical evaluations.

The study has been designed with placebo control in crossover, meaning that all patients have received – in different times – both an effective AMPS treatment and a placebo AMPS treatment.

Study results show that the effective AMPS treatment – and not the placebo AMPS treatment – is effective in inducing an increased functional connectivity of important brain regions.

More specifically, study results show that the AMPS treatment induces an increased activation of brain areas involved in the visual-space and in the sensory-motor integration.

These important results are of big help in understanding the mechanism of action underlying the AMPS treatment, and in explaining how this treatment can induce the clinical benefits on motor symptoms and Freezing of Gait.

The study has been designed by Maria Francesca De Pandis, MD PHD, Director of the Parkinson’s Center at San Raffaele Cassino Hospital, conducted by Carlo Cosimo Quattrocchi, MD, Researcher in Neuroradiology at Università Campus Biomedico of Rome, and directed by Fabrizio Stocchi, MD PHD, Director of the Movement Disorders Research Center at IRCCS San Raffaele Pisana in Rome.

An important contribution to the study came from the Department of Electronics, Information and Bioengineering – DEIB – of Milan Polytechnic.

Regular repetition of GONDOLA® stimulations allows to maintain benefits over time.

Long term effects of the AMPS treatment on walking.

24 may 2015
In this Clinical Study have been enrolled 18 Parkinson’s patients with the goal of verifying the long term effects of the AMPS treatment on specific motor parameters (step length, walking speed, double support time).

Each patient received six AMPS treatments via the GONDOLA medical device (two treatments per week, for a total duration of three weeks); analyzed parameters have been acquired before and after the 1st stimulation and after the 6th one; follow-up measurements have been performed 48 hours and 10 days after the last stimulation, to study how long the benefits deriving from the treatment last.

The study has allowed to document the positive effects of the AMPS therapy on bradykinesia (or slowness of movement, a symptom very common in Parkinson’s patients); the improvements were obtained thanks to both an increase of walking speed and of step length.

The study has also allowed to document that the GONDOLA® device induces an improvement in balance during walking.

It’s interesting to observe that regular repetition of the AMPS therapy twice a week allows patients to maintain the improvements, while the interruption of the treatments causes a steady return towards the initial status, with a regression of benefits and return of symptoms; this means that, in order to maintain benefits, the treatment has to be repeated regularly twice a week.

The study has been directed by Fabrizio Stocchi, MD PhD (Director of the Movement Disorders Research Center at IRCCS San Raffaele Pisana in Rome), designed by Maria Francesca De Pandis, MD PhD (Director of the Parkinson’s Center at San Raffaele Cassino Hospital), and has been conducted with the support of the Department of Electronics, Information and Bioengineering – DEIB – of Milan Polytechnic.

The AMPS treatment is effective in reducing the risk of falls

Timed Up and Go test and wearable inertial sensor: a new combined tool to assess changes in Parkinson’s patients following Automated Mechanical Peripheral Stimulation

11 maggio 2015
The test Timed Up and Go (TUG) is a clinical test commonly used to measure the risk of falling; the patient sits in the chair with his/her back against the chair back, then, on the command “go”, he/she rises from the chair, walks 3 meters, turns, walks back to the chair and sits down.

The time needed to perform the single actions that compose the test is recorded, together with speed and acceleration.

A result of 10 seconds indicates a normal mobility, between 11 and 20 seconds are within normal limits for older people, while a result greater than 20 seconds indicates that the subject needs assistance; completing the test in 14 seconds or more indicates a higher risk of falling.

In this Clinical Study the test has been done before and after the AMPS treatment given via the GONDOLA medical device; a group of 15 patients have been enrolled, and they have been observed in “off medication” status.

Study results show that the GONDOLA treatment has a positive effect on slowness of movement (bradykinesia) and induces a better movement, increased step length and better stability during walk; additionally, the treatment also allows the reduction of double support phase during the walk, a very important parameter that correlates with higher stability and better balance.

It is important to underline that some of the measured parameters showed improvements in excess of 50% compared to the basal performance, and it is also interesting to highlight that the improvements were available right after the AMPS treatment.

Prof. Fabrizio Stocchi, MD PhD (Director of the Movement Disorders Research Center at IRCCS San Raffaele Pisana in Rome) has been the principal investigator of the study, that has been designed by Maria Francesca De Pandis, MD PhD (Director of the Parkinson’s Center at San Raffaele Cassino Hospital), and has been conducted with the support of the Department of Electronics, Information and Bioengineering – DEIB – of Milan Polytechnic.

The GONDOLA treatment is more effective in advanced stages of Parkinson’s Disease

The Parkinsonian gait spatiotemporal parameters quantified by a single inertial sensor before and after Automated Mechanical Peripheral Stimulation treatment

2 sept 2015
This Clinical Study has been conducted to measure the spatiotemporal modification of gait induced by the AMPS treatment in Parkinson’s patients.

In the study the correlation between the clinical status of the patients and the entity of the improvements induced by the GONDOLA treatment has been studied.

In this study have been enrolled 35 patients in different stages of the disease (based on the Hoehn & Yahr measurement); all participants have been treated with AMPS stimulation given via the GONDOLA device.

The measurements have been done before and after the treatment.

The study outcomes show that the AMPS treatment allows to improve gait spatiotemporal parameters in Parkinson’s patients; it is noteworthy that results show a positive correlation between the progression of the disease (the severity of the motor symptoms affecting patients) and the magnitude of the improvements induced by the AMPS treatment: this means that patients who are experiencing more disabling symptoms are those who can benefit more of using the GONDOLA device.

The study has been conducted by IRCCS San Raffaele Pisana in the Rome and Cassino centers, with the participation of the Department of Electronics, Information and Bioengineering – DEIB – of Milan Polytechnic.

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