Die Wirkungen von GONDOLA^® AMPS (Automated Mechanical Peripheral Stimulation)

To date, the Gondola Medical team and its academic research partners have published ten peer-reviewed clinical study articles in a variety of internationally-renowned journals. The goals of these clinical studies has been to document the safety and efficacy of the GONDOLA^{^®} AMPS device and to understand the physiological benefits of AMPS treatments on various systems of the body, specifically in the Parkinson’s disease (PD) population.

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AMPS treatments improve walking abilities

While Parkinson’s Disease (PD) affects each patient uniquely, movement-related symptoms, including walking difficulties, are ubiquitous. With limited options for treatments of such symptoms, the GONDOLA^® AMPS device is a promising therapy opportunity for PD patients. In eight clinical studies, over 200 PD patients have been tested for walking-related changes after using AMPS treatments^1-8. Overall, the studies indicate that AMPS treatments result in increased walking speed^1-8, increased stride length^1-8, more symmetrical gait^1,7, and improved turning capabilities^1,2.

As part of robust clinical investigation, a “sham” AMPS treatment was administered to similar PD patients and such walking improvements were not observed, thus ruling out any placebo effect. Furthermore, the walking improvements from AMPS treatments have been corroborated in both the ON¹ and OFF^2-8 medication conditions in PD patients with or without freezing or shuffling of gait symptoms^5-7.

Together, the clinical studies suggest that GONDOLA^® AMPS treatments can help patients with a wide range PD presentations regain walking ability and independence.

Barbic F, Galli M, Vecchia LD, et al. Effects of mechanical stimulation of the feet on gait and cardiovascular autonomic control in Parkinson’s disease. J Appl Physiol. 2014;116(5):495-503.
Galli M, Kleiner A, Gaglione M, et al. Timed Up and Go test and wearable inertial sensor: a new combining tool to assess change in subject with Parkinson’s disease after automated mechanical peripheral stimulation treatment. Int J Eng Innov Technol. 2015;4(11):155-163.
Stocchi F, Sale P, Kleiner AFR, et al. Long-term effects of automated mechanical peripheral stimulation on gait patterns of patients with Parkinson’s disease. Int J Rehabil Res. 2015;38(3):238-245.
Kleiner A, Galli M, Gaglione M, et al. The Parkinsonian Gait Spatiotemporal Parameters Quantified by a Single Inertial Sensor before and after Automated Mechanical Peripheral Stimulation Treatment. Parkinsons Dis. 2015;2015.
Pinto C, Pagnussat AS, Rozin Kleiner AF, et al. Automated Mechanical Peripheral Stimulation Improves Gait Parameters in Subjects with Parkinson Disease and Freezing of Gait: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2018;97(6):383-389.
Pagnussat AS, Kleiner AFR, Rieder CRM, et al. Plantar stimulation in parkinsonians: From biomarkers to mobility – Randomized-controlled trial. Restor Neurol Neurosci. 2018;36(2):195-205.
Kleiner AFR, Souza Pagnussat A, Pinto C, Redivo Marchese R, Salazar AP, Galli M. Automated Mechanical Peripheral Stimulation Effects on Gait Variability in Individuals With Parkinson Disease and Freezing of Gait: A Double-Blind, Randomized Controlled Trial. Arch Phys Med Rehabil. 2018;99(12):2420-2429.
Galli M, Vicidomini C, Rozin Kleiner AF, et al. Peripheral neurostimulation breaks the shuffling steps patterns in Parkinsonian gait: A double blind randomized longitudinal study with automated mechanical peripheral stimulation. Eur J Phys Rehabil Med. 2018;54(6):860-865.
Zamunér AR, Shiffer D, Barbic F, et al. Mechanical somatosensory stimulation decreases blood pressure in patients with Parkinson’s disease. J Hypertens. 2019;37(8):1714-1721

Duration of AMPS treatment effects

An important consideration for the effectiveness of GONDOLA^® AMPS treatment is how long the improvements gained from treatment last, which can guide treatment frequency recommendations. This question was addressed with a clinical study of 18 PD patients who were followed longitudinally after a series of six AMPS treatments over three weeks. Results showed that walking improvements were apparent after just one AMPS treatment, but further improvement was observed after several treatments over multiple weeks.

Furthermore, benefits were still present up to 10 days after the final AMPS treatments. These data give evidence that PD patients can gain continued improvement after several GONDOLA^® AMPS treatments and that treatments should be repeated frequently to maintain lasting improvements.

Stocchi F, Sale P, Kleiner AFR, et al. Long-term effects of automated mechanical peripheral stimulation on gait patterns of patients with Parkinson’s disease. Int J Rehabil Res. 2015;38(3):238-245.

Cardiovascular modulation benefits with AMPS treatments

As PD causes degeneration in portions of the brain responsible for autonomic cardiovascular regulation, 10-40% of PD patients experience orthostatic hypotension, or the sudden decrease in blood pressure upon standing. Nearly 50% of PD patients also experience supine hypertension, or increased blood pressure when lying down.

Therefore, in two studies of 32 PD patients, the associations between AMPS treatment and cardiovascular autonomic and hydrodynamic changes were tested. Here it was found that five AMPS treatments over two weeks significantly reduced resting blood pressure and improved the cardiovascular system’s ability to react and maintain constant blood pressure. Furthermore, improvements in the autonomic regulation of blood pressure response to postural changes (standing) was improved after a single AMPS treatment.

Therefore, in addition to improving movement symptoms, the AMPS treatment may be useful in relieving common PD-related cardiovascular issues.

Barbic F, Galli M, Vecchia LD, et al. Effects of mechanical stimulation of the feet on gait and cardiovascular autonomic control in Parkinson’s disease. J Appl Physiol. 2014;116(5):495-503.
Zamunér AR, Shiffer D, Barbic F, et al. Mechanical somatosensory stimulation decreases blood pressure in patients with Parkinson’s disease. J Hypertens. 2019;37(8):1714-1721.

AMPS treatment affects connectivity in the brain

In order to understand better how the AMPS treatment induces changes in walking ability and autonomic modulation in PD patients, researchers employed functional magnetic resonance imaging (fMRI) to detect immediate changes in connectivity in specific areas of the brain before versus after a single AMPS treatment. In the 11 studied patients, clinical measures improved after AMPS treatment, with significant decreases in both the overall Unified Parkinson’s Disease Rating motor scale (UPDR III) and the Postural Instability Gait Disturbances (PIGD) subscale. These improvements were not seen after sham AMPS treatment (placebo).

Furthermore, the administration of an effective AMPS treatment caused greater increases in connectivity than the sham AMPS treatments in the following areas of the brain: between the nucleus striatum (in the basal ganglia) and the lateral occipital cortex, cuneal cortex, and the anterior temporal cortex; between the cerebellum and the lateral occipital cortex and cerebellar cortex. These areas of increased connectivity are related to body positioning anticipation during movement along with sensory-motor and visuo-spatial processing and integration. Therefore, this study shows that brain activities may be modulated by the external stimulation provided by the GONDOLA^® medical device and could give insights into the underlying mechanisms engaged in the AMPS treatment.

Furthermore, the observed concurrent improvements in abilities to initiate lower limb movements suggest that AMPS may be useful for PD rehabilitation protocols by enabling brain connectivity pathways to manage PD symptoms such as akinesia.

Quattrocchi CC, De Pandis MF, Piervincenzi C, et al. Acute modulation of brain connectivity in Parkinson disease after automatic mechanical peripheral stimulation: A pilot study. PLoS One. 2015;10(10):1-19.

Changes in blood biomarkers in response to AMPS treatments

In addition to affecting walking abilities and general mobility, PD is often accompanied by a reduction in an important neuro-protective protein, the Brain-Derived Neurotrohpic Factor (BDNF). BDNF is a critical neurotrophin that aids in developing and maintaining synaptic plasticity, neuronal connectivity, and neuron survival, and it is especially important in the context of PD as it helps protect dopaminergic neurons from degeneration and cell death.

Because BDNF is able to cross the blood-brain barrier, its concentration in the blood can serve as a surrogate measure of levels within the brain, constituting an indirect measure of neuroplasticity. Furthermore, PD patients also typically present with an increase in the stress hormone cortisol, which can further suppress the production and release of BDNF. Therefore, it is of interest to reduce cortisol and increase BDNF blood concentrations in order to protect neural health and function in PD patients.

In a study of 33 PD patients presenting with freezing of gait (FOG) symptoms in the OFF-medication status, the effects of AMPS treatment, as administered with the Gondola device, on blood serum BDNF and cortisol levels was tested. In this study, PD patients were randomized to receive either effective or sham AMPS treatments every fourth day for four weeks.

The patients receiving effective AMPS treatments had a significantly larger increase in BDNF levels and decrease in cortisol levels compared to the group receiving sham AMPS treatments. Additionally, patients experienced greater improvements in walking abilities (increased velocity and stride length) with effective AMPS treatments versus sham AMPS treatments.

Overall, these results indicate that AMPS treatments induce a systemic biological effect and can provide a complementary gait rehabilitation therapy for PD patients that also supports neural survival, growth, and plasticity.

Pagnussat AS, Kleiner AFR, Rieder CRM, et al. Plantar stimulation in parkinsonians: From biomarkers to mobility – Randomized-controlled trial. Restor Neurol Neurosci. 2018;36(2):195-205.