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AMBITION: A clinical study focusing on “Freezing of Gait” (FOG)

The AMBITION clinical trial aims to investigate the safety and efficacy of the Gondola AMPS therapy in 40 Parkinson’s disease patients suffering from severe Freezing of Gait (FOG) symptoms, despite dopaminergic and deep brain stimulation (DBS) treatments. It is a particularly interesting population to use the Gondola AMPS therapy, as there are limited treatment options for FOG treatment.

The study is designed as a prospective, randomized, double-blind, sham-controlled, cross-over trial. As such, participants will use the Gondola® Home Device with two different configurations for two treatment periods of four weeks each, with a randomized configuration order per participant.

A Gondola® Medical Device will be provided to the participants to use during the treatment periods. As with the commercially available device, each participant will have personalized insoles fabricated, based on 3D scans of their feet, and inserted into the device. During the treatment periods, participants will conduct the Gondola AMPS therapy three times per week at home.

AMBITION looking for effects on freezing
Our research collaborators at the Cologne University Hospital in Germany will assess the treatment effects at the end of each treatment period using walking tests, questionnaires, and clinical rating scales. Between the two treatment periods, there will be a period of at least six weeks in which participants will not receive AMPS therapy through the Gondola® Medical Device. This ensures that the effects of one treatment configuration do not carry over into the subsequent treatment period. Additionally, throughout the entire study duration, the participants will keep their other therapies consistent, including medications, DBS parameters, and any physical or ergo therapies. Like this, any observed changes in outcome measures can be directly attributed to the Gondola AMPS therapies.

From the study results, we expect to see a significant reduction in the number of FOG episodes experienced by the participants along with improved walking speed, walking performance, functional balance, and quality of life measures after one month’s use of the Gondola® Therapeutic Device. Given the low-risk nature of the Gondola AMPS therapy, we do not expect to observe any safety events during the study. Together, these outcomes would indicate that PD patients with FOG symptoms have an opportunity for increased mobility and independence with Gondola AMPS therapy without side effects.

An ethics committee has approved all study procedures in accordance with Good Clinical Practices, and details of the study protocol are registered and available to the public at ClinicalTrials.gov