AMBITION: a clinical study focusing on “Freezing the March”

The AMBITION clinical trial aims to investigate the safety and efficacy of Gondola AMPS therapy. Forty patients with Parkinson's disease who suffer from severe episodes of March Freezing, despite already following dopaminergic and deep brain stimulation (DBS) treatments, will participate in the study. This is a particularly interesting population to test Gondola AMPS therapy, since there are not many treatments for Freezing.

The study was designed as a prospective, randomized, double-blind, placebo-stimulation-controlled, cross-over study. Therefore, participants will use the Gondola device^® for home use with two different configurations (effective and placebo) for two treatment periods, four weeks each. The configuration of the first period, effective or placebo, will be random for each participant.

Participants will be provided with a Gondola medical device^® to be used during the two treatment periods. As with the device currently on the market, each participant will have customized insoles produced based on 3-D scans of their feet and inserted into the device. During the two treatment periods, participants will conduct Gondola AMPS therapy three times a week at home.

Our research collaborators at the University Hospital of Cologne in Germany will evaluate treatment effects at the end of each treatment period using walk tests, questionnaires and clinical rating scales. Between the two treatment periods, there will be a period of at least six weeks when participants will not receive AMPS therapy via the Gondola Medical Device^®. This ensures that the effects of one treatment configuration will not carry over to the next treatment period. In addition, throughout the duration of the study, participants will hold their other therapies constant, including medications, DBS parameters, and any physical or occupational therapy. In this way, any observed changes in outcome measures can be directly attributed to the Gondola AMPS therapies.

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

An ethics committee approved all study procedures in accordance with Good Clinical Practice, and details of the study protocol are recorded and publicly available at ClinicalTrials.gov.