NCT04831879

Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and STN-DBS

Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and Subthalamic Nucleus Deep Brain Stimulation (STN-DBS) - a Randomized Double-blind, Sham Controlled, Cross-over Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Gondola Medical Technologies SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective is to investigate whether AMPS (Automated Mechanical Peripheral Stimulation) is effective in reduction of FOG measured via the FOG-AC (Freezing Of Gait Assessment Course) in people with Parkinson Disease and STN-DBS (Subthalamic Nucleus Deep Brain Stimulation) in a randomized, double-blind, sham-controlled, cross-over trial

Detailed description

The effects of AMPS treatment (effective vs sham) will be measured using the FOG-AC assessment. Patients will be randomized to receive either AMPS treatment and then sham or sham and then AMPS. Each treatment phase will be 4 weeks of treatment, separated by a 6-week washout period.

Conditions

• Parkinson Disease
• Gait Disorders, Neurologic

Interventions

Type	Name	Description
DEVICE	GONDOLA AMPS	The Gondola device is composed of two units, one per foot, each having two motors that activate rounded stimulation tips that interact with the target points. It delivers mechanical, pressure-based stimulations, sequentially in each of the four points, for the duration of 6 seconds per point. This treatment cycle is repeated 4 times, for an overall treatment duration of less than 2 minutes

Timeline

• Start date: 2021-03-25
• Primary completion: 2022-04-27
• Completion: 2022-06-30
• First posted: 2021-04-05
• Last updated: 2021-04-15

Locations

1 site across 1 country: Germany