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

NCT04831879 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-04-15

No results posted yet for this study

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

Conditions

  • Parkinson Disease
  • Gait Disorders, Neurologic

Interventions

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

Sponsors & Collaborators

  • University of Cologne

    collaborator OTHER

  • Gondola Medical Technologies SA

    lead INDUSTRY

Principal Investigators

  • Michael Barbe, MD · Department of Neurology, University Hospital Cologne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2022-04-27
Completion
2022-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04831879 on ClinicalTrials.gov