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: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Informed Consent as documented by signature (Appendix Informed Consent Form)

• ≥18 years old

• Diagnosis of Parkinson's Disease according to the United Kingdom Brain Bank Criteria

• Bilateral STN-DBS for at least 6 months

• Moderate to severe FOG i.e. FOG-AC ≥8 pts.

Locations
Other Locations
Germany
Uniklinik Köln
Recruiting
Köln
Contact Information
Primary
Michael Barbe, MD
michael.barbe@uk-koeln.de
0221 478 7494
Time Frame
Start Date: March 25, 2021
Estimated Completion Date: June 30, 2022
Participants
Target number of participants: 40
Treatments
Experimental: Group A AMPS - sham
Treatment phase 1: AMPS Treatment phase 2: sham
Experimental: Group B sham - AMPS
Treatment phase 1: sham Treatment phase 2: AMPS
Sponsors
Leads: Gondola Medical Technologies SA
Collaborators: University of Cologne

This content was sourced from clinicaltrials.gov

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