Status:
UNKNOWN
Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and STN-DBS
Lead Sponsor:
Gondola Medical Technologies SA
Collaborating Sponsors:
University of Cologne
Conditions:
Parkinson Disease
Gait Disorders, Neurologic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Previous enrolment into the current study,
- Pregnancy
- Enrolment of the investigator, his/her family members, employees and other dependent persons,
- L-Dopa induced-freezing (defined by medical history),
- DBS-induced freezing (defined by medical history),
- Clinically relevant depression
- Clinically relevant cognitive impairments
- Shoe size greater than 46
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04831879
Start Date
March 25 2021
End Date
June 30 2022
Last Update
April 15 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Uniklinik Köln
Cologne, North Rhine-Westphalia, Germany, 50937