Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson'… (NCT04831879) | Clinical Trial Compass
UnknownNot Applicable
Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and STN-DBS
Germany40 participantsStarted 2021-03-25
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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