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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Freezing of gait assessment course

Timeframe: 4 weeks

Trial details

NCT IDNCT04831879

SponsorGondola Medical Technologies SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-27

Contact for this trial

Michael Barbe, MD

0221 478 7494 michael.barbe@uk-koeln.de

View on ClinicalTrials.gov More Parkinson Disease trials