Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and STN-DBS
- Conditions
- Parkinson DiseaseGait Disorders, Neurologic
- Interventions
- Device: GONDOLA AMPS
- Registration Number
- NCT04831879
- Lead Sponsor
- Gondola Medical Technologies SA
- 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 Parkinson Disease and STN-DBS (Subthalamic Nucleus Deep Brain Stimulation) in a randomized, double-blind, sham-controlled, cross-over trial
- 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 treatment phase will be 4 weeks of treatment, separated by a 6-week washout period.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group A AMPS - sham GONDOLA AMPS Treatment phase 1: AMPS Treatment phase 2: sham Group B sham - AMPS GONDOLA AMPS Treatment phase 1: sham Treatment phase 2: AMPS
- Primary Outcome Measures
Name Time Method Freezing of gait assessment course 4 weeks The primary outcome is the change in FOG severity measured by the freezing of gait assessment course (FOG-AC) and evaluated by a blinded observer using video recordings (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment).
Min: 0 Max: 36 Higher score indicates worse symptoms.
- Secondary Outcome Measures
Name Time Method Freezing of Gait Questionnaire 4 weeks FOG-Q (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment).
Min: 0 Max: 24 Higher score indicates worse symptoms.Movement Disorder Society - Unified Parkinson's Disease Rating Scale part I-IV 4 weeks MDS-UPDRS I-IV (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment).
Minimum score for all sections is 0, with higher scores indicating worse symptoms. Maximum value per section:
I: 44 II: 52 III: 108 IV: 24Parkinson's Disease Questionnaire 4 weeks PDQ-39 (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment) Min: 0 Max: 100 Higher score indicates worse symptoms.
Clinical Global Impression Severity and Improvement Scores 4 weeks CGI-S and CGI-I (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment).
Min per scale: 1 Max per scale: 7 With higher score indicating worse symptoms.Timed up and go test 4 weeks TUG (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment).
Min: 16 Max: 64 Higher score indicates worse symptoms.Falls Efficacy Scale - International 4 weeks FES-I (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment)
Fast 360° turns 4 weeks Detection of freezing of gait in patients with Parkinson's disease (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment)
30-meter walk 4 weeks Assessment to measure walking speed, functional mobility, gait, and vestibular function. (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment)
Trial Locations
- Locations (1)
Uniklinik Köln
🇩🇪Köln, North Rhine-Westphalia, Germany