Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and STN-DBS

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Parkinson Disease, Gait Disorders, Neurologic

Intervention / Treatment
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* Device: GONDOLA AMPS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized sham-controlled cross-over trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A AMPS - sham<br>Treatment phase 1: AMPS Treatment phase 2: sham | Device: GONDOLA AMPS<br>* The Gondola device is composed of two units, one per foot, each having two motors that activate rounded stimulation tips that interact with the target points. It delivers mechanical, pressure-based stimulations, sequentially in each of the four points, for the duration of 6 seconds per point. This treatment cycle is repeated 4 times, for an overall treatment duration of less than 2 minutes<br>|
| Experimental: Group B sham - AMPS<br>Treatment phase 1: sham Treatment phase 2: AMPS | Device: GONDOLA AMPS<br>* The Gondola device is composed of two units, one per foot, each having two motors that activate rounded stimulation tips that interact with the target points. It delivers mechanical, pressure-based stimulations, sequentially in each of the four points, for the duration of 6 seconds per point. This treatment cycle is repeated 4 times, for an overall treatment duration of less than 2 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freezing of gait assessment course | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freezing of Gait Questionnaire | 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. | 4 weeks | 
| Timed up and go test | 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. | 4 weeks | 
| Movement Disorder Society - Unified Parkinson's Disease Rating Scale part I-IV | 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: 24 | 4 weeks | 
| Parkinson's Disease Questionnaire | 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. | 4 weeks | 
| Clinical Global Impression Severity and Improvement Scores | 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. | 4 weeks | 
| Falls Efficacy Scale - International | FES-I (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment) | 4 weeks | 
| Fast 360° turns | 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) | 4 weeks | 
| 30-meter walk | 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) | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Freezing Of Gait, FOG, Deep Brain Stimulation, Parkinson Disease