Gait Disorders, Neurologic, Parkinson Disease
Conditions
Keywords
Freezing Of Gait, FOG, Deep Brain Stimulation, Parkinson Disease
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.
Interventions
DEVICEGONDOLA AMPS
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
Sponsors
University of Cologne
Gondola Medical Technologies SA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized sham-controlled cross-over trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Parkinson'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. |
| 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) |
| 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. |
| 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. |
| 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: 24 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Levodopa equivalent daily dose | Throughout the duration of study, approximately 26 weeks | LEDD |
| Deep Brain Stimulation - Total Electrical Energy Delivered | Throughout the duration of study, approximately 26 weeks | DBS TEED |
| Parkinson Neuropsychometric Dementia Assessment | Duration of study, from screening to last follow-up visit, approximately 26 weeks | PANDA Minimum value is 0, and the maximal raw scores of the subtests are associate learning immediate: 12, fluency: no maximum, working memory: 6, spatial imagery: 3, associate learning delayed: 4. Higher score indicate lesser symptoms. |
| Beck's Depression Inventory | Duration of study, from screening to last follow-up visit, approximately 26 weeks | BDI Min per scale: 0 Max per scale: 63 With higher score indicating worse symptoms. |
Countries
Germany
Contacts
Primary ContactMichael Barbe, MD
Outcome results
None listed