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

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ClinicalTrials.gov Identifier: NCT04831879
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : April 15, 2021
Sponsor:
Collaborator:
University of Cologne
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Parkinson Disease Gait Disorders, Neurologic Device: GONDOLA AMPS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized sham-controlled cross-over trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 25, 2021
Estimated Primary Completion Date : April 27, 2022
Estimated Study Completion Date : June 30, 2022


Arm Intervention/treatment
Experimental: Group A AMPS - sham
Treatment phase 1: AMPS Treatment phase 2: sham
Device: GONDOLA 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

Experimental: Group B sham - AMPS
Treatment phase 1: sham Treatment phase 2: AMPS
Device: GONDOLA 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




Primary Outcome Measures :
  1. Freezing of gait assessment course [ Time Frame: 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 :
  1. Freezing of Gait Questionnaire [ Time Frame: 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.


  2. Timed up and go test [ Time Frame: 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.


  3. Movement Disorder Society - Unified Parkinson's Disease Rating Scale part I-IV [ Time Frame: 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


  4. Parkinson's Disease Questionnaire [ Time Frame: 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.

  5. Clinical Global Impression Severity and Improvement Scores [ Time Frame: 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.


  6. Falls Efficacy Scale - International [ Time Frame: 4 weeks ]
    FES-I (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment)

  7. Fast 360° turns [ Time Frame: 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)

  8. 30-meter walk [ Time Frame: 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)


Other Outcome Measures:
  1. Parkinson Neuropsychometric Dementia Assessment [ Time Frame: 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.

  2. Beck's Depression Inventory [ Time Frame: 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.

  3. Levodopa equivalent daily dose [ Time Frame: Throughout the duration of study, approximately 26 weeks ]
    LEDD

  4. Deep Brain Stimulation - Total Electrical Energy Delivered [ Time Frame: Throughout the duration of study, approximately 26 weeks ]
    DBS TEED



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04831879


Contacts
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Contact: Michael Barbe, MD 0221 478 7494 michael.barbe@uk-koeln.de

Locations
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Germany
Uniklinik Köln Recruiting
Köln, North Rhine-Westphalia, Germany, 50937
Contact: Elfriede Stubbs    +49 221 478 98842    elfriede.stubbs@uk-koeln.de   
Principal Investigator: Michael Barbe, Dr         
Sponsors and Collaborators
Gondola Medical Technologies SA
University of Cologne
Investigators
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Principal Investigator: Michael Barbe, MD Department of Neurology, University Hospital Cologne
Additional Information:
Publications:

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Responsible Party: Gondola Medical Technologies SA
ClinicalTrials.gov Identifier: NCT04831879    
Other Study ID Numbers: UKK - AMBITION
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gondola Medical Technologies SA:
Freezing Of Gait
FOG
Deep Brain Stimulation
Parkinson Disease
Additional relevant MeSH terms:
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Parkinson Disease
Nervous System Diseases
Gait Disorders, Neurologic
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations