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

Primary Purpose

Parkinson Disease, Gait Disorders, Neurologic

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
GONDOLA AMPS
Sponsored by
Gondola Medical Technologies SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Freezing Of Gait, FOG, Deep Brain Stimulation, Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uniklinik KölnRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A AMPS - sham

Group B sham - AMPS

Arm Description

Treatment phase 1: AMPS Treatment phase 2: sham

Treatment phase 1: sham Treatment phase 2: AMPS

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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.
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.
Falls Efficacy Scale - International
FES-I (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment)
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)
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)

Full Information

First Posted
March 25, 2021
Last Updated
April 14, 2021
Sponsor
Gondola Medical Technologies SA
Collaborators
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT04831879
Brief Title
Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and STN-DBS
Acronym
AMBITION
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
April 27, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gondola Medical Technologies SA
Collaborators
University of Cologne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Gait Disorders, Neurologic
Keywords
Freezing Of Gait, FOG, Deep Brain Stimulation, Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized sham-controlled cross-over trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A AMPS - sham
Arm Type
Experimental
Arm Description
Treatment phase 1: AMPS Treatment phase 2: sham
Arm Title
Group B sham - AMPS
Arm Type
Experimental
Arm Description
Treatment phase 1: sham Treatment phase 2: AMPS
Intervention Type
Device
Intervention Name(s)
GONDOLA AMPS
Intervention Description
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 Measure Information:
Title
Freezing of gait assessment course
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Freezing of Gait Questionnaire
Description
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.
Time Frame
4 weeks
Title
Timed up and go test
Description
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.
Time Frame
4 weeks
Title
Movement Disorder Society - Unified Parkinson's Disease Rating Scale part I-IV
Description
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
Time Frame
4 weeks
Title
Parkinson's Disease Questionnaire
Description
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.
Time Frame
4 weeks
Title
Clinical Global Impression Severity and Improvement Scores
Description
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.
Time Frame
4 weeks
Title
Falls Efficacy Scale - International
Description
FES-I (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment)
Time Frame
4 weeks
Title
Fast 360° turns
Description
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)
Time Frame
4 weeks
Title
30-meter walk
Description
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)
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Parkinson Neuropsychometric Dementia Assessment
Description
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.
Time Frame
Duration of study, from screening to last follow-up visit, approximately 26 weeks
Title
Beck's Depression Inventory
Description
BDI Min per scale: 0 Max per scale: 63 With higher score indicating worse symptoms.
Time Frame
Duration of study, from screening to last follow-up visit, approximately 26 weeks
Title
Levodopa equivalent daily dose
Description
LEDD
Time Frame
Throughout the duration of study, approximately 26 weeks
Title
Deep Brain Stimulation - Total Electrical Energy Delivered
Description
DBS TEED
Time Frame
Throughout the duration of study, approximately 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Barbe, MD
Phone
0221 478 7494
Email
michael.barbe@uk-koeln.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Barbe, MD
Organizational Affiliation
Department of Neurology, University Hospital Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniklinik Köln
City
Köln
State/Province
North Rhine-Westphalia
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elfriede Stubbs
Phone
+49 221 478 98842
Email
elfriede.stubbs@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Michael Barbe, Dr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan
Citations:
PubMed Identifier
26164797
Citation
Stocchi F, Sale P, Kleiner AF, Casali M, Cimolin V, de Pandis F, Albertini G, Galli M. Long-term effects of automated mechanical peripheral stimulation on gait patterns of patients with Parkinson's disease. Int J Rehabil Res. 2015 Sep;38(3):238-45. doi: 10.1097/MRR.0000000000000120.
Results Reference
background
PubMed Identifier
26469868
Citation
Quattrocchi CC, de Pandis MF, Piervincenzi C, Galli M, Melgari JM, Salomone G, Sale P, Mallio CA, Carducci F, Stocchi F. Acute Modulation of Brain Connectivity in Parkinson Disease after Automatic Mechanical Peripheral Stimulation: A Pilot Study. PLoS One. 2015 Oct 15;10(10):e0137977. doi: 10.1371/journal.pone.0137977. eCollection 2015.
Results Reference
background
PubMed Identifier
30663967
Citation
Prusch JS, Kleiner AFR, Salazar AP, Pinto C, Marchese RR, Galli M, Pagnussat AS. Automated mechanical peripheral stimulation and postural control in subjects with Parkinson's disease and freezing of gait: a randomized controlled trial. Funct Neurol. 2018 Oct/Dec;33(4):206-212.
Results Reference
background
PubMed Identifier
29309313
Citation
Pinto C, Pagnussat AS, Rozin Kleiner AF, Marchese RR, Salazar AP, Rieder CRM, Galli M. Automated Mechanical Peripheral Stimulation Improves Gait Parameters in Subjects With Parkinson Disease and Freezing of Gait: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2018 Jun;97(6):383-389. doi: 10.1097/PHM.0000000000000890.
Results Reference
background
PubMed Identifier
32299120
Citation
Pagnussat AS, Salazar AP, Pinto C, Redivo Marchese R, Rieder CRM, Alves Filho JO, Franco AR, Kleiner AFR. Plantar stimulation alters brain connectivity in idiopathic Parkinson's disease. Acta Neurol Scand. 2020 Sep;142(3):229-238. doi: 10.1111/ane.13253. Epub 2020 May 5.
Results Reference
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PubMed Identifier
29526852
Citation
Pagnussat AS, Kleiner AFR, Rieder CRM, Frantz A, Ehlers J, Pinto C, Dorneles G, Netto CA, Peres A, Galli M. Plantar stimulation in parkinsonians: From biomarkers to mobility - randomized-controlled trial. Restor Neurol Neurosci. 2018;36(2):195-205. doi: 10.3233/RNN-170744.
Results Reference
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PubMed Identifier
29902470
Citation
Kleiner AFR, Souza Pagnussat A, Pinto C, Redivo Marchese R, Salazar AP, Galli M. Automated Mechanical Peripheral Stimulation Effects on Gait Variability in Individuals With Parkinson Disease and Freezing of Gait: A Double-Blind, Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Dec;99(12):2420-2429. doi: 10.1016/j.apmr.2018.05.009. Epub 2018 Jun 11.
Results Reference
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PubMed Identifier
26495152
Citation
Kleiner A, Galli M, Gaglione M, Hildebrand D, Sale P, Albertini G, Stocchi F, De Pandis MF. The Parkinsonian Gait Spatiotemporal Parameters Quantified by a Single Inertial Sensor before and after Automated Mechanical Peripheral Stimulation Treatment. Parkinsons Dis. 2015;2015:390512. doi: 10.1155/2015/390512. Epub 2015 Oct 1.
Results Reference
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PubMed Identifier
29457707
Citation
Galli M, Vicidomini C, Rozin Kleiner AF, Vacca L, Cimolin V, Condoluci C, Stocchi F, De Pandis MF. Peripheral neurostimulation breaks the shuffling steps patterns in Parkinsonian gait: a double blind randomized longitudinal study with automated mechanical peripheral stimulation. Eur J Phys Rehabil Med. 2018 Dec;54(6):860-865. doi: 10.23736/S1973-9087.18.05037-2. Epub 2018 Feb 19.
Results Reference
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PubMed Identifier
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Citation
Barbic F, Galli M, Dalla Vecchia L, Canesi M, Cimolin V, Porta A, Bari V, Cerri G, Dipaola F, Bassani T, Cozzolino D, Pezzoli G, Furlan R. Effects of mechanical stimulation of the feet on gait and cardiovascular autonomic control in Parkinson's disease. J Appl Physiol (1985). 2014 Mar 1;116(5):495-503. doi: 10.1152/japplphysiol.01160.2013. Epub 2014 Jan 16.
Results Reference
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PubMed Identifier
31107357
Citation
Zamuner AR, Shiffer D, Barbic F, Minonzio M, Andrade CP, Corato M, Lalli S, Dipaola F, Cairo B, Albanese A, Porta A, Furlan R. Mechanical somatosensory stimulation decreases blood pressure in patients with Parkinson's disease. J Hypertens. 2019 Aug;37(8):1714-1721. doi: 10.1097/HJH.0000000000002084.
Results Reference
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Links:
URL
https://www.gondola-medical.com/
Description
Sponsor website

Learn more about this trial

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

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