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

NCT04831879 | Unknown DMC

• 1 other identifier: UKK - AMBITION
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Keywords

Freezing Of Gait; FOG; Deep Brain Stimulation; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Freezing of Gait Questionnaire

  4 weeks

• Timed up and go test

  4 weeks

• Movement Disorder Society - Unified Parkinson's Disease Rating Scale part I-IV

  4 weeks

• Parkinson's Disease Questionnaire

  4 weeks

• Clinical Global Impression Severity and Improvement Scores

  4 weeks

Other Outcomes (4)

• Parkinson Neuropsychometric Dementia Assessment

  Duration of study, from screening to last follow-up visit, approximately 26 weeks

• Beck's Depression Inventory

  Duration of study, from screening to last follow-up visit, approximately 26 weeks

• Levodopa equivalent daily dose

  Throughout the duration of study, approximately 26 weeks

Study Arms (2)

Group A AMPS - sham

EXPERIMENTAL

Treatment phase 1: AMPS Treatment phase 2: sham

Device: GONDOLA AMPS

Group B sham - AMPS

EXPERIMENTAL

Treatment phase 1: sham Treatment phase 2: AMPS

Device: GONDOLA AMPS

Interventions

GONDOLA AMPS DEVICE

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

Group A AMPS - sham; Group B sham - AMPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gondola Medical Technologies SA: lead
• University of Cologne: collaborator

Study Sites (1)

Uniklinik Köln

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Related Publications (11)

• 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.

  PMID: 26164797 BACKGROUND

• 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.

  PMID: 26469868 BACKGROUND

• 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.

  PMID: 30663967 BACKGROUND

• 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.

  PMID: 29309313 BACKGROUND

• 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.

  PMID: 32299120 BACKGROUND

• 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.

  PMID: 29526852 BACKGROUND

• 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.

  PMID: 29902470 BACKGROUND

• 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.

  PMID: 26495152 BACKGROUND

• 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.

  PMID: 29457707 BACKGROUND

• 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.

  PMID: 24436294 BACKGROUND

• 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.

  PMID: 31107357 BACKGROUND

Related Links

• Sponsor website

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Barbe, MD

  Department of Neurology, University Hospital Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Barbe, MD

CONTACT

0221 478 7494; michael.barbe@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized sham-controlled cross-over trial

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 5, 2021
• Study Start: March 25, 2021
• Primary Completion: April 27, 2022
• Study Completion: June 30, 2022
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)