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Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease

This study is not yet open for participant recruitment.
Verified July 2017 by Gianni Pezzoli, ASST Gaetano Pini-CTO
Sponsor:
ClinicalTrials.gov Identifier:
NCT03211260
First Posted: July 7, 2017
Last Update Posted: July 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Fondazione Grigioni per il Morbo di Parkinson
Policlinico San Matteo Pavia Fondazione IRCCS
Information provided by (Responsible Party):
Gianni Pezzoli, ASST Gaetano Pini-CTO
  Purpose
Freezing of gait (FOG) is a common disabling condition in Parkinson's disease (PD), causes falls, and impairs quality of life. Therapeutic options for this symptom are limited and of limited efficacy. Besides, the pathophysiology has been not clarified yet. Proprioceptive sensitivity is likely to play a role and recent studies have reported that high-frequency microfocal vibratory stimulation exert a modulatory effect of proprioceptive reflex circuits and could be considered a valuable treatment strategy. However, evidence is not available. The present study was designed to collect preliminary evidence of efficacy of a vibrotactile device (Equistasi) for the treatment of FOG.

Condition Intervention
Freezing of Gait Parkinson Disease Device: EQUISTASI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease: a Open, Single-arm Trial

Resource links provided by NLM:


Further study details as provided by Gianni Pezzoli, ASST Gaetano Pini-CTO:

Primary Outcome Measures:
  • Freezing of gait questionnaire severity [ Time Frame: 4 weeks ]
    Change in freezing of gait questionnaire score


Secondary Outcome Measures:
  • Gait and Falls Questionnaire (GFQ) score [ Time Frame: 4 weeks ]
    Change in the GFQ score

  • Quality of life [ Time Frame: 4 weeks ]
    Change in quality of life measured using the 39-item Parkinson's Disease Questionnaire

  • Falls [ Time Frame: 4 weeks ]
    Number of falls recorded during the intervention period

  • Treatment continuation [ Time Frame: 4 weeks ]
    Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale


Estimated Enrollment: 64
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EQUISTASI
Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.
Device: EQUISTASI
Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with Parkinson's Disease
  • Stable drug therapy response without any change in the 3 months before the study.
  • written informed consent

Exclusion Criteria:

  • Hoehn-Yahr stage ≥ 4
  • Cognitive decline (Mini Mental State Examination <26)
  • Systemic illness involving the nervous system
  • Diabetes
  • Presence of cardiac pacemaker
  • Presence of deep brain stimulation
  • Presence of severe dysautonomia with marked hypotension
  • History or active neoplasia
  • Pregnancy
  Contacts and Locations
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): NCT03211260


Contacts
Contact: Gianni Pezzoli, MD +390257993222 gianni.pezzoli@gmail.com
Contact: Emanuele Cereda, MD, PhD +390382501484 e.cereda@smatteo.pv.it

Locations
Italy
Centro Parkinson, ASST Gaetano Pini-CTO Not yet recruiting
Milano, Italy
Contact: Gianni Pezzoli, MD    +390257993222    gianni.pezzoli@gmail.com   
Sponsors and Collaborators
ASST Gaetano Pini-CTO
Fondazione Grigioni per il Morbo di Parkinson
Policlinico San Matteo Pavia Fondazione IRCCS
Investigators
Principal Investigator: Gianni Pezzoli, MD Centro Parkinson, ASST Gaetano Pini-CTO di Milano
  More Information

Responsible Party: Gianni Pezzoli, Principal Investigator, ASST Gaetano Pini-CTO
ClinicalTrials.gov Identifier: NCT03211260     History of Changes
Other Study ID Numbers: 319_2017bis
First Submitted: July 2, 2017
First Posted: July 7, 2017
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gianni Pezzoli, ASST Gaetano Pini-CTO:
Parkinson Disease
Freezing of gait
Equistasi

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases