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

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ClinicalTrials.gov Identifier: NCT03211260
Recruitment Status : Terminated (Iterim analysis did not detect a clinically meaningful change in the primary endpoint)
First Posted : July 7, 2017
Last Update Posted : September 12, 2019
Sponsor:
Collaborators:
Grisons Foundation for Parkinson's Disease
Policlinico San Matteo Pavia Fondazione IRCCS
Information provided by (Responsible Party):
Gianni Pezzoli, ASST Gaetano Pini-CTO

Tracking Information
First Submitted Date  ICMJE July 2, 2017
First Posted Date  ICMJE July 7, 2017
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE December 11, 2017
Actual Primary Completion Date July 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
Freezing of gait questionnaire severity [ Time Frame: 4 weeks ]
Change in freezing of gait questionnaire score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
  • Gait and Falls Questionnaire (GFQ) score [ Time Frame: 4 weeks ]
    Change in the GFQ score
  • 39-item Parkinson's Disease Questionnaire [ 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease
Official Title  ICMJE Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease: a Open, Single-arm Trial
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Freezing of Gait
  • Parkinson Disease
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: EQUISTASI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 10, 2019)
42
Original Estimated Enrollment  ICMJE
 (submitted: July 6, 2017)
64
Actual Study Completion Date  ICMJE July 19, 2019
Actual Primary Completion Date July 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03211260
Other Study ID Numbers  ICMJE 319_2017bis
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gianni Pezzoli, ASST Gaetano Pini-CTO
Study Sponsor  ICMJE ASST Gaetano Pini-CTO
Collaborators  ICMJE
  • Grisons Foundation for Parkinson's Disease
  • Policlinico San Matteo Pavia Fondazione IRCCS
Investigators  ICMJE
Principal Investigator: Gianni Pezzoli, MD Centro Parkinson, ASST Gaetano Pini-CTO di Milano
PRS Account ASST Gaetano Pini-CTO
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP