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

Primary Purpose

Freezing of Gait, Parkinson Disease

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EQUISTASI
Sponsored by
ASST Gaetano Pini-CTO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Freezing of Gait focused on measuring Parkinson Disease, Freezing of gait, Equistasi

Eligibility Criteria

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

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

Sites / Locations

  • Centro Parkinson, ASST Gaetano Pini-CTO

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EQUISTASI

Arm Description

Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.

Outcomes

Primary Outcome Measures

Freezing of gait questionnaire severity
Change in freezing of gait questionnaire score

Secondary Outcome Measures

Gait and Falls Questionnaire (GFQ) score
Change in the GFQ score
39-item Parkinson's Disease Questionnaire
Change in quality of life measured using the 39-item Parkinson's Disease Questionnaire
Falls
Number of falls recorded during the intervention period
Treatment continuation
Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale

Full Information

First Posted
July 2, 2017
Last Updated
September 10, 2019
Sponsor
ASST Gaetano Pini-CTO
Collaborators
Grisons Foundation for Parkinson's Disease, Fondazione IRCCS Policlinico San Matteo di Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT03211260
Brief Title
Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease
Official Title
Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease: a Open, Single-arm Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Iterim analysis did not detect a clinically meaningful change in the primary endpoint
Study Start Date
December 11, 2017 (Actual)
Primary Completion Date
July 19, 2019 (Actual)
Study Completion Date
July 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ASST Gaetano Pini-CTO
Collaborators
Grisons Foundation for Parkinson's Disease, Fondazione IRCCS Policlinico San Matteo di Pavia

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Freezing of Gait, Parkinson Disease
Keywords
Parkinson Disease, Freezing of gait, Equistasi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EQUISTASI
Arm Type
Experimental
Arm Description
Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.
Intervention Type
Device
Intervention Name(s)
EQUISTASI
Intervention Description
Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.
Primary Outcome Measure Information:
Title
Freezing of gait questionnaire severity
Description
Change in freezing of gait questionnaire score
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Gait and Falls Questionnaire (GFQ) score
Description
Change in the GFQ score
Time Frame
4 weeks
Title
39-item Parkinson's Disease Questionnaire
Description
Change in quality of life measured using the 39-item Parkinson's Disease Questionnaire
Time Frame
4 weeks
Title
Falls
Description
Number of falls recorded during the intervention period
Time Frame
4 weeks
Title
Treatment continuation
Description
Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale
Time Frame
4 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianni Pezzoli, MD
Organizational Affiliation
Centro Parkinson, ASST Gaetano Pini-CTO di Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Parkinson, ASST Gaetano Pini-CTO
City
Milano
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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