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

Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease: a Open, Single-arm Trial

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease; Freezing of Gait
• Intervention / Treatment: Device: EQUISTASI

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy
    • Centro Parkinson, ASST Gaetano Pini-CTO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freezing of gait questionnaire severity	Change in freezing of gait questionnaire score	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment continuation	Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale	4 weeks
Gait and Falls Questionnaire (GFQ) score	Change in the GFQ score	4 weeks
39-item Parkinson's Disease Questionnaire	Change in quality of life measured using the 39-item Parkinson's Disease Questionnaire	4 weeks
Falls	Number of falls recorded during the intervention period	4 weeks

Collaborators and Investigators

• Sponsor: ASST Gaetano Pini-CTO
• Collaborators: Fondazione IRCCS Policlinico San Matteo di Pavia; Grisons Foundation for Parkinson's Disease
• Investigators: Principal Investigator: Gianni Pezzoli, MD, Centro Parkinson, ASST Gaetano Pini-CTO di Milano

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2017
• Primary Completion (Actual): July 19, 2019
• Study Completion (Actual): July 19, 2019

Study Registration Dates

• First Submitted: July 2, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Parkinson Disease; Freezing of gait; Equistasi
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 319_2017bis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No