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

NCT03211260 | Terminated

• 1 other identifier: 319_2017bis
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Freezing of Gait; Parkinson Disease

Keywords

Parkinson Disease; Freezing of gait; Equistasi

Outcome Measures

Primary Outcomes (1)

• Freezing of gait questionnaire severity

  Change in freezing of gait questionnaire score

  4 weeks

Secondary Outcomes (4)

• Gait and Falls Questionnaire (GFQ) score

  4 weeks

• 39-item Parkinson's Disease Questionnaire

  4 weeks

• Falls

  4 weeks

• Treatment continuation

  4 weeks

Study Arms (1)

EQUISTASI

EXPERIMENTAL

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

Interventions

EQUISTASI DEVICE

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

EQUISTASI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• ASST Gaetano Pini-CTO: lead
• Grisons Foundation for Parkinson's Disease: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator

Study Sites (1)

Centro Parkinson, ASST Gaetano Pini-CTO

Milan, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Gianni Pezzoli, MD

  Centro Parkinson, ASST Gaetano Pini-CTO di Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2017
• First Posted: July 7, 2017
• Study Start: December 11, 2017
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

IT (1)