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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03211260
• Other study ID #: 319_2017bis
• Status: Terminated
• Phase: N/A
• Start date: December 11, 2017
• Est. completion date: July 19, 2019

Study information

• Verified date: September 2019
• Source: ASST Gaetano Pini-CTO
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: July 19, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Freezing of Gait
• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Italy	Centro Parkinson, ASST Gaetano Pini-CTO	Milano

Sponsors (3)

Lead Sponsor	Collaborator
ASST Gaetano Pini-CTO	Grisons Foundation for Parkinson's Disease, Policlinico San Matteo Pavia Fondazione IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freezing of gait questionnaire severity	Change in freezing of gait questionnaire score	4 weeks
Secondary	Gait and Falls Questionnaire (GFQ) score	Change in the GFQ score	4 weeks
Secondary	39-item Parkinson's Disease Questionnaire	Change in quality of life measured using the 39-item Parkinson's Disease Questionnaire	4 weeks
Secondary	Falls	Number of falls recorded during the intervention period	4 weeks
Secondary	Treatment continuation	Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale	4 weeks