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

ASST Gaetano Pini-CTO

Status: Terminated

Conditions: Freezing of Gait; Parkinson Disease

Treatments: Device: EQUISTASI

Study type: Interventional

Funder types: Other

Identifiers

NCT03211260

319_2017bis

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

EQUISTASI

Experimental group

Description:

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

Treatment:

Device: EQUISTASI