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

NCT03211260 — Not applicable, Terminated, 42 participants, ASST Gaetano Pini-CTO

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

Registry	NCT03211260
Status	Terminated - Iterim analysis did not detect a clinically meaningful change in the primary endpoint
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	42 (Actual)
Sponsor	ASST Gaetano Pini-CTO (Other); collaborators: Grisons Foundation for Parkinson's Disease, Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions	Freezing of Gait, Parkinson Disease
Interventions	EQUISTASI (Device)
Dates	start 2017-12-11, primary completion 2019-07-19, completion 2019-07-19, first posted 2017-07-07, last updated 2019-09-12
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
EQUISTASI	Experimental	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.

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.

+Outcome measures

Primary outcomes

Freezing of gait questionnaire severity [4 weeks]: Change in freezing of gait questionnaire score

Secondary outcomes

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

+Eligibility

Sex: All

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

+Locations (1)

Facility	City	Country	Status
Centro Parkinson, ASST Gaetano Pini-CTO	Milan	Italy

+Investigators

Gianni Pezzoli, MD, Principal investigator, Centro Parkinson, ASST Gaetano Pini-CTO di Milano