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Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease
This study is not yet open for participant recruitment.
Verified July 2017 by Gianni Pezzoli, ASST Gaetano Pini-CTO
Sponsor:
ASST Gaetano Pini-CTO
Collaborators:
Fondazione Grigioni per il Morbo di Parkinson
Policlinico San Matteo Pavia Fondazione IRCCS
Information provided by (Responsible Party):
Gianni Pezzoli, ASST Gaetano Pini-CTO
ClinicalTrials.gov Identifier:
NCT03211260
First received: July 2, 2017
Last updated: July 6, 2017
Last verified: July 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| Freezing of Gait Parkinson Disease | Device: EQUISTASI |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease: a Open, Single-arm Trial |
Resource links provided by NLM:
Genetics Home Reference related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
U.S. FDA Resources
Further study details as provided by Gianni Pezzoli, ASST Gaetano Pini-CTO:
Primary Outcome Measures:
- Freezing of gait questionnaire severity [ Time Frame: 4 weeks ]Change in freezing of gait questionnaire score
Secondary Outcome Measures:
- Gait and Falls Questionnaire (GFQ) score [ Time Frame: 4 weeks ]Change in the GFQ score
- Quality of life [ Time Frame: 4 weeks ]Change in quality of life measured using the 39-item Parkinson's Disease Questionnaire
- Falls [ Time Frame: 4 weeks ]Number of falls recorded during the intervention period
- Treatment continuation [ Time Frame: 4 weeks ]Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale
| Estimated Enrollment: | 64 |
| Anticipated Study Start Date: | September 2017 |
| Estimated Study Completion Date: | October 2018 |
| Estimated Primary Completion Date: | September 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211260
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211260
Contacts
| Contact: Gianni Pezzoli, MD | +390257993222 | gianni.pezzoli@gmail.com | |
| Contact: Emanuele Cereda, MD, PhD | +390382501484 | e.cereda@smatteo.pv.it |
Locations
| Italy | |
| Centro Parkinson, ASST Gaetano Pini-CTO | Not yet recruiting |
| Milano, Italy | |
| Contact: Gianni Pezzoli, MD +390257993222 gianni.pezzoli@gmail.com | |
Sponsors and Collaborators
ASST Gaetano Pini-CTO
Fondazione Grigioni per il Morbo di Parkinson
Policlinico San Matteo Pavia Fondazione IRCCS
Investigators
| Principal Investigator: | Gianni Pezzoli, MD | Centro Parkinson, ASST Gaetano Pini-CTO di Milano |
More Information
| Responsible Party: | Gianni Pezzoli, Principal Investigator, ASST Gaetano Pini-CTO |
| ClinicalTrials.gov Identifier: | NCT03211260 History of Changes |
| Other Study ID Numbers: |
319_2017bis |
| Study First Received: | July 2, 2017 |
| Last Updated: | July 6, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Gianni Pezzoli, ASST Gaetano Pini-CTO:
|
Parkinson Disease Freezing of gait Equistasi |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on July 11, 2017