Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-08 @ 9:54 AM
Study NCT ID:
NCT03211260
Status:
TERMINATED
Last Update Posted:
2019-09-12
First Post:
2017-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'whyStopped': 'Iterim analysis did not detect a clinically meaningful change in the primary endpoint', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2017-07-02', 'studyFirstSubmitQcDate': '2017-07-06', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freezing of gait questionnaire severity', 'timeFrame': '4 weeks', 'description': 'Change in freezing of gait questionnaire score'}], 'secondaryOutcomes': [{'measure': 'Gait and Falls Questionnaire (GFQ) score', 'timeFrame': '4 weeks', 'description': 'Change in the GFQ score'}, {'measure': "39-item Parkinson's Disease Questionnaire", 'timeFrame': '4 weeks', 'description': "Change in quality of life measured using the 39-item Parkinson's Disease Questionnaire"}, {'measure': 'Falls', 'timeFrame': '4 weeks', 'description': 'Number of falls recorded during the intervention period'}, {'measure': 'Treatment continuation', 'timeFrame': '4 weeks', 'description': 'Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson Disease', 'Freezing of gait', 'Equistasi'], 'conditions': ['Freezing of Gait', 'Parkinson Disease']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient with Parkinson's Disease\n* Stable drug therapy response without any change in the 3 months before the study.\n* written informed consent\n\nExclusion Criteria:\n\n* Hoehn-Yahr stage ≥ 4\n* Cognitive decline (Mini Mental State Examination \\<26)\n* Systemic illness involving the nervous system\n* Diabetes\n* Presence of cardiac pacemaker\n* Presence of deep brain stimulation\n* Presence of severe dysautonomia with marked hypotension\n* History or active neoplasia\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT03211260', 'briefTitle': "Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'ASST Gaetano Pini-CTO'}, 'officialTitle': "Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease: a Open, Single-arm Trial", 'orgStudyIdInfo': {'id': '319_2017bis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EQUISTASI', 'description': 'Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.', 'interventionNames': ['Device: EQUISTASI']}], 'interventions': [{'name': 'EQUISTASI', 'type': 'DEVICE', 'description': 'Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.', 'armGroupLabels': ['EQUISTASI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'Centro Parkinson, ASST Gaetano Pini-CTO', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Gianni Pezzoli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Parkinson, ASST Gaetano Pini-CTO di Milano'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ASST Gaetano Pini-CTO', 'class': 'OTHER'}, 'collaborators': [{'name': "Grisons Foundation for Parkinson's Disease", 'class': 'OTHER'}, {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gianni Pezzoli', 'investigatorAffiliation': 'ASST Gaetano Pini-CTO'}}}}