Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-01-19 @ 4:24 PM
Study NCT ID:
NCT06490861
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance of the Paragit Sleeve to Measure and Monitor Motor Symptoms in Patients With 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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2024-07-01', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tremor', 'timeFrame': 'During the clinical assessment, and for the following 24h.', 'description': 'Tremor will be assessed using the device, measured with superficial EMG \\[Volts\\], and inertial measurement unit \\[m/s2\\]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.'}, {'measure': 'Bradykinesia', 'timeFrame': 'During the clinical assessment, and for the following 24h.', 'description': 'Bradykinesia will be assessed using the device, measured inertial measurement unit \\[m/s2\\]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.'}, {'measure': 'Rigidity', 'timeFrame': 'During the clinical assessment, and for the following 24h.', 'description': 'The device will assess rigidity, measured with superficial EMG \\[Volts\\], and inertial measurement unit \\[m/s2\\]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.'}, {'measure': 'Dyskinesia', 'timeFrame': 'During the clinical assessment, and for the following 24h.', 'description': 'The device will assess rigidity, measured with superficial EMG \\[Volts\\], and inertial measurement unit \\[m/s2\\]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'During the clinical assessment , and for the following 24h.', 'description': 'Safety of the Paragit Sleeve by assessment of device deficiencies and adverse events, non-serious and serious, rated for causality.'}, {'measure': 'Usability', 'timeFrame': 'During the clinical assessment , and for the following 24h.', 'description': 'The usability of the device will be studied using a questionnaire.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "This investigation is undertaken to:\n\n* Evaluate the accuracy and reliability of the device in measuring and recording motor symptoms associated with Parkinson's Disease (PD), and\n* To assess the safety and tolerability of the device in patients with PD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Parkinson disease: Clinically diagnosed\n2. Age ≥ 50 (not in the childbearing aged as defined by Statistics Denmark, 15-49)\n3. Experiencing at least two of following symptoms and/or side effect on a daily basis:\n\n * Rigidity\n * Tremor\n * Bradykinesia\n * Dyskinesia (treatment side effect)\n4. Provision of informed consent, i.e., the subject must be able to:\n\n * Read and understand the Patient Information and Consent Form\n * Sign the Patient Information and Consent Form.\n\nExclusion Criteria:\n\n1. Known allergy/hypersensitivity to any material in direct contact with the skin (stainless steel, silicone and polyester)\n2. MMSE \\<24\n3. Other neurological diseases'}, 'identificationModule': {'nctId': 'NCT06490861', 'acronym': 'PARPIV23', 'briefTitle': "Performance of the Paragit Sleeve to Measure and Monitor Motor Symptoms in Patients With Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Paragit ApS'}, 'officialTitle': "An Open Multi-centre Investigation to Evaluate the Performance of the Paragit Sleeve With build-in sEMG Sensors, Kinetic Sensors, and Smart-textile to Measure and Monitor Motor Symptoms and Treatment-induced Dyskinesia in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'PARPIV23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paragit', 'description': 'Sleeve to quantify symptoms', 'interventionNames': ['Device: Paragit']}], 'interventions': [{'name': 'Paragit', 'type': 'DEVICE', 'description': 'Sleeve to quantify symptoms', 'armGroupLabels': ['Paragit']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Pablo Romero, PhD', 'role': 'CONTACT', 'email': 'p.romero.prof@ufv.es', 'phone': '+34'}], 'facility': 'Hospital Beata María Ana', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paragit ApS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}