Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-01-01 @ 1:07 AM
Study NCT ID:
NCT05842434
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2023-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's Tremor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020329', 'term': 'Essential Tremor'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'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': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2023-04-24', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Performance Subscale', 'timeFrame': 'Baseline to 7 days', 'description': 'A subset of 6 performance tasks will be rated by a physician for each upper limb separately. Each task will be rated from 0 to 4, indicating the increasing severity of tremor.'}, {'measure': "Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)", 'timeFrame': 'Baseline to 7 days', 'description': 'Physician rated MDS-UPDRS Part III on a 5-point scale, from 0 (normal) to 4 (severe)'}, {'measure': 'Clinical Global Impression of Severity (CGI-S)', 'timeFrame': 'Baseline to 7 days', 'description': 'Physician rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)'}, {'measure': 'Clinical Global Impression of Improvement (CGI-I)', 'timeFrame': 'Baseline to 7 days', 'description': 'Physician rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)'}, {'measure': 'Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Activities of Daily Living (ADL) Subscale', 'timeFrame': 'Baseline to 7 days', 'description': 'Patient rating on a 5-point scale, from 0 (normal) to 4 (severely abnormal)'}, {'measure': 'Patient Global Impression of Severity (PGI-S)', 'timeFrame': 'Baseline to 7 days', 'description': 'Patient rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)'}, {'measure': 'Patient Global Impression of Improvement (PGI-I)', 'timeFrame': 'Baseline to 7 days', 'description': 'Patient rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)'}, {'measure': 'Tremor Power', 'timeFrame': 'Baseline to 7 days', 'description': 'Assessed by device sensor.'}, {'measure': 'Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Modified Activities of Daily Living (mADL) Subscale', 'timeFrame': 'Baselinen to 7 days', 'description': 'TETRAS mADL score is a composite sum of items 2 to 11 of the TETRAS ADL subscale and items 6 (bilateral) and 7 (dominant hand) of the TETRAS performance subscale (PS). TETRAS mADL score is calculated as the sum of all 12 items and ranges from 0 to 52.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Essential Tremor', 'Parkinson Disease']}, 'descriptionModule': {'briefSummary': "A prospective, open-label, multi-center pilot study designed to evaluate the safety and effectiveness of the Felix system in the relief of upper limb tremors in adults with essential tremor and Parkinson's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Willing to provide written, informed consent to participate in the study.\n3. For subjects with essential tremor (ET):\n\n 1. A clinical diagnosis of ET.\n 2. For either upper limb, a tremor severity score of 2 or higher as measured by one of the TETRAS items and a total score of 6 or higher across all TETRAS tasks.\n4. For subjects with Parkinson's disease (PD):\n\n 1. A clinical diagnosis of PD (MDS-PD criteria).\n 2. A tremor score of 2 or higher on MDS-UPDRS question 3.15 (postural tremor) or 3.16 (kinetic tremor), OR\n 3. A rest tremor score of 2 or higher on MDS-UPDRS question 3.17 (rest tremor amplitude) in one upper extremity and a score of 2 or higher on MDS-UPDRS question 3.18 (constancy of tremor).\n5. Stable dosage of any medication, if applicable, for 30 days prior to study entry.\n6. Familiar with operating a touch-screen smartphone and connecting to Wi-Fi internet at home.\n7. If necessary, have a dedicated caregiver to help with study required activities, such as putting on the study device, etc.\n8. Willing to comply with study protocol requirements including:\n\n 1. Remaining on a stable dosage of current medications, if applicable, during the course of the study.\n 2. Remaining on stable caffeine consumption, if applicable, during the course of t the study.\n 3. No alcohol consumption on the day before a study visit.\n\nExclusion Criteria:\n\n1. Prior limb amputation or any known symptomatic peripheral neuropathy condition of the involved upper extremity.\n2. Any current drug or alcohol abuse.\n3. Current unstable epileptic conditions with a seizure within 6 months of study entry.\n4. Pregnant or nursing subjects and those who plan pregnancy during the course of the study.\n5. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at the stimulation site.\n6. Known allergy to adhesives.\n7. History of Alzheimer's disease or dementia (Montreal Cognitive Assessment (MoCA)≤19).\n8. Botulinum Toxin injection for hand tremor within 4 months prior to study enrollment.\n9. Subject is currently participating or has participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor.\n10. Subject is unable to communicate with the investigator and staff.\n11. Any health condition that in the investigator's opinion should preclude participation in this study."}, 'identificationModule': {'nctId': 'NCT05842434', 'briefTitle': "Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's Tremor", 'organization': {'class': 'INDUSTRY', 'fullName': 'Fasikl Inc.'}, 'officialTitle': "Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's Tremor", 'orgStudyIdInfo': {'id': 'CIP-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Felix', 'interventionNames': ['Device: Felix']}], 'interventions': [{'name': 'Felix', 'type': 'DEVICE', 'description': "Felix is a wrist-worn, noninvasive, transcutaneous neurostimulation system intended for daily use to suppress hand tremors. An artificial intelligence (AI) algorithm will automatically adjust the stimulation based on each patient's tremor throughout the day.", 'armGroupLabels': ['Felix']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': "Parkinson's Disease and Movement Disorders Center of Boca Raton", 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Richard B Dewey III, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Parkinson's Disease and Movement Disorders Center of Boca Raton"}, {'name': 'Rajesh Pahwa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fasikl Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}