Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-26 @ 2:28 PM
Study NCT ID:
NCT04882592
Status:
UNKNOWN
Last Update Posted:
2023-04-04
First Post:
2021-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stepping overground or on a treadmill', 'timeFrame': '3 months'}, {'measure': 'Gross Motor Functional Measure (GMFM)', 'timeFrame': '3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '36198701', 'type': 'DERIVED', 'citation': 'Hastings S, Zhong H, Feinstein R, Zelczer G, Mitrovich C, Gad P, Edgerton VR. A pilot study combining noninvasive spinal neuromodulation and activity-based neurorehabilitation therapy in children with cerebral palsy. Nat Commun. 2022 Oct 5;13(1):5660. doi: 10.1038/s41467-022-33208-w.'}]}, 'descriptionModule': {'briefSummary': 'Assessing the effects of noninvasive spinal cord neuromodulation on improving function in individuals with cerebral palsy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) individuals above the age of 2 years of age and 2) diagnosed with cerebral palsy (CP). The exclusion criteria included 1) children with selective dorsal root rhizotomy, 2) intramuscular Botox injection in the preceding 12 months, 3) current antispastic medications 4) unhealed fractures or contractures that would prevent them from performing functional tasks and 5) tendon lengthening surgeries.\n\nExclusion Criteria:\n\n* Intramuscular Botox injection in the past 12 months'}, 'identificationModule': {'nctId': 'NCT04882592', 'briefTitle': 'Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'SpineX Inc.'}, 'officialTitle': 'Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'SPNX-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic Arm', 'description': 'Spinal Cord Neuromodulation with SCiP during Activity Based NeuroRehab Therapy', 'interventionNames': ['Device: SCiP']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Arm', 'description': 'Sham Stimulation during Activity Based NeuroRehab Therapy', 'interventionNames': ['Device: SCiP']}], 'interventions': [{'name': 'SCiP', 'type': 'DEVICE', 'description': 'Noninvasive spinal cord neuromodulator', 'armGroupLabels': ['Sham Arm', 'Therapeutic Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90064', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Parag Gad, PhD', 'role': 'CONTACT', 'email': 'parag@spinex.co', 'phone': '408-203-5061'}], 'facility': 'SpineX', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Parag Gad, PhD', 'role': 'CONTACT', 'email': 'parag@spinex.co', 'phone': '4082035061'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SpineX Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}