Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
Study NCT ID:
NCT03886857
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2019-03-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Segmental Mechanisms of Transcutaneous Spinal Cord Stimulation for Spasticity Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-09', 'studyFirstSubmitDate': '2019-03-18', 'studyFirstSubmitQcDate': '2019-03-21', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postsynaptic inhibition', 'timeFrame': 'pre-intervention to 2 hours post-intervention', 'description': 'reciprocal inhibition of the soleus H-reflex'}], 'secondaryOutcomes': [{'measure': 'Presynaptic inhibition', 'timeFrame': 'pre-intervention to 2 hours post-intervention', 'description': 'induced D1 inhibition and ongoing presynaptic inhibition of the soleus-H reflex'}, {'measure': 'H_max/M_max', 'timeFrame': 'pre-intervention to 2 hours post-intervention', 'description': 'Ratio of the maximum H reflex and the maximum M wave'}, {'measure': 'Low-frequency depression', 'timeFrame': 'pre-intervention to 2 hours post-intervention', 'description': 'rate-dependent depression of the soleus H-reflex'}, {'measure': 'Evaluation of lower-limb spasticity', 'timeFrame': 'pre-intervention to 2 hours post-intervention', 'description': 'surface-electromyography based assessments'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'The aim of the pilot study is to gain first insights into the interaction of transcutaneous spinal cord stimulation with the altered activity of intraspinal circuits associated with spinal spasticity. The main goal is to evaluate the validity of the chosen measures and to generate a data base for statistical planning of a subsequent clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nwritten informed consent prior to participation\n\nfor participants with intact CNS:\n\n• no previous neurological or musculoskeletal disorders\n\nfor participants with spinal cord injury:\n\n* Spinal cord injury due to trauma\n* ≥ 12 months post-spinal cord injury\n* complete or incomplete spinal cord injury classified as grade C or D on the American Spinal Injury Association Impairment Scale (AIS)\n* neurological level of spinal cord injury: C3-T10\n* preserved tendon and cutaneo-muscular reflexes in the lower limbs\n\nExclusion Criteria:\n\n* other neuromuscular diseases, e.g., amyotrophic lateral sclerosis (ALS), Parkinson's disease, Guillain-Barré syndrome, muscular dystrophy\n* active implants (e.g., cardiac pacemaker, drug pump)\n* passive implants at vertebral level T10 or caudal (e.g., metal screws/plates for surgical stabilization of spinal fractures)\n* active infections or diseases, pressure sores\n* dermatological issues at the stimulation site\n* malignant diseases\n* heart insufficiency (NYHA III-IV)\n* potential pregnancy (pregnancy test to be conducted in women of child bearing age before application of transcutaneous spinal cord stimulation)"}, 'identificationModule': {'nctId': 'NCT03886857', 'acronym': 'SCS_CorE_AT', 'briefTitle': 'Segmental Mechanisms of Transcutaneous Spinal Cord Stimulation for Spasticity Control', 'organization': {'class': 'OTHER', 'fullName': 'Klinikum Floridsdorf'}, 'officialTitle': 'Carry-over Effects of Transcutaneous Spinal Cord Stimulation for Spasticity Control on Inhibitory Circuits of the Spinal Cord: a Pilot Study', 'orgStudyIdInfo': {'id': 'SCS-CorE_AT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'transcutaneous spinal cord stimulation', 'type': 'DEVICE', 'description': 'noninvasive electrical stimulation of the human lumbar spinal cord'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1210', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Klinik Floridsdorf', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Ursula Hofstoetter, Prof., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter Lackner', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of Vienna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Peter Lackner', 'investigatorAffiliation': 'Klinikum Floridsdorf'}}}}