Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-01-05 @ 2:04 PM
Study NCT ID:
NCT03104803
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2017-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-23', 'studyFirstSubmitDate': '2017-04-01', 'studyFirstSubmitQcDate': '2017-04-01', 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Daniels and Worthingham's Muscle Testing", 'timeFrame': '2 days after the last stimulation session', 'description': 'each hand muscle is evaluated on 0-5 scale'}, {'measure': "Daniels and Worthingham's Muscle Testing", 'timeFrame': '1 month after the last stimulation session', 'description': 'each hand muscle is evaluated on 0-5 scale'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Diseases', 'Spinal Cord Injuries']}, 'referencesModule': {'references': [{'pmid': '31886442', 'type': 'RESULT', 'citation': 'Tolmacheva A, Savolainen S, Kirveskari E, Brandstack N, Makela JP, Shulga A. Paired associative stimulation improves hand function after non-traumatic spinal cord injury: A case series. Clin Neurophysiol Pract. 2019 Aug 13;4:178-183. doi: 10.1016/j.cnp.2019.07.002. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The investigators have recently shown in incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles (1). In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete SCI of non-traumatic origin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* incomplete SCI of non-traumatic origin\n\nExclusion Criteria:\n\n* epilepsy\n* metal inclusion in the head area\n* pacemaker\n* hearing device\n* high intracranial pressure'}, 'identificationModule': {'nctId': 'NCT03104803', 'briefTitle': 'Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin', 'orgStudyIdInfo': {'id': 'ULD 8100014-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long-term PAS', 'description': 'The intervention is given to one hand only', 'interventionNames': ['Device: long-term paired associative stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Contralateral hand of the same patient'}], 'interventions': [{'name': 'long-term paired associative stimulation', 'type': 'DEVICE', 'description': 'Paired associative stimulation (PAS) administered several times per week for 6 weeks to one hand. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).', 'armGroupLabels': ['Long-term PAS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'BioMag laboratory', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Validia Rehabilitation Center', 'class': 'UNKNOWN'}, {'name': 'University of Helsinki', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Anastasia Shulga', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}