Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 9:54 AM
Study NCT ID:
NCT04372134
Status:
COMPLETED
Last Update Posted:
2020-05-01
First Post:
2020-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of rTMS in Patients With Spinal Cord Injury (rTMS:Repetetive Transcranial Magnetic Stimulation)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-30', 'studyFirstSubmitDate': '2020-04-08', 'studyFirstSubmitQcDate': '2020-04-30', 'lastUpdatePostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The lower extremity motor scores of the patients', 'timeFrame': 'through study completion, an average of 2 weeks (Change from Baseline The lower extremity motor scores of the patients at 2 weeks.)', 'description': 'The lower extremity motor scores of the patients (degree of muscle strength according to the American Spinal Injury Association (ASIA) Impairment Scale )(The assesment of ASIA scale includes 5 classification as ASIA A, B,C,D,E. ASIA A is the worst score and ASIA E is the best score)'}], 'secondaryOutcomes': [{'measure': 'the parameters of gait analysis - walking speed', 'timeFrame': 'through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)', 'description': 'walking speed (centimeter/second) obtained in the motion analysis laboratory'}, {'measure': 'the parameters of gait analysis - cadence', 'timeFrame': 'through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)', 'description': 'cadence (number of steps/minute) obtained in the motion analysis laboratory'}, {'measure': 'the parameters of gait analysis - single support time', 'timeFrame': 'through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)', 'description': 'single support time (second) obtained in the motion analysis laboratory'}, {'measure': 'the parameters of gait analysis - double support time', 'timeFrame': 'through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)', 'description': 'double support time (second) obtained in the motion analysis laboratory'}, {'measure': 'the parameters of gait analysis - contralateral foot contact time', 'timeFrame': 'through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)', 'description': 'contralateral foot contact time (second) obtained in the motion analysis laboratory'}, {'measure': 'the parameters of gait analysis - step time', 'timeFrame': 'through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)', 'description': 'step time (second) obtained in the motion analysis laboratory'}, {'measure': 'the parameters of gait analysis - step speed', 'timeFrame': 'through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)', 'description': 'step speed (centimeter/second)) obtained in the motion analysis laboratory'}, {'measure': 'Walking Index for SCI - II (WISCI-II) Scale', 'timeFrame': 'through study completion, an average of 2 weeks (Change from Baseline WISCI II scale scores of the patients at 2 weeks.)', 'description': 'Walking Index for SCI - II (WISCI-II) Scale (WISCI -II is a scale to assess the amount of physical assistance needed as well as device reuired for walking ( The development of this assessment index required a rank ordering along a dimension of impairment, from the level of most severe impairment (0) to least severe impairment (20) based on the use of devices, braces and physical assistance of one or more persons. The order of the levels suggests each successive level is a less impaired level than the former)'}, {'measure': '10-meter Gait Test', 'timeFrame': 'through study completion, an average of 2 weeks (Change from Baseline 10 meter gait test scores of the patients at 2 weeks.)', 'description': '10-meter Gait Test (This test is used to assess walking speed in meters per second over a short duration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['r TMS', 'spinal cord injury', 'motor recovery,', 'gait'], 'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'It is postulated that high frequency repetitive transcranial magnetic stimulation (rTMS) can decrease the corticospinal inhibition and enhance the motor recovery. This study is aimed to investigate the effect of high frequency rTMS on lower extremity motor recovery and gait parameters in patients with chronic motor incomplete traumatic spinal cord injury (SCI).', 'detailedDescription': 'A sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (\\>1 year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance. Lower extremity motor score (LEMS), the temporal-spatial gait parameters measured by 3D gait analysis, Walking Index for SCI-II (WISCI-II) scale and 10 meters walking test were assessed at baseline, 3 weeks (after the treatment sessions) and 5 weeks (follow-up).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the diagnosis of motor incomplete cervical or thoracic spinal cord injury (ASIA C or D), spinal cord injury due to trauma at least one year previously\n* the ability to walk at least 10 meters independently or with assisted devices such as cane / canadian, age (18-45 years). All participants signed the informed consent form.\n\nExclusion Criteria:\n\n* the presence of other musculoskeletal or neurological diseases that may prevent walking, lower motor neuron lesion (cauda equina and conus medullaris)\n* family history of epilepsy\n* the presence of brain injury\n* the presence of cranium defect\n* the presence of pacemaker\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT04372134', 'acronym': 'rTMS:', 'briefTitle': 'The Effect of rTMS in Patients With Spinal Cord Injury (rTMS:Repetetive Transcranial Magnetic Stimulation)', 'organization': {'class': 'OTHER', 'fullName': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital'}, 'officialTitle': 'The Effect of High Frequency Repetetive Transcranial Magnetic Stimulation on Motor Recovery and Gait Parameters in Patients With Chronic Incomplete Spinal Cord Injury', 'orgStudyIdInfo': {'id': '3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'real rTMS group', 'description': 'motor incomplete traumatic SCI patients receiving real repetitive transcranial magnetic stimulation therapy', 'interventionNames': ['Device: repetitive transcranial magnetic stimulation therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham r TMS', 'description': 'motor incomplete traumatic SCI patients receiving sham repetitive transcranial magnetic stimulation therapy', 'interventionNames': ['Device: repetitive transcranial magnetic stimulation therapy']}], 'interventions': [{'name': 'repetitive transcranial magnetic stimulation therapy', 'type': 'DEVICE', 'otherNames': ['rehabilitation program'], 'description': 'A sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (\\>1 year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance.', 'armGroupLabels': ['real rTMS group', 'sham r TMS']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'SERDAR KESİKBURUN, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Scientific and Technological Research Council of Turkey'}, {'name': 'AYÇA URAN ŞAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Scientific and Technological Research Council of Turkey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical Medicine and Rehabilitation Specialist', 'investigatorFullName': 'Yasin Demir', 'investigatorAffiliation': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital'}}}}