Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-20 @ 11:49 PM
Study NCT ID:
NCT02635893
Status:
COMPLETED
Last Update Posted:
2021-07-01
First Post:
2015-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Limb Function After Spinal Cord Injury
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': 'D003523', 'term': 'Cycloserine'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D012694', 'term': 'Serine'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-29', 'studyFirstSubmitDate': '2015-12-11', 'studyFirstSubmitQcDate': '2015-12-16', 'lastUpdatePostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in motor evoked potential size', 'timeFrame': '30 minutes before and 30 minutes after intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SCI'], 'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'This is a randomized, experimental study that examines the physiology of central nervous system pathways contributing to the control of bilateral movements in individuals with spinal cord injuries and promotes the recovery of lower-limb motor function through the use of stimulation and locomotor training.', 'detailedDescription': 'This study plans to examine plasticity in corticospinal synapses of lower-limb muscles. it has been demonstrated that plasticity elicited at corticospinal synapses in the spinal cord result in enhancements in electromyographic (EMG) and force activity in upper-limb muscles. The first step in this proposal is to determine if synaptic plasticity can be elicited in corticospinal projections targeting lower-limb muscles in humans with SCI.\n\nWe will also study methods to strengthen corticospinal plasticity to promote recovery of leg clearance during training. We will use two novel strategies to enhance plasticity in corticospinal synapses of lower-limb muscles after SCI: a). administration of an N-methyl-D-aspartate (NMDA) receptor agonist (i.e. D-cycloserine), and b). Combine NMDA-induced corticospinal plasticity with training (2D lower limb training and locomotor training. Corticospinal synaptic plasticity is thought to depend on activation of NMDA receptors and D-cycloserine enhances motor skill behaviors in animals and humans will be enhanced by NMDA-induced corticospinal plasticity. An important strength of this aim is the combination of training and strategies that aimed at enhancing the synaptic efficacy of residual corticospinal projections. Training effects on physiological pathways will be explored and correlated with locomotor function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 4\\. Inclusion criteria for individuals with SCI:\n\n * Male and females between ages 18-85 years of age\n * SCI ( ≥1 month of injury)\n * ASIA A, B,C and D\n * SCI above L5\n * Able to perform a visible contraction with dorsiflexor and hip flexor muscles (allowing testing of largely impaired patients)\n * Able to ambulate a few steps with or without an assistive device\n\nInclusion criteria for healthy controls:\n\n* Male and females between ages 18-85 years of age\n* Able to walk and complete lower-limb tests with both legs\n\nExclusion Criteria:\n\nExclusion criteria for individuals with SCI\n\n* Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease,\n* Any debilitating disease prior to the SCI that caused exercise intolerance\n* Premorbid, ongoing major depression or psychosis, altered cognitive status\n* History of head injury or stroke,\n* Metal plate in skull\n* History of seizures\n* Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants.\n* Pregnant females, and\n* Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida or herniated cervical disk.\n\nExclusion criteria for healthy controls:\n\n* Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease,\n* Any debilitating disease that causes exercise intolerance\n* Premorbid, ongoing major depression or psychosis, altered cognitive status\n* History of head injury or stroke,\n* Metal plate in skull\n* History of seizures\n* Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants.\n* Pregnant females, and\n* Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida or herniated cervical disk.'}, 'identificationModule': {'nctId': 'NCT02635893', 'briefTitle': 'Lower Limb Function After Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Shirley Ryan AbilityLab'}, 'officialTitle': 'Lower Limb Function After Spinal Cord Injury', 'orgStudyIdInfo': {'id': '20150605'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'D-Cycloserine/Placebo + Stimulation', 'description': 'Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation.', 'interventionNames': ['Drug: D-Cycloserine', 'Drug: Placebo', 'Other: Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Training+Med/Placebo+Stimulation', 'description': 'Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation followed by training.', 'interventionNames': ['Drug: D-Cycloserine', 'Drug: Placebo', 'Other: Training', 'Other: Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Training+Med+Stimulation/Placebo Stim', 'description': 'Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation or placebo stimulation followed by training.', 'interventionNames': ['Drug: D-Cycloserine', 'Other: Training', 'Other: Stimulation', 'Other: Placebo Stimulation']}], 'interventions': [{'name': 'D-Cycloserine', 'type': 'DRUG', 'otherNames': ['Seromycin'], 'description': '100 mg of Seromycin by mouth will be administered', 'armGroupLabels': ['D-Cycloserine/Placebo + Stimulation', 'Training+Med+Stimulation/Placebo Stim', 'Training+Med/Placebo+Stimulation']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo Drug'], 'description': 'placebo pill will be administered instead of medication by mouth', 'armGroupLabels': ['D-Cycloserine/Placebo + Stimulation', 'Training+Med/Placebo+Stimulation']}, {'name': 'Training', 'type': 'OTHER', 'description': 'walking around a designated track at different speeds both forward and backward', 'armGroupLabels': ['Training+Med+Stimulation/Placebo Stim', 'Training+Med/Placebo+Stimulation']}, {'name': 'Stimulation', 'type': 'OTHER', 'description': 'magnetic stimulation and electrical stimulation may be applied', 'armGroupLabels': ['D-Cycloserine/Placebo + Stimulation', 'Training+Med+Stimulation/Placebo Stim', 'Training+Med/Placebo+Stimulation']}, {'name': 'Placebo Stimulation', 'type': 'OTHER', 'description': 'this is a fake stimulation that is administered but will be unknow to the subject.', 'armGroupLabels': ['Training+Med+Stimulation/Placebo Stim']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The Shirley Ryan Ability Lab', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Monica A Perez, PT, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shirley Ryan AbilityLab'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Craig H. Neilsen Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair Arms + Hands Lab', 'investigatorFullName': 'Monica Perez', 'investigatorAffiliation': 'Shirley Ryan AbilityLab'}}}}