Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT03509558
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2018-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcutaneous Spinal Stimulation and Exercise for Locomotion
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': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2018-03-24', 'studyFirstSubmitQcDate': '2018-04-25', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Six-Minute Walk Test', 'timeFrame': '1-11 months', 'description': 'Measurement of walking ability. The distance is reported in meter.'}, {'measure': 'Two-minute walk test', 'timeFrame': '1-11 months', 'description': 'A measurement of endurance that assesses walking distance over two minutes.'}], 'secondaryOutcomes': [{'measure': 'International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination', 'timeFrame': '1-11 months', 'description': 'Standard neurologic examination that is routinely used to determine the levels and severity of spinal cord injury. Includes manual muscle strength testing and dermatomal light touch and pin prick sensory examination.'}, {'measure': 'Somatosensory evoked potentials', 'timeFrame': '1-11 months', 'description': 'Measurement of latency of electrical potentials that is recorded by surface electrodes over the scalp following electrical stimulation of peripheral nerve from the wrist. The latency of the response is reported in micro-seconds.'}, {'measure': 'Somatosensory evoked potentials', 'timeFrame': '1-11 months', 'description': 'Measurement of amplitude of electrical potentials that is recorded by surface electrodes over the scalp following electrical stimulation of peripheral nerve from the wrist. The amplitude of the response is reported in micro-volts.'}, {'measure': 'Motor evoked potentials', 'timeFrame': '1-11 months', 'description': 'Measurement of latency of electrical potentials that is recorded by surface electrodes over the skin of limb muscles following spinal stimulation or magnetic stimulation of brain over the scalp. The latency of the response is reported in micro-seconds.'}, {'measure': 'Motor evoked potentials', 'timeFrame': '1-11 months', 'description': 'Measurement of amplitude of electrical potentials that is recorded by surface electrodes over the skin of limb muscles following spinal stimulation or magnetic stimulation of brain over the scalp. The amplitude of the response is reported in micro-volts.'}, {'measure': 'Berg Balance Test', 'timeFrame': '1-11 months', 'description': 'Measurement of balance in standing and sitting. The balance score consists of 14 items and is reported in the scale of 56 (each items are score in 0-4).'}, {'measure': 'Ten-meter walk test', 'timeFrame': '1-11 months', 'description': 'Measurement of walking ability. The walking speed is reported in meter per second.'}, {'measure': 'Gait analysis', 'timeFrame': '1-11 months', 'description': 'Measurement of leg function and walking ability. Joint angle is reported in degree angle. Step length is reported in centimeters and swing time is reported in seconds.'}, {'measure': 'Kinetic and kinematic gait analysis using 3D camera system', 'timeFrame': '1-11 months', 'description': 'Measurement of leg function and walking ability. Velocity is reported in meter per second.'}, {'measure': 'Electromyography recording of lower extremity and trunk muscles', 'timeFrame': '1-11 months', 'description': 'Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts.'}, {'measure': 'Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire', 'timeFrame': '1-11 months', 'description': 'Patient reported quality of life scale. The SCI-QOL consists of 19 item banks, and is reported by T-score comparing the mean of the functional level in the population.'}, {'measure': 'Spinal Cord Injury - Functional Index (SCI-FI) questionnaire', 'timeFrame': '1-11 months', 'description': 'Patient reported functional scale. The SCI-QOL consists of 10 item banks, and is reported by T-score comparing the mean of the functional level in the population.'}, {'measure': 'Modified Ashworth Scale', 'timeFrame': '1-11 months', 'description': 'Measurement of spasticity. Tests resistance to passive movement about joints. Score range from 0-4, with 6 choices.'}, {'measure': 'Neurogenic Bowel Dysfunction Score', 'timeFrame': '1-11 months', 'description': "self-report questionnaire designed to help healthcare professionals evaluate the effectiveness of their patient's current bowel management routine by assessing the impact it has on the patient's quality of life.\n\nQuestions ask about background parameters (n=8), faecal incontinence (n=10), constipation (n=10), obstructed defecation (n=8), and impact on quality of life (QOL)."}, {'measure': 'Neurogenic Bladder Symptom Score', 'timeFrame': '1-11 months', 'description': 'objective and validated self-report questionnaire to assess bladder symptoms in patients with neurogenic bladder dysfunction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Spinal electrical stimulation'], 'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': "Growing evidence indicates that electrical spinal cord stimulation improves motor functions both immediately and over the long term via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated, and painless lumbosacral transcutaneous electrical stimulation strategy was demonstrated to be effective in improving lower limb motor function in participants with spinal cord injury. Our current project, cervical transcutaneous electrical stimulation and intensive exercise for arms and hands are also revealing a significant improvement in upper extremity function. Additionally, the subject and caregiver noted that stair climbing ability has been substantially enhanced starting from the first week of cervical stimulation treatment and continues to date.\n\nThis study is a prospective efficacy trial of combined transcutaneous cervical and lumbosacral electrical stimulation with physical therapy for improving locomotion in people with anatomically incomplete tetraplegia and paraplegia.\n\nThis experiment design consists of testing walking function with and without transcutaneous spinal cord stimulation. A two to four-phase intervention program will include physical therapy and spinal cord stimulation with physical therapy. The length of any intervention phase, and number of measurements performed during that phase, will be determined by multiple factors, including participants' health condition, availability, and response to intervention. Between each intervention, washout periods of up to one month may be used to determine any after-effects of the interventions.\n\nThe intervention arms will be repeated if the functional improvement does not reach a plateau during the first two months of intervention. Physical therapy will include functional training (e.g., walking training) and strength training. Each spinal cord stimulation with physical therapy intervention block can use transcutaneous lumbosacral stimulation or cervical and lumbosacral stimulation. Both immediate and lasting improvements in lower extremity function and autonomic function via transcutaneous spinal cord stimulation and intensive physical therapy may be evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has spinal cord injury (T12 or higher level) of at least 1-year duration\n* Is between 21 and 70 years of age\n* Has difficulty with leg functions and mobility in activities of daily living (e.g. walking, transferring surface to surface, standing)\n* Has stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in lower extremity rehabilitation or testing activities\n* Is capable of performing simple cued motor tasks\n* Has ability to attend up to 5 sessions per week physical therapy sessions and testing activities\n* Has adequate social support to be able to participate in training and assessment sessions, up to 5 sessions per week, for the duration of up to 11 months within the study period\n* Is volunteering to be involved in this study\n* Cleared for gait training by the primary physician of the subject\n* Has the ability to read and speak English\n\nExclusion Criteria:\n\n* Has autoimmune etiology of spinal cord dysfunction/injury\n* Has history of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc.\n* Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)\n* Has rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)\n* Has significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.\n* Has active cancer\n* Has cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention\n* Has unhealed fracture, contracture, pressure sore, urinary tract infection, or other illnesses that might interfere with lower extremity rehabilitation or testing activities\n* Has any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician\n* is pregnant\n* is dependent on ventilation support\n* Has implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc)\n* Has depression or anxiety based on the Center for Epidemiologic Studies Depression Scale (CESD) (score \\>16/60) and General Anxiety Disorder-7 item Questionnaire (score \\>9/21), respectively\n* Has alcohol and/or drug abuse\n* Has cognitive impairment based on Short Portable Mental Status Questionnaire (SPMSQ) (score \\>2/10)\n* is unable to read and/or comprehend the consent form\n* is unable to understand the instructions given as part of the study\n* Has established osteoporosis and taking medication for osteoporosis treatment\n* Has bone mineral density T scores ≤ -3.5 or Z scores ≤ -2.5 in the anteroposterior lumbar spine and/or proximal femur measured by a DEXA scan for subjects weight bearing and ambulating outside of a body-weight supporting exoskeleton (if participants are clear for other criteria and have not been examined by Dual Energy Xray Absorptiometry (DEXA) at the screening, we will ask participants to undergo DEXA to reveal any risk of weight bearing activity)\n* Has low-energy fracture history before or after spinal cord injury\n* History of orthopedic surgery in lower extremities that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, arthrodesis, etc.)\n* fixed lower extremity joint contractures\n* is taller than 80 inches and/or more than 350 pounds body weights, due to the limitation of the experimental equipment such as the body weight support system\n* lacks the ability to fully comprehend and/or perform study procedures in the investigator's opinion/judgement\n* has history of severe allergy (i.e. allergic reaction that could not be treated with antihistaminic medication)\n* has malabrosption syndrome, primary hyperthyroidism, and/or hypogonadism\n* has a history of seizures\n* has chronic headaches or migraines\n* has deep brain stimulators, metallic devices in the head such as aneurysm clips/coils and stents, vagus nerve stimulators"}, 'identificationModule': {'nctId': 'NCT03509558', 'briefTitle': 'Transcutaneous Spinal Stimulation and Exercise for Locomotion', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Transcutaneous Spinal Stimulation With Intensive Physical Therapy for Locomotion', 'orgStudyIdInfo': {'id': 'STUDY00003070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transcutaneous spinal stimulation & Physical therapy', 'description': 'Transcutaneous electrical stimulation combined with physical therapy that targets rehabilitation of walking and standing functions', 'interventionNames': ['Device: Transcutaneous spinal stimulation', 'Other: Physical Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physical therapy only', 'description': 'Physical therapy that targets rehabilitation of walking and standing functions', 'interventionNames': ['Other: Physical Therapy']}], 'interventions': [{'name': 'Transcutaneous spinal stimulation', 'type': 'DEVICE', 'otherNames': ['Physical Therapy'], 'description': 'Non-invasive electrical stimulation of spinal cord over the skin combined with physical therapy to improve walking and standing functions', 'armGroupLabels': ['Transcutaneous spinal stimulation & Physical therapy']}, {'name': 'Physical Therapy', 'type': 'OTHER', 'description': 'physical therapy to improve walking and standing functions', 'armGroupLabels': ['Physical therapy only', 'Transcutaneous spinal stimulation & Physical therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Soshi Samejima', 'role': 'CONTACT', 'email': 'soshis@uw.edu'}, {'name': 'Chet Moritz', 'role': 'CONTACT', 'email': 'ctmoritz@uw.edu'}, {'name': 'Chet Moritz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Soshi Samejima, DPT, MS', 'role': 'CONTACT', 'email': 'soshis@uw.edu', 'phone': '206 221-8961'}, {'name': 'Chet Moritz, PhD', 'role': 'CONTACT', 'email': 'ctmoritz@uw.edu', 'phone': '206 221-2842'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chet Moritz', 'investigatorAffiliation': 'University of Washington'}}}}