protocolSection identificationModule nctId: NCT06313515, orgStudyIdInfo id: STUDY00019529, briefTitle: Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University of Washington, class: OTHER, descriptionModule briefSummary: Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities. The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation (tSCS) for cardiovascular recovery in adults aged 21-65 following chronic motor-complete spinal cord injury (SCI) at or above the thoracic sixth spinal segment (≥T6).The main questions the study aims to answer are:* Conduct tSCS mapping to determine the most effective location and stimulation intensity for BP control in individuals with motor-complete SCI ≥ T6.* Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to sham stimulation with exercise on improving cardiovascular function in individuals with motor-complete SCI ≥T6.* Evaluate the dosage-response of 8 weeks vs. 16 weeks of targeted tSCS paired with arm-crank exercise on cardiovascular function in individuals with motor-complete SCI ≥T6.* Explore the mechanisms involved in cardiovascular recovery with long-term tSCS paired with arm-crank exercise.Participants will:* Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while exercising on an arm-crank bicycle in the first 8 weeks.* Come in for approximately 60 visits over a 6-month period. This includes 2, 8-week periods where the investigators will ask participants to come in 3x per week for spinal cord stimulation and exercise.* During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, physical, and autonomic exam, and will ask questions about quality of life and functioning.Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those who receive a sham stimulation and do moderate arm-crank exercise to see if tSCS is effective at improving cardiovascular and autonomic functioning in those with SCI., conditionsModule conditions: Spinal Cord Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized, single-blind, sham-controlled trial with two arms (tSCS paired with arm-crank exercise compared to sham stimulation with exercise). Participants will be randomized into either the intervention or sham stimulation arm. Those in the sham arm only will initially receive sham stimulation, but then cross over to receive the active treatment arm, such that by the end all participants will have been exposed to the tSCS. tSCS participants will not receive sham stimulation., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous Spinal Cord Stimulation, interventions name: Arm-crank bike exercise, interventions name: Sham Stimulation, outcomesModule primaryOutcomes measure: Change in systolic Blood Pressure (BP) from baseline., primaryOutcomes measure: Change in systolic Blood Pressure during a sit-up test or head-up tilt test., primaryOutcomes measure: Heart rate variability recorded by electrocardiogram (ECG)., secondaryOutcomes measure: Peak oxygen uptake (VO2peak), secondaryOutcomes measure: Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure, secondaryOutcomes measure: International Standards for Neurological Classification of Spinal Cord Injury, secondaryOutcomes measure: International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI), secondaryOutcomes measure: Blood Pressure variability, secondaryOutcomes measure: Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2, secondaryOutcomes measure: Change from baseline- Capabilities of Upper Extremity Test, secondaryOutcomes measure: International Spinal Cord Injury Pain Basic Dataset version 2.0, secondaryOutcomes measure: International Spinal Cord Injury Lower Urinary Tract Function Dataset, secondaryOutcomes measure: International Spinal Cord Injury Bowel Function Dataset, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Washington, status: RECRUITING, city: Seattle, state: Washington, zip: 98195, country: United States, contacts name: Soshi Samejima, DPT, PhD, role: CONTACT, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False