protocolSection identificationModule nctId: NCT06274021, orgStudyIdInfo id: UMMC-IRB-2023-125, briefTitle: Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: University of Mississippi Medical Center, class: OTHER, collaborators name: Methodist Rehabilitation Center, collaborators name: The Craig H. Neilsen Foundation, descriptionModule briefSummary: People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Transcutaneous spinal stimulation is a non-surgical intervention by applying electrical currents using skin electrodes over the lower back and belly.The investigators want to see how well the intervention of transcutaneous spinal stimulation performs by testing different levels of stimulation pulse rates. Also, transcutaneous spinal stimulation is compared to muscle relaxants such as baclofen and tizanidine, commonly given to people with spinal cord injuries, to reduce muscle stiffness and spasms. By doing this, the investigators hope to discover if transcutaneous spinal stimulation similarly reduces muscle spasms and stiffness or if combining both methods works best. This could help improve treatment options for people with spinal cord injuries in the future., conditionsModule conditions: Spinal Cord Injuries, conditions: Spinal Cord Injury, conditions: Spinal Cord Injury Cervical, conditions: Spinal Cord Injury Thoracic, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: This study employs a crossover design, wherein each participant is systematically administered a sequence of five distinct interventions randomly. This approach ensures that every participant receives each intervention in a unique sequence. The design facilitates within-subject comparisons by minimizing inter-individual variability, as each participant effectively serves as their own control across the study phases. The random assignment of intervention sequences aims to balance potential carryover effects and period effects., primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: The participants and assessors are kept unaware of which intervention is being administered. For this, the study drugs are designed to be visually identical for all participants, and the intervention and sham stimulation configuration is set without the assessor being present in the room., enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous spinal stimulation at 100 Hz, interventions name: Transcutaneous spinal stimulation at 50 Hz, interventions name: Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen, interventions name: Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine, interventions name: Sham transcutaneous spinal stimulation, outcomesModule primaryOutcomes measure: Change from baseline of posterior root reflexes (PRRs) recruitment curves., primaryOutcomes measure: Change from baseline of flexion withdrawal reflex (FWR) response amplitude., primaryOutcomes measure: Change from baseline of stretch reflex (SR) response amplitude., primaryOutcomes measure: Change from baseline in muscle stiffness as measured by the Modified Ashworth Scale (MAS),, primaryOutcomes measure: Change from baseline in spasms as measured by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS)., secondaryOutcomes measure: Change from baseline of posterior root reflexes (PRRs) recruitment curves., secondaryOutcomes measure: Change from baseline of flexion withdrawal reflex (FWR) response amplitude., secondaryOutcomes measure: Change from baseline of stretch reflex (SR) response amplitude., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Methodist Rehabilitation Center, city: Jackson, state: Mississippi, zip: 39216, country: United States, contacts name: Dobrivoje S Stokic, MD, DSc, role: CONTACT, phone: 601-364-3314, email: dstokic@mmrcrehab.org, geoPoint lat: 32.29876, lon: -90.18481, locations facility: University of Mississippi Medical Center, city: Jackson, state: Mississippi, zip: 39216, country: United States, contacts name: Matthias J Krenn, PhD, role: CONTACT, phone: 601-364-3413, email: mkrenn@umc.edu, geoPoint lat: 32.29876, lon: -90.18481, hasResults: False