protocolSection identificationModule nctId: NCT06300996, orgStudyIdInfo id: STUDY23110042, briefTitle: Spinal Cord Stimulation for the Treatment of Motor Deficits in People With Spinal Muscular Atrophy - Upper Limb, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2029-05, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Marco Capogrosso, class: OTHER, collaborators name: Roche-Genentech, descriptionModule briefSummary: Spinal cord stimulation (SCS) has shown remarkable efficacy in restoring motor function in people with spinal cord injury by recruiting afferent input to enhance the responsiveness of spared neural circuits to residual cortical inputs. This pilot will test if SCS can show evidence to improve motor deficits in people with Type 2, 3, or 4 spinal muscular atrophy (SMA). The investigators will enroll up to six subjects with Type 2, 3, or 4 SMA aged 16 or older that show quantifiable motor deficits of the upper body. The investigators will then implant the subjects with percutaneous, linear spinal leads near the cervical spinal cord for a period of up to 29 days. Although these leads are not optimized for motor function but rather for their clinically approved indication of treating pain, the investigators believe they provide a safe technology enabling our team to perform scientific measurement necessary to evaluate potential for effects of SCS in motor paralysis with SMA. After the end of the study, the leads will be explanted., conditionsModule conditions: Spinal Muscular Atrophy, conditions: Spinal Muscular Atrophy Type 3, conditions: Spinal Muscular Atrophy Type II, conditions: Spinal Muscular Atrophy 4, conditions: SMA, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single-arm, open-label study performed to quantify variables that are predictive of the efficacy of spinal cord stimulation to improve motor control., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Spinal Cord Stimulator (Octopolar Medtronic Vectris Leads), outcomesModule primaryOutcomes measure: Muscle Weakness Torque, primaryOutcomes measure: Number and Severity of Adverse Events, secondaryOutcomes measure: Muscle Weakness Muscle Activation, secondaryOutcomes measure: Motor Function ROM, secondaryOutcomes measure: Motor Function RULM, secondaryOutcomes measure: Motor Function Fatigue, secondaryOutcomes measure: Discomfort/Pain, secondaryOutcomes measure: Sensorimotor Network Structure Density, secondaryOutcomes measure: Impression, secondaryOutcomes measure: Sensorimotor Network Structure Integrity, secondaryOutcomes measure: Sensorimotor Network Function, secondaryOutcomes measure: Cortico-spinal Tract Integrity, secondaryOutcomes measure: Spinal Circuit Excitability, secondaryOutcomes measure: Motoneuron Firing Rates, secondaryOutcomes measure: Motor Firing Number, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Pittsburgh, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, contacts name: Sydney Bader, MS, role: CONTACT, email: syb17@pitt.edu, contacts name: Cierra Clark, MS, role: CONTACT, email: cic27@pitt.edu, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False