tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy

A vizsgálat adatai

Ki végzi

Shirley Ryan AbilityLab

Azonosító

NCT07433023

A regiszteradat frissítve

2026. november 5.

Eredeti leírás

This is an intervention study to investigate the impact of spinal stimulation on mobility outcomes in children with Cerebral Palsy. Participants will complete a 16-week training program with weekly sessions of spinal stimulation and walking or activity-based training. Participants will also have the option to participate in a randomized control trial to investigate the impact of 5-Azacitidine combined with the spinal stimulation to further affect mobility outcomes.A teljes eredeti leírásKevesebb

Advancing Neurorehabilitation: Evaluating Transcutaneous Spinal Stimulation and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy

This is an intervention study to investigate the impact of spinal stimulation on mobility outcomes in children with Cerebral Palsy. Participants will complete a 16-week training program with weekly sessions of spinal stimulation and walking or activity-based training. Participants will also have the option to participate in a randomized control trial to investigate the impact of 5-Azacitidine combined with the spinal stimulation to further affect mobility outcomes.

Bevonási feltételek: Diagnosis of cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) Levels I-V; Between 4 and 17 years old at the time of enrollment/consent; Diagnosis of spastic CP hemiplegia, diplegia, or quadriplegia; Stable medical condition as determined by the investigator; Adequate caregiver support to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the Investigator; Capable of performing simple cued motor tasks and can follow 2-3 step commands; Capable of communicating an accurate yes or no answer to questions according to parent or guardian; Able to localize pain/ discomfort; Physician approval for participation; Parent/ guardian permission.

Kizáró feltételek: Concurrent neurological disease affecting the central nervous system; Orthopedic dysfunction, injury, or surgery that would impact an individual's ability to use the upper and/or lower extremity; Implanted stimulator (e.g., epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant) or drug delivery device (e.g., baclofen pump); Plans to receive a vaccine within 30 days of the planned AZA or placebo injection to take place at week 10; Orthopedic surgery completed in the prior 12 months; Intrathecal medication titration that may affect muscle spasticity; Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention; Unhealed fracture or other musculoskeletal impairment that might interfere with upper or lower extremity rehabilitation or testing activities; Dependence on an electro-magnetic medical implant (e.g., cardiac pacemaker, implanted drug pump), ventilation support, or another external device; History of uncontrolled seizures; Severe cortico-visual impairment; Active cancer or cancer in remission less than 5 years; Clinically significant depression, psychiatric disorders, or ongoing drug abuse; Immunodeficiency or hematologic condition; Allergy to AZA or mannitol; Any other health condition or diagnosis not listed above that may put the participant at risk as determined by the investigator or treating physician; Unexplained presence of persistent complaints of pain of any kind; Unable to localize pain/discomfort; Active pressure sores; Pregnancy; Botulinum toxin treatment within 3 months preceding enrollment unless given approval by the treating physician; Current enrollment in a conflicting research study.

ClinicalTrials.gov NCT07433023