tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy
ConditionCerebral Palsy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age4-17
SponsorShirley Ryan AbilityLab
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Concurrent neurological disease affecting the central nervous system.
Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
Orthopedic dysfunction, injury, or surgery that would impact an individual's ability to use the upper and/or lower extremity
Unhealed fracture or other musculoskeletal impairment that might interfere with upper or lower extremity rehabilitation or testing activities
Trial design
Treatments tested in this trial
- tSCS
- 5-Azacitidine
- Mannitol
- Functional Activity Training
Treatment groups
80 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov