Home-Based Non-Invasive Neuromodulation Therapy Using AscenZ-IV Device for Children and Adolescents with Spastic Cerebral Palsy

What this Trial Is About

Researchers are evaluating a new home-based, non-invasive neuromodulation therapy called the AscenZ-IV Stimulator for children and adolescents with cerebral palsy CP. This device combines transcranial Pulse Current Stimulation tPCS and Transcutaneous Electrical Nerve Stimulation TENS and aims to improve spasticity, motor function, and quality of life. The study includes children and adolescents aged 2 to under 21 years with mild to severe spastic CP classified by the Gross Motor Function Classification System GMFCS levels II to V. The study is a crossover randomized controlled trial comparing standard care alone versus standard care plus the AscenZ-IV Stimulation. Participants receive 8 weeks of AscenZ-IV stimulation along with their usual medical interventions and therapy, applied for 30 minutes per day, 5 to 7 sessions per week. Additional stimulation may be given for behavioral and drooling issues if needed. After the intervention phase, participants switch to standard care only for 8 weeks. Following the crossover, they may opt for a 4-week maintenance intervention. Participants will undergo assessments of spasticity, gross motor function, upper limb motor function, gait, and quality of life at baseline, week 8, week 16, and week 20 after maintenance. The study also includes questionnaires and medical record reviews to explore barriers and facilitators for using the device. Caregivers deliver the home-based therapy, and audio recording consent is needed for qualitative parts. The total involvement spans approximately 20 weeks with multiple evaluations to monitor treatment effects and acceptability.

A Novel Home-based Non-invasive Neuromodulation Therapy for Children and Adolescents With Cerebral Palsy