NCT06921538

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: All
• Age: 6 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the clinical effectiveness, feasibility and acceptability of a novel home-based noninvasive neuromodulation therapy (AscenZ-IV Stimulator) that utilizes transcranial Pulse Current Stimulation (tPCS) and Transcutaneous Electrical Nerve Stimulation (TENS) for children and adolescents with cerebral palsy as a community-based intervention by families and healthcare providers.

Detailed description

Currently there is no cure for CP, with treatments limited to oral medications, physical therapies, splinting and casting, botulinum toxin injections and invasive surgical methods. These approaches are time-consuming, labor-intensive and are associated with high direct and indirect costs which reduce patient adherence over the long term. Some are invasive, short-lasting and associated with high risks. Likewise, there is an unmet clinical need for an alternative therapy that can effectively reduce spasticity and improve motor function while being non-invasive, less labor-intensive, affordable and homebased, with minimal side-effects. The AscenZ-IV neuromodulation device is a novel treatment modality that utilizes 2 non-invasive neuromodulation technologies - tPCS and TENS - concurrently within a device. The home-based, non-invasive AscenZ-IV Stimulator therapy has been shown to improve spasticity and motor function, as well as reduce direct and indirect costs in China (unpublished). The stimulator is HSA-approved for children aged 2 to 12. This study includes children and adolescents with mild to severe Spastic Cerebral Palsy (CP) from age 2 to \<21 and Gross Motor Function Classification System (GMFCS) II, III, IV, V. The hypothesis of this crossover randomized controlled trial is that the application of the AscenZ-IV neuromodulation device is an effective and cost-effective home-based, caregiver-delivered adjunct therapy for children with CP to improve their spasticity, motor function and quality of life. The study is designed as a mixed method approach consisting of a crossover randomized controlled trial, as well as questionnaires and medical records. The former is to compare between standard care (existing medical interventions, therapy program) and intervention (standard care + AscenZ-IV stimulation for 8 weeks) by performing physical and functional assessments. The latter is to understand the key barriers and facilitators for adoption of the AscenZ-IV stimulator for CP.

Conditions

• Cerebral Palsy (CP)

Interventions

Type	Name	Description
DEVICE	AscenZ-IV neuromodulation device	AscenZ-IV neuromodulation device is a novel treatment modality that utilizes 2 non-invasive neuromodulation technologies - tPCS and TENS - concurrently within a device. The home-based, non-invasive AscenZ-IV Stimulator therapy has been shown to improve spasticity and motor function

Timeline

• Start date: 2024-10-11
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2025-04-10
• Last updated: 2025-04-10

Locations

2 sites across 1 country: Singapore