About this trial
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.
Eligibility criteria
Qualifiers
CP patients who participate in this research study,
caregivers of the CP patients taking part in this research study,
implementation staff
qualified clinicians not involved in the intervention or refused to recommend the intervention device (AscenZion-IV stimulator) for management of CP.
Disqualifiers
CP patients with epilepsy with recent seizures (<12 months) will be excluded for safety given the theoretical risks of seizures (abnormal brain electrical discharges) with transcranial electrical stimulation. We will include those with well controlled epilepsy with no recent seizures (within 12 months).
Individuals with history of uncontrolled epileptic disorder, seizures, brain tumour or trauma, and mental disease
Individuals with electrical implanted stimulatory device, such as pacemaker or defibrillator
Individuals with medical devices that are affected by magnets, such as programmable shunts.
Trial design
Treatments tested in this trial
- AscenZ-IV neuromodulation device
Treatment groups
Sponsors and collaborators
KK Women's and Children's Hospital
Lead sponsor
National University Hospital, Singapore
Collaborator