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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-21
SponsorKK Women's and Children's Hospital

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

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

KK Women's and Children's Hospital

Lead sponsor

National University Hospital, Singapore

Collaborator