💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
Children and adolescents aged between 2 to \<21 years old with mild to severe Spastic Cerebral Palsy (CP) classified on Gross Motor Function Classification System (GMFCS) II, III, IV, V. Families with at least one parent or caregiver has simple or conversational English language skill.
To be eligible for the qualitative interview components of this research study, the individuals should be recognised as one of the following:
1. CP patients who participate in this research study,
2. caregivers of the CP patients taking part in this research study,
3. implementation staff
4. qualified clinicians not involved in the intervention or refused to recommend the intervention device (AscenZion-IV stimulator) for management of CP.
Eligible individuals must agree to be audio-recorded.
Exclusion Criteria:
1. 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).
2. CP patients who have contra-indications to the use of tPCS and/or TENS will be excluded from the study, include:
* 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.
* Individuals with pregnancy
3. CP patients who received any intramuscular botulinum toxin injections within less than 6 months (as anti-spasticity effect lasts for 4-6 months).
4. CP patients who received any musculo-skeletal, brain or nerve-related surgery within less than 6 months, or major surgery requiring prolonged hospitalisation (\>1week) within less than 3 months.
Those who do not agree to be audio-recorded will be excluded for the qualitative interview components of this research study.
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