Home-based neuromodulation therapy for children with cerebral palsy
A Novel Home-based Non-invasive Neuromodulation Therapy for Children and Adolescents With Cerebral Palsy
This study is testing a new home therapy using electrical stimulation to see if it can help children and teens with cerebral palsy improve their movement and reduce stiffness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 21 Years |
| Sex | All |
| Sponsor | KK Women's and Children's Hospital Government |
| Locations | 2 sites (Singapore and 1 other locations) |
| Trial ID | NCT06921538 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness, feasibility, and acceptability of a novel home-based non-invasive neuromodulation therapy using the AscenZ-IV Stimulator for children and adolescents with cerebral palsy. The therapy combines transcranial Pulse Current Stimulation (tPCS) and Transcutaneous Electrical Nerve Stimulation (TENS) to improve spasticity and motor function. It aims to provide a less labor-intensive and more affordable alternative to traditional treatments, which can be invasive and costly. The study involves a crossover randomized controlled trial design and includes participants aged 2 to under 21 with varying severity of spastic cerebral palsy.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 2 to under 21 with mild to severe spastic cerebral palsy classified as GMFCS II, III, IV, or V.
Not a fit: Patients with epilepsy who have had recent seizures are unlikely to benefit from this study due to safety concerns.
Why it matters
Potential benefit: If successful, this therapy could significantly improve motor function and reduce spasticity in children with cerebral palsy, enhancing their quality of life.
How similar studies have performed: While this approach is novel, preliminary unpublished data from China suggest potential effectiveness, indicating a need for further validation in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Singapore and 1 other locations
- National University Hospital Singapore — Singapore, Singapore (Recruiting)
- KK Women's and Children's Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Zhi Min Ng, MBBS, MRCPCH — KK Women's and Children's Hospital
- Study coordinator: Zhi Min Ng, MBBS, MRCPCH
- Email: ng.zhi.min@singhealth.com.sg
- Phone: +65 62255554
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.