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

Last updated: April 8, 2025
Sponsor: KK Women's and Children's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Palsy

Treatment

AscenZ-IV neuromodulation device

Clinical Study ID

NCT06921538
2024/00201
  • Ages 6-21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theintervention device (AscenZion-IV stimulator) for management of CP.

Eligible individuals must agree to be audio-recorded.

Exclusion

Exclusion Criteria:

  1. CP patients with epilepsy with recent seizures (&lt;12 months) will be excluded forsafety given the theoretical risks of seizures (abnormal brain electricaldischarges) with transcranial electrical stimulation. We will include those withwell 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 beexcluded from the study, include:

  • Individuals with history of uncontrolled epileptic disorder, seizures, braintumour or trauma, and mental disease

  • Individuals with electrical implanted stimulatory device, such as pacemaker ordefibrillator

  • Individuals with medical devices that are affected by magnets, such asprogrammable shunts.

  • Individuals with pregnancy

  1. CP patients who received any intramuscular botulinum toxin injections within lessthan 6 months (as anti-spasticity effect lasts for 4-6 months).

  2. CP patients who received any musculo-skeletal, brain or nerve-related surgery withinless than 6 months, or major surgery requiring prolonged hospitalisation (&gt;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.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: AscenZ-IV neuromodulation device
Phase:
Study Start date:
October 11, 2024
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

  • KK Women's and Children's Hospital

    Singapore, 229899
    Singapore

    Active - Recruiting

  • National University Hospital Singapore

    Singapore, 119074
    Singapore

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.