Actively Recruiting

Phase Not Applicable
Age: 6Years - 21Years
All Genders
NCT06921538

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

Led by KK Women's and Children's Hospital · Updated on 2025-04-10

60

Participants Needed

2

Research Sites

55 weeks

Total Duration

On this page

Sponsors

K

KK Women's and Children's Hospital

Lead Sponsor

N

National University Hospital, Singapore

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.

Not Eligible

You will not qualify if you...

  1. CP patients with epilepsy with recent seizures (&lt;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 (&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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

National University Hospital Singapore

Singapore, Singapore, 119074

Actively Recruiting

2

KK Women's and Children's Hospital

Singapore, Singapore, 229899

Actively Recruiting

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Research Team

Z

Zhi Min Ng, MBBS, MRCPCH

CONTACT

J

Jeremy Lin, MBBS, MRCPCH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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