Home-based neuromodulation therapy for children with cerebral palsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 (\&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.

Where it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Outcomes of tone-management surgery in children with spastic/dystonic quadriplegia

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• Wearable eye tracking during bimanual tasks in children with cerebral palsy

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• Dorsal Root Electrical Stimulation to Help Spasticity in Children with Cerebral Palsy

  This study tests whether adding dorsal root electrical stimulation during SDR surgery can lessen spasticity in children with cerebral palsy.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07715006

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.