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

NCT06921538 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-10

No results posted yet for this 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.

Conditions

  • Cerebral Palsy (CP)

Interventions

DEVICE

AscenZ-IV neuromodulation device

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

Sponsors & Collaborators

  • National University Hospital, Singapore

    collaborator OTHER
  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Zhi Min Ng, MBBS, MRCPCH · KK Women's and Children's Hospital

  • Jeremy Lin, MBBS, MRCPCH · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-11
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06921538 on ClinicalTrials.gov