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

Not Applicable

Recruiting

• Conditions: Cerebral Palsy (CP)

• Registration Number: NCT06921538
• Lead Sponsor: KK Women's and Children's Hospital

Brief 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.

Detailed 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therapy has been shown to improve spasticity and motor function, as well as reduce direct and indirect costs in China (unpublished).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.

Study Timeline

• Study Start: 2024-10-11
• Study First Submitted: 2024-11-18
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Spasticity	At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase.	Physical assessments using the Modified Tardieu Scale (MTS) for upper and/or lower limbs are performed to assess improvement in spasticity with the aim of reducing the R2-R1 value. R1 refers to 'first catch or resistance' or the angle at which there is initial resistance when the muscle is stretched passively. R2 refers to 'end range resistance' or the angle at which the muscle reaches full range of motion under passive stretch, where resistance decreases or disappears. Min (R2-R1) = 0° indicates no spasticity (better outcome); Max (R2-R1) = 90° indicates severe spasticity (worse outcome).

Secondary Outcome Measures

Name	Time	Method
Gross Motor Function	At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase.	Improvement in gross motor function for CP patients is assessed using the Gross Motor Function Measure 66 (GMFM-66) score. Scoring is based on a 4-point scale (0 - does not initiate, 1 - initiates, 2 - partially completes, 3 - completes, NT - not tested) for each of the 66 items. The minimum GMFM-66 score is 0 (worse outcome), which indicates that the child is unable to perform any of the tasks in the assessment. The maximum GMFM-66 score is 100 (better outcome), which indicates that the child can perform all tasks to the full extent expected for their age.
Upper Limb Motor Function	At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase.	Improvement in manual ability for children with upper limb impairments is assessed using the ABILHAND-Kids assessment composed of 21 assessment items, each scored on a 3-point scale (Impossible, Difficult, Easy). The raw score is undergone Rasch conversion to get a global score ranging from 0 to 40. A higher score indicates better manual ability. ABILHAND-Kids is only assessed for participants with hemi/quadriplegia and MACS I to III.
Gait Function	At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase.	The Gait Outcomes Assessment List (GOAL) is used to assess the quality of walking and how it impacts daily life and mobility. Assessment items include activities of daily living and independence, gait function and mobility, pain, discomfort and fatigue, physical activities, sport and recreation, gait pattern and appearance, as well as use of braces and mobility aids. Each item is scored from 0 (severe limitation) to 5 (no limitation), or 0 (very unhappy) to 4 (very happy), thus giving a total score ranging from 0 (severe limitations in all areas) to maximum 236 (no limitation or optimal walking function in all areas). GOAL is only assessed for CP patients of GMFCS II or III.
Cerebral Palsy-specific Health-related Quality of Life	At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase.	Cerebral Palsy-specific Health-related Quality of Life is assessed using the Pediatric Quality of Life Inventory™ 3.0 Cerebral Palsy Module (PedsQL™ 3.0 Cerebral Palsy Module). Items are measured on a 5-point Likert scale from 0 (Never a problem) to 4 (Almost always a problem). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Scores are transformed to a 1 to 100 scale. Higher scores indicate lower problems thus better cerebral palsy-specific health-related quality of life.
General Health-related Quality of Life	At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase.	General health-related quality of life is assessed using EQ-5D-Y-3L. The items assess 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 possible response levels for each dimension - level 1 (no problem), level 2 (some problems), level 3 (a lot of problems). The minimum total score is represented as 11111 on the index, indicating best health state. The maximum total score is represented as 33333 on the index, indicating worst health state.
Quality of Life - Care and Comfort	At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase.	The ICF-8 items for Care and Comfort is part of the International Classification of Functioning, Disability and Health (ICF) framework. 8 items have been selected, 2 of which assess quality of life in terms of activities and participation, scored from 0 = no difficulty to 4 = complete difficulty. The other 6 items assess quality of life in terms of body function, scored from 0 = no impairment to 4 = complete impairment. The total minimum score is 0 indicating no difficulty and impairment, thus high quality of life, whereas the maximum score is 32 indicating complete difficulty and impairment, thus poor quality of life. ICF-8 is assessed only for subjects with dystonia.

Trial Locations

Locations (2)

National University Hospital Singapore; 🇸🇬 Singapore, Singapore

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore