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

NCT ID: NCT06921538

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-11
• Study Completion Date: 2025-11-30

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therapy has been shown to improve spasticity and motor function, as well as reduce direct and indirect costs in China (unpublished).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

Conditions

Cerebral Palsy (CP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention: Standard care + AscenZ-IV Stimulation

Participants randomized as Group 1 first receive both standard care (existing medical interventions, therapy program) and AscenZ-IV Stimulation for 8 weeks (30min/day; 5 to 7 sessions/week, additional 30min/day; 5 to 7 sessions/week for behavioral and drooling issues if necessary). Then, they receive standard care only for another 8 weeks. For participants randomized as Group 2, control condition precedes intervention condition. Subsequently, participants are given the option to receive an additional 4 weeks of intervention for maintenance

Group Type: EXPERIMENTAL

AscenZ-IV neuromodulation device

Intervention Type: 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

Control: Standard care only

Participants randomized as Group 1 first receive both standard care (existing medical interventions, therapy program) and AscenZ-IV Stimulation for 8 weeks (30min/day; 5 to 7 sessions/week, additional 30min/day; 5 to 7 sessions/week for behavioral and drooling issues if necessary). Then, they receive standard care only for another 8 weeks. For participants randomized as Group 2, control condition precedes intervention condition. Subsequently, participants are given the option to receive an additional 4 weeks of intervention for maintenance

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: collaborator

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ng Zhi Min

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhi Min Ng, MBBS, MRCPCH

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Jeremy Lin, MBBS, MRCPCH

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

National University Hospital Singapore

Singapore, , Singapore

Site Status: RECRUITING

KK Women's and Children's Hospital

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Zhi Min Ng, MBBS, MRCPCH

Role: CONTACT

ng.zhi.min@singhealth.com.sg

+65 62255554

Jeremy Lin, MBBS, MRCPCH

Role: CONTACT

jeremy_lin@nuhs.edu.sg

+65 69082222

Facility Contacts

Jeremy Lin, MBBS, MRCPCH

Role: primary

jeremy_lin@nuhs.edu.sg

+65 69082222

Kyu Eon Jeon

Role: backup

Zhi Min Ng, MBBS, MRCPCH

Role: primary

ng.zhi.min@singhealth.com.sg

+65 62255554

Ting Wei Ng, Bsc (hons) Biomedical Science

Role: backup

ng.ting.wei@kkh.com.sg

+65 88904755

Other Identifiers

2024/00201

Identifier Type: -

Identifier Source: org_study_id