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

NCT06921538 | Recruiting

• 1 other identifier: 2024/00201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy (CP)

Keywords

neuromodulation

Outcome Measures

Primary Outcomes (1)

• Spasticity

  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).

  At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase.

Secondary Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

Other Outcomes (6)

• Drooling

  At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase

• Behavior

  At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase

• Dystonia Severity

  At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase

Study Arms (2)

Intervention: Standard care + AscenZ-IV Stimulation

EXPERIMENTAL

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

Device: AscenZ-IV neuromodulation device

Control: Standard care only

NO INTERVENTION

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

Interventions

AscenZ-IV neuromodulation device 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: Standard care + AscenZ-IV Stimulation

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• CP patients who participate in this research study,
• caregivers of the CP patients taking part in this research study,
• implementation staff
• 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.

You may not qualify if:

• 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).
• 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
• CP patients who received any intramuscular botulinum toxin injections within less than 6 months (as anti-spasticity effect lasts for 4-6 months).
• 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.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• National University Hospital, Singapore: collaborator

Study Sites (2)

National University Hospital Singapore

Singapore, 119074, Singapore

RECRUITING

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Zhi Min Ng, MBBS, MRCPCH

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

• Jeremy Lin, MBBS, MRCPCH

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi Min Ng, MBBS, MRCPCH

CONTACT

+65 62255554; ng.zhi.min@singhealth.com.sg

Jeremy Lin, MBBS, MRCPCH

CONTACT

+65 69082222; jeremy_lin@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention is non-invasive neuromodulation device

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: April 10, 2025
• Study Start: October 11, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)