Cerebral Palsy (CP)NCT06921538
A Novel Home-based Non-invasive Neuromodulation Therapy for Children and Adolescents With Cerebral Palsy
A study testing AscenZ-IV neuromodulation device in people with Cerebral Palsy (CP), run by KK Women's and Children's Hospital at 2 sites in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- AscenZ-IV neuromodulation device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSingapore
- Study dates
- 11 Oct 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- CP patients with epilepsy with recent seizures (\<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
Show all 9Show fewer
- 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 (\>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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital Singapore
Singapore, 119074
Jeremy Lin, MBBS, MRCPCH, +65 69082222, jeremy_lin@nuhs.edu.sg
Kyu Eon Jeon
- Recruiting
KK Women's and Children's Hospital
Singapore, 229899
Zhi Min Ng, MBBS, MRCPCH, +65 62255554, ng.zhi.min@singhealth.com.sg
Ting Wei Ng, Bsc (hons) Biomedical Science, +65 88904755, ng.ting.wei@kkh.com.sg
About this study
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.
Read the 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)
- Being tested
- AscenZ-IV neuromodulation device
- Keywords
- neuromodulation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AscenZ-IV neuromodulation deviceDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase.
Quality of Life - Care and Comfort
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.
Measured: At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start11 Oct 2024
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Intervention is non-invasive neuromodulation device
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- National University Hospital, Singapore
- Responsible party
- Principal investigator, Ng Zhi Min, KK Women's and Children's Hospital
- Investigators
- Zhi Min Ng, MBBS, MRCPCH, Principal investigator, KK Women's and Children's HospitalJeremy Lin, MBBS, MRCPCH, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921538
- Sponsor's protocol ID
- 2024/00201
- Status last verified
- Apr 2025
- First submitted
- 18 Nov 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not approved to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Home-based Non-invasive Neuromodulation Therapy for Children and Adolescents With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06921538
- Acronym / sponsor ID
- 2024/00201
- Conditions
- Cerebral Palsy (CP)
- Keywords
- neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- National University Hospital, Singapore
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention is non-invasive neuromodulation device
| Arm | Type | Receives |
|---|---|---|
| Intervention: Standard care + AscenZ-IV Stimulation | Experimental | Device: AscenZ-IV neuromodulation deviceParticipants 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 |
| 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 |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- CP patients with epilepsy with recent seizures (\<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:
- 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 (\>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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AscenZ-IV neuromodulation deviceAscenZ-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 | Device | Intervention: Standard care + AscenZ-IV Stimulation |
Primary outcome
Spasticity
Time frame: 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).
6 secondary outcomes
Gross Motor Function
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase.
Quality of Life - Care and Comfort
Time frame: At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No. Not approved to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhi Min Ng, MBBS, MRCPCH principal investigator
KK Women's and Children's Hospital
Jeremy Lin, MBBS, MRCPCH principal investigator
National University Hospital, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AscenZ-IV neuromodulation device in people with Cerebral Palsy (CP), run by KK Women's and Children's Hospital at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhi Min Ng, MBBS, MRCPCH (+65 62255554, ng.zhi.min@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spasticity (time frame: At baseline, at Week 8 and Week 16 of the crossover design, and final assessments i.e. Week 20 after the maintenance phase.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.