Actively Recruiting
A Novel Home-based Non-invasive Neuromodulation Therapy for Children and Adolescents With Cerebral Palsy
Led by KK Women's and Children's Hospital · Updated on 2025-04-10
60
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
K
KK Women's and Children's Hospital
Lead Sponsor
N
National University Hospital, Singapore
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new home-based, non-invasive neuromodulation therapy called the AscenZ-IV Stimulator for children and adolescents with cerebral palsy (CP). This device combines transcranial Pulse Current Stimulation (tPCS) and Transcutaneous Electrical Nerve Stimulation (TENS) and aims to improve spasticity, motor function, and quality of life. The study includes children and adolescents aged 2 to under 21 years with mild to severe spastic CP classified by the Gross Motor Function Classification System (GMFCS) levels II to V. The study is a crossover randomized controlled trial comparing standard care alone versus standard care plus the AscenZ-IV Stimulation. Participants receive 8 weeks of AscenZ-IV stimulation along with their usual medical interventions and therapy, applied for 30 minutes per day, 5 to 7 sessions per week. Additional stimulation may be given for behavioral and drooling issues if needed. After the intervention phase, participants switch to standard care only for 8 weeks. Following the crossover, they may opt for a 4-week maintenance intervention. Participants will undergo assessments of spasticity, gross motor function, upper limb motor function, gait, and quality of life at baseline, week 8, week 16, and week 20 after maintenance. The study also includes questionnaires and medical record reviews to explore barriers and facilitators for using the device. Caregivers deliver the home-based therapy, and audio recording consent is needed for qualitative parts. The total involvement spans approximately 20 weeks with multiple evaluations to monitor treatment effects and acceptability.
CONDITIONS
Brief Title
A Novel Home-based Non-invasive Neuromodulation Therapy for Children and Adolescents With Cerebral Palsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged between 2 to less than 21 years old
- Diagnosed with mild to severe spastic cerebral palsy classified as GMFCS II, III, IV, or V
- Families with at least one parent or caregiver who has simple or conversational English language skills
- For qualitative interviews, individuals must be CP patients in the study, their caregivers, implementation staff, or qualified clinicians not involved in the intervention
- Individuals must agree to be audio-recorded for qualitative components
You will not qualify if you...
- CP patients with epilepsy who have had seizures within the last 12 months
- Individuals with uncontrolled epileptic disorder, seizures, brain tumor, brain trauma, or mental disease
- Individuals with implanted electrical stimulatory devices such as pacemakers or defibrillators
- Individuals with medical devices affected by magnets, such as programmable shunts
- Individuals who are pregnant
- CP patients who had intramuscular botulinum toxin injections within the last 6 months
- CP patients who had musculoskeletal, brain, or nerve surgery within the last 6 months, or major surgery requiring hospitalization longer than one week within the last 3 months
- Individuals who do not agree to be audio-recorded for qualitative interviews
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Two 8-week treatment periods in a crossover design, with an optional 4-week maintenance period.
Participants receive standard care with or without the home-based AscenZ-IV neuromodulation device. The device is used daily at home for 30 minutes, 5 to 7 sessions per week, and additional sessions for behavioral and drooling issues if necessary.
Visits at baseline, Week 8, Week 16, and Week 20 for assessments
Trial Site Locations
Total: 2 locations
1
National University Hospital Singapore
Singapore, Singapore, 119074
Actively Recruiting
2
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Actively Recruiting
Research Team
Z
Zhi Min Ng, MBBS, MRCPCH
J
Jeremy Lin, MBBS, MRCPCH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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