Using non-invasive spinal stimulation to improve arm and hand function in children and young people with hemiplegic cerebral palsy.
The Effects of Transcutaneous Spinal Cord Stimulation on Upper Extremity Function in Children and Young People With Hemiplegic Cerebral Palsy
This project will test whether mild transcutaneous spinal cord stimulation combined with targeted arm and hand exercises helps improve upper-limb movement in young people (aged 12–21) with hemiplegic cerebral palsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 12 Years to 21 Years |
| Sex | All |
| Sponsor | University of Leeds Academic / other |
| Locations | 1 site (Leeds) |
| Trial ID | NCT07247812 on ClinicalTrials.gov |
What this trial studies
This is a small randomized crossover feasibility study in which 18 participants aged 12–21 with hemiplegic cerebral palsy will each attend two sessions of upper-limb training. One session pairs 30 minutes of targeted arm and hand task training with transcutaneous spinal cord stimulation (tSCS) delivered via surface pads using a Digimer DS8R device, and the other session provides the same training without stimulation. The order of sessions is randomized, and each visit includes baseline and post-training assessments, with sessions lasting about 60–90 minutes. The study will compare immediate changes in motor performance between the stimulation and no-stimulation conditions to determine feasibility and preliminary effectiveness.
Who should consider this trial
Good fit: Ideal candidates are English-speaking boys or girls aged 12–21 with a diagnosis of hemiplegic cerebral palsy who have difficulties with hand function, can perform simple reaching or grasping tasks, are medically stable, and can attend two in-person sessions.
Not a fit: Those unlikely to benefit include people with other neurological diseases, uncontrolled high blood pressure, recent major surgery, uncontrolled seizures, or who cannot tolerate or do not have any voluntary upper-limb movement to practice with training.
Why it matters
Potential benefit: If successful, this could provide a non-invasive adjunct to therapy that improves hand and arm control and helps young people with hemiplegic CP perform daily tasks more independently.
How similar studies have performed: Previous research has shown promising effects of tSCS for lower-limb function in children with cerebral palsy and in adults with spinal cord injury, but its use specifically for upper-limb improvement in hemiplegic CP is novel and limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Age and Gender: Boys and girls aged 12 to 21 years. * Diagnosis: Are diagnosed with Hemiplegic Cerebral Palsy (HCP). * Hand Function: Are experiencing difficulties with hand functions in daily activities. * Medical Stability: Have stable medical conditions without cardiopulmonary disease or seizures. * Motor Capability: Are capable of performing simple motor tasks such as reaching, touching, or grasping objects. * Availability: Are able to attend two sessions * Consent informed: Are able to provide informed consent (or if under 16, will need to have a parent or legal guardian who is willing to provide consent on their behalf). * Language: Are able to speak English (and if under 16, their parent or legal guardian must also be able to speak English) Exclusion Criteria * Other Neurological Conditions: Have neurological diseases other than cerebral palsy. * Blood Pressure: Have uncontrolled or high blood pressure. * Recent Surgeries: Have recently undergone significant surgeries (neurological, cardiac, respiratory, or metabolic) without sufficient recovery time. * Severe Diseases: Have cardiovascular or pulmonary diseases. * Medical Complications: Have ongoing medical complications such as unhealed fractures, contractures, or active infections or cancer. * Protocol Compliance: Are unable to follow study protocols safely. * Epilepsy History: Have a personal or family history of epilepsy. * Recent Injections: Have had botulinum toxin injections within the past six months. * Implanted Devices: Have implanted devices like pacemakers or baclofen pumps. * Exclusion of Participants with Recent Research Involvement: Participants who have taken part in any clinical research study within the last 3 months will be excluded.
Where this trial is running
Leeds
- University of Leeds — Leeds, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Omar NAHHAS, PhD Candidate
- Email: Bsothn@leeds.ac.uk
- Phone: + 44 113 343 7267
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.