RecruitingNot Applicable

tSCS in Children and Young People With HCP

United Kingdom18 participantsStarted 2026-04-29

Plain-language summary

This work will examine if a technique called Transcutaneous Spinal cord stimulation (tSCS), when used with concurrent specific arm and hand exercises, helps improve arm and hand movements in CYP with HCP. Does Transcutaneous Spinal Cord Stimulation (tSCS), when combined with specific arm and hand exercises, improve upper limb function in children and young people (CYP) with Hemiplegic Cerebral Palsy (HCP)? -To determine the feasibility and effectiveness of Transcutaneous Spinal Cord Stimulation (tSCS) combined with targeted arm and hand exercises in improving the upper limb function in children and young people with Hemiplegic Cerebral Palsy (HCP).

Who can participate

Age range

12 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 pa…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Participants with stimulation-site skin reaction (Yes/No; photographic assessment)

Timeframe: At the first session: Baseline (pre-tSCS) and immediately post-tSCS

Heart Rate Category (beats per minute)

Timeframe: [Time Frame: Baseline (pre-tSCS); During tSCS (10 minutes after start); Immediately post-tSCS (within 10 minutes after end) during a single session.

Hand Strength Index (dynamometry)

Timeframe: Session 1[first visit]: Pre (Baseline, before tSCS); Session 1 [first visit]: Post (immediately after tSCS, within 10 minutes); Session 2 [second visit]: Pre (Baseline, before tSCS); Session 2 [sv]: Post (immediately after tSCS, within 10 minutes)

Jebsen-Taylor Hand Function Test total time (seconds)

Muscle Activity: Mean motor threshold to elicit ≥50 µV sEMG response (mA) - Delsys Trigno / Digitimer DS8R

Timeframe: Session 1: Pre (Baseline, before tSCS); Session 1: Post (immediately after tSCS, within 10 minutes); Session 2: Pre (Baseline, before tSCS); Session 2: Post (immediately after tSCS, within 10 minutes).

Trial details

NCT IDNCT07247812

SponsorUniversity of Leeds

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Omar NAHHAS, PhD Candidate

+ 44 113 343 7267 Bsothn@leeds.ac.uk

View on ClinicalTrials.gov More Cerebral Palsy Spastic Hemiplegic trials