Using non-invasive spinal stimulation to improve arm and hand function in children and young people with hemiplegic cerebral palsy.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.