RecruitingNot ApplicableNCT07247812

tSCS in Children and Young People With HCP

The Effects of Transcutaneous Spinal Cord Stimulation on Upper Extremity Function in Children and Young People With Hemiplegic Cerebral Palsy


Sponsor

University of Leeds

Enrollment

18 participants

Start Date

Apr 29, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 12 YearsMax Age: 21 Years

Inclusion Criteria8

  • 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 Criteria10

  • 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.

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Interventions

DEVICEDigimer DS8R

Transtcuatne Electrical stimulation will be delivered using the Digimer DS8R. The tSCS will be administered in one session only, during which participants will receive continuous tSCS simultaneously with Upper Limb Motor Training (ULTT).


Locations(1)

University of Leeds

Leeds, United Kingdom

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NCT07247812


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