tSCS in Children and Young People With HCP

Official title

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

Overview

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).

Detailed description

Cerebral palsy (CP) is a condition that affects movement and posture due to brain development issues in babies or young children. Hemiplegic CP (HCP) is a condition where one side of the body is paralysed. Symptoms like stiffness in the arms and legs usually appear early and can make everyday tasks, such as reaching or holding objects difficult. Improving arm and hand function is crucial for increasing independence and quality of life for children with HCP. This study investigates a technique called Transcutaneous Spinal Cord Stimulation (tSCS). tSCS uses sticky pads placed on the skin to deliver a mild electrical current. This current stimulates nerves to help them send signals to the muscles, potentially improving arm and hand movements. Research has demonstrated that tSCS can provide benefits in the lower limb for children and young people (CYP) with CP, those with spinal cord injuries and healthy individuals. In this project, we will test the feasibility and effectiveness of tSCS in 18 CYP (aged 12-21 years) with HCP. The participant will attend two sessions. Each session will last approximately 60-90 minutes and will include:

* A Baseline Assessment (before training) * A 30-minute Upper Limb Task Training (ULTT) * One session will involve transcutaneous spinal cord stimulation (tSCS) combined with ULTT * One session will involve ULTT only (no stimulation) * The order is randomised, meaning participants do the stimulation session first or second * A Post-Training Assessment

Interventions

• Device Digimer 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).

Primary outcome measures

• Participants with stimulation-site skin reaction (Yes/No; photographic assessment) [Time frame: At the first session: Baseline (pre-tSCS) and immediately post-tSCS]
• Heart Rate Category (beats per minute) [Time frame: [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) [Time frame: 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) [Time frame: 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)]
• Muscle Activity: Mean motor threshold to elicit ≥50 µV sEMG response (mA) - Delsys Trigno / Digitimer DS8R [Time frame: 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).]
• Modified Ashworth Scale (0-4; higher = worse) - worst upper-limb muscle score (more affected limb) [Time frame: 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)]
• Systolic Blood Pressure Category (mmHg) [Time frame: Baseline (pre-tSCS); During tSCS (10 minutes after start); Immediately post-tSCS (within 10 minutes after end) during a single session.]
• Diastolic Blood Pressure Category (mmHg) [Time frame: Baseline (pre-tSCS); During tSCS (10 minutes after start); Immediately post-tSCS (within 10 minutes after end) during a single session.]

Secondary outcome measures (2)

• Participant-reported experience with stimulation - response frequencies (project-specific questionnaire) [Time frame: Immediately post-final tSCS session [first session] (within 10 minutes), single administration.]
• ABILHAND-Kids total raw score (0-42; higher = better manual ability) [Time frame: 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).]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• University of Leeds — Leeds

Identifiers

NCT: NCT07247812 · 2024-NCT59

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗