tSCS in Children and Young People With HCP

NCT07247812 | Recruiting

• 1 other identifier: 2024-NCT59
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cerebral Palsy Spastic Hemiplegic

Keywords

Cerebral palsy; Transcutaneous Spinal Cord Stimulation; Hemiplegic Cerebral Palsy; Upper Extremity Function

Outcome Measures

Primary Outcomes (8)

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

  Standardised photographs of the back will be obtained at each time point and reviewed by an independent clinician (not part of the study team). A skin reaction is defined as any visible erythema at/near the electrode site and will be recorded on a Yes/No erythema scale (0 = No erythema; 1 = Yes erythema). Results will be reported as the number and proportion of participants with ≥1 skin reaction during the session and by time point.

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

• Heart Rate Category (beats per minute)

  Heart rate will be measured immediately before and after tSCS using an OMRON M3 device. For each participant, a blinded independent clinician will classify the post-stimulation change relative to Baseline as one of three categories: Increased, Decreased, or No Apparent Change. Study results will be summarised as the number and proportion of participants in each category and described narratively.

  [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)

  Handgrip and pinch strength will be measured with handheld dynamometers (adjustable handle/pads; peak-hold). At each time point, participants perform 3 maximal attempts per measure; the average (mean) is calculated for handgrip and for pinch. Results will be summarised as mean (SD) by timepoint and change from pre to post within each session (Post - Pre). Component means (handgrip and pinch) will be presented descriptively as supportive information.

  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)

  Hand function will be assessed with the Jebsen-Taylor Hand Function Test (JTHFT). The protocol includes three subtests: (1) picking up small common objects; (2) stacking checkers; (3) lifting large light and large heavy cans (\~1 lb). Each subtest is timed to completion. Testing is administered with the less affected hand first, then the more affected hand; the primary outcome is the Total Score for the more affected hand. Results will be summarised as mean (SD) seconds by timepoint and change from pre to post within each session (Post - Pre). (Scores for the less affected hand may be presented descriptively as supportive data.)

  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

  Muscle activity will be assessed with surface EMG (Delsys Trigno). Sensors will be placed on the more affected arm over the abductor pollicis brevis, flexor carpi radialis, and extensor carpi radialis longus. Single spinal pulses (1 ms biphasic square-wave) will be delivered every \~5 s using a Digitimer DS8R. For each muscle at each time point, the motor threshold is defined as the lowest stimulation amplitude (mA) that produces an evoked sEMG response ≥50 µV. The participant-level outcome is the mean motor threshold (mA) across the three muscles. Results will be summarised as mean (SD) mA by timepoint and change from Baseline to Post.

  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)

  Spasticity will be assessed with the Modified Ashworth Scale (MAS), scored 0, 1, 1+, 2, 3, 4 (0 = no increase in tone; 4 = rigid; higher scores indicate worse spasticity). The following muscles on the more affected upper limb will be tested in a fixed order: elbow flexors, wrist flexors, finger flexors. At each timepoint, the primary outcome is the worst (highest) MAS score across the tested muscles. Results will be summarised as median by timepoint and change from Pre to Post within each session (Post - Pre).

  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)

  Systolic blood pressure will be measured immediately before and after tSCS using an OMRON M3 device. For each participant, a blinded independent clinician will classify the post-stimulation change relative to Baseline as one of three categories: Increased, Decreased, or No Apparent Change. Study results will be summarised as the number and proportion of participants in each category and described narratively.

  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)

  Diastolic blood pressure will be measured immediately before and after tSCS using an OMRON M3 device. For each participant, a blinded independent clinician will classify the post-stimulation change relative to Baseline as one of three categories: Increased, Decreased, or No Apparent Change. Study results will be summarised as the number and proportion of participants in each category and described narratively.

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

Secondary Outcomes (2)

• Participant-reported experience with stimulation - response frequencies (project-specific questionnaire)

  Immediately post-final tSCS session [first session] (within 10 minutes), single administration.

• ABILHAND-Kids total raw score (0-42; higher = better manual ability)

  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).

Study Arms (2)

transcutaneous spinal cord stimulation (tSCS) combined with Upper Limb Training Task (ULTT)

EXPERIMENTAL

One session will involve transcutaneous spinal cord stimulation (tSCS) combined with ULTT

Device: Digimer DS8R

ULTT ONLY

NO INTERVENTION

one session with ULTT only (no stimulation; tSCS)

Interventions

Digimer DS8R DEVICE

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).

transcutaneous spinal cord stimulation (tSCS) combined with Upper Limb Training Task (ULTT)

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

University of Leeds

Leeds, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Omar NAHHAS, PhD Candidate

CONTACT

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

Sarah Astill, PhD

CONTACT

+ 44 113 343 7267; S.L.Astill@leeds.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: November 25, 2025
• Study Start: April 29, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)