Cerebral Palsy Spastic HemiplegicNCT07247812
tSCS in Children and Young People With HCP
A study testing Digimer DS8R in people with Cerebral Palsy Spastic Hemiplegic, run by University of Leeds at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Cerebral Palsy Spastic Hemiplegic
- What is being tested?
- Digimer DS8R
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Apr 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Leeds
Leeds
Sarah Astill L Professor, PhD, 441133437267, s.l.astill@leeds.ac.uk
About this study
Official title: The Effects of Transcutaneous Spinal Cord Stimulation on Upper Extremity Function in Children and Young People With Hemiplegic Cerebral Palsy
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).
Read the 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
- Conditions
- Cerebral Palsy Spastic Hemiplegic
- Being tested
- Digimer DS8R
- Keywords
- Cerebral palsy, Transcutaneous Spinal Cord Stimulation, Hemiplegic Cerebral Palsy, Upper Extremity Function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digimer DS8RDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Digimer DS8R |
| ULTT ONLY | No intervention | one session with ULTT only (no stimulation; tSCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: [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.
Measured: 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.)
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
A project-specific Participant Feedback Questionnaire (PFQ-tSCS), completed by the participant or caregiver, will capture experience with stimulation across predefined domains: comfort, ease of participation, sensations during the session, skin reactions, discomfort/adverse effects, and overall satisfaction. Items use ordered categorical response options (e.g., None/Mild/Moderate/Severe or Strongly disagree → Strongly agree), plus optional free-text. Outcome data will be reported as the number and proportion of participants in each response category for each item; free-text responses will be summarised narratively.
Measured: Immediately post-final tSCS session [first session] (within 10 minutes), single administration.
ABILHAND-Kids total raw score (0-42; higher = better manual ability)
Manual ability will be assessed with the ABILHAND-Kids Questionnaire (21 items; response options: Impossible = 0, Difficult = 1, Easy = 2). The total raw score is the sum across items (higher scores indicate better manual ability). The questionnaire may be completed by the participant or a caregiver proxy per instrument guidance. Results will be summarised as mean (SD) total score by timepoint and change from Pre to Post within each session (Post - Pre)
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start29 Apr 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy Spastic HemiplegicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Sarah Astill, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247812
- Sponsor's protocol ID
- 2024-NCT59
- Status last verified
- Apr 2026
- First submitted
- 2 Oct 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcutaneous Spinal Cord Stimulation on Upper Extremity Function in Children and Young People With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07247812
- Acronym / sponsor ID
- 2024-NCT59
- Conditions
- Cerebral Palsy Spastic Hemiplegic
- Keywords
- Cerebral palsy, Transcutaneous Spinal Cord Stimulation, Hemiplegic Cerebral Palsy, Upper Extremity Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcutaneous spinal cord stimulation (tSCS) combined with Upper Limb Training Task (ULTT) | Experimental | Device: Digimer DS8ROne session will involve transcutaneous spinal cord stimulation (tSCS) combined with ULTT |
| ULTT ONLY | No intervention | –one session with ULTT only (no stimulation; tSCS) |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digimer DS8RTranstcuatne 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). | Device | transcutaneous spinal cord stimulation (tSCS) combined with Upper Limb Training Task (ULTT) |
Primary outcome
Participants with stimulation-site skin reaction (Yes/No; photographic assessment)
Time frame: At the first session: Baseline (pre-tSCS) and immediately post-tSCS
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.
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.
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.
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)
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.
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)
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.)
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).
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.
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)
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).
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.
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.
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.
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.
2 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy Spastic Hemiplegic
Not yet recruiting
Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.
Cerebral Palsy Spastic Hemiplegic, Functionnal Neurological Disorder
Recruiting
rTMS Treatment of Spasticity in Children With Cerebral Palsy/ Hemiplegia Due to ABI - a RCT
CP (Cerebral Palsy)
Not yet recruiting
VR Versus Plyometric Exercise on Lower Limb Motor Control and Balance in Spastic Hemiplegic Children
Cerebral Palsy
Active, not recruiting
Robot-Assisted Mirror Therapy in the Rehabilitation of Hemiparetic Cerebral Palsy
Cerebral Palsy (CP), Hemiparetic Cerebral Palsy
Recruiting
Effectiveness of Modified Constraint-Induced Movement Therapy Versus Mirror Therapy in Spastic Hemiplegic Cerebral Palsy Children
Spastic Hemiplegic Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digimer DS8R in people with Cerebral Palsy Spastic Hemiplegic, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar NAHHAS, PhD Candidate (+ 44 113 343 7267, Bsothn@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with stimulation-site skin reaction (Yes/No; photographic assessment) (time frame: At the first session: Baseline (pre-tSCS) and immediately post-tSCS). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.