Cerebral PalsyNCT07516067
Spinal Cord Stimulation for Children With Cerebral Palsy
A study testing Transcutaneous Spinal Cord Stimulation (tSCS) in people with Cerebral Palsy and Spasticity, run by Martin Piazza at 1 site in United States.
Trial summary
The goal of this clinical trial is to help understand spinal cord excitability in children with cerebral palsy compared to neurologically typical children. The main questions it aims to answer are: What are the mechanisms of spinal circuit hyperexcitability in CP? Can transcutaneous spinal cord stimulation reduce… Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Spasticity
- What is being tested?
- Transcutaneous Spinal Cord Stimulation (tSCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2026to Dec 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 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient-Participant Group (Children with Cerebral Palsy)
- Children aged 5 to 17 years with a confirmed diagnosis of cerebral palsy.
- Gross Motor Function Classification System (GMFCS) Levels I to IV, able to walk with or without assistance (walker or cane). This classification will have been completed by Dr. Martin Piazza and his Movement Disorders clinic team.
- Stable medical condition without recent surgeries or interventions that could affect motor function.
- Must be able to communicate basic needs and follow simple instructions.
- Provision of informed consent by a parent or legal guardian, with assent from the child as appropriate.
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- Control Group (Children without Neurological Diagnoses)
- Children aged 5 to 17 years with no history of neurological diagnoses.
- Must be fully ambulatory without assistance.
- Must be able to communicate basic needs and follow simple instructions.
- Provision of informed consent by a parent or legal guardian, with assent from the child as appropriate.
Who cannot join
- Presence of implanted medical devices (e.g., baclofen pumps, deep brain stimulators) that may interfere with TSCS.
- Severe scoliosis or spinal deformities that could affect the delivery of tSCS.
- Uncontrolled epilepsy or a history of frequent seizures.
- Severe cognitive impairments limiting the ability to comply with study procedures.
- Skin conditions or open wounds at the site of stimulation.
- Participation in other interventional studies that may confound results.
- Any serious disease or disorder (e.g. cancer, severe cardiac or respiratory disease, etc.) that could affect ability to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martin G Piazza, MD contact
United States1 site, 1 recruiting
- Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Bailey McDonald, BS, 412-692-9966, mcdonaldbm3@upmc.edu
Martin G Piazza, MD, piazzamg@upmc.edu
About this study
Official title: Transcutaneous Spinal Cord Stimulation to Treat Spasticity in Children With Cerebral Palsy
The goal of this clinical trial is to help understand spinal cord excitability in children with cerebral palsy compared to neurologically typical children. The main questions it aims to answer are:
- What are the mechanisms of spinal circuit hyperexcitability in CP?
- Can transcutaneous spinal cord stimulation reduce spinal circuit hyperexcitability?
Participants with cerebral palsy will be asked to complete:
- Movement and strength exercises
- Mild, non-invasive stimulation on the back and legs that feels like a light tap.
- Gentle, non-invasive tests that help us see how the brain and the spinal cord communicate with the muscles
Read the detailed description
This is a clinical trial designed to evaluate spinal circuit hyperexcitability in children with cerebral palsy (CP) and to explore the potential of transcutaneous spinal cord stimulation (tSCS) to reduce excitability and improve spasticity. The investigators will also examine the mechanisms underlying this potential reduction of spinal hyperexcitability.
The investigators will non-invasively record a range of electrophysiological responses using surface electrodes while participants perform isometric tasks. These recordings will help to better understand the differences in spinal excitability between children with CP and typically developing peers and will provide early insight into how tSCS might modulate these responses.
This study has two aims: The first aim is to evaluate spinal circuit excitability in Children with CP and in children without neurological conditions (controls). Several electrophysiological markers will be collected, including sensory reflex responses, reciprocal inhibition, motoneuron firing patterns, and motor evoked potential by transcranial magnetic stimulation. The second aim is to assess the impact of tSCS on spasticity and hypertonia in CP. To achieve this aim, the same electrophysiological measurements of spinal excitability will be repeated during non-invasive transcutaneous spinal cord stimulation in patient-participants (children with CP).
- Conditions
- Cerebral Palsy, Spasticity
- Being tested
- Transcutaneous Spinal Cord Stimulation (tSCS)
- Keywords
- Cerebral Palsy, Spasticity, Spinal Cord Stimulation, tSCS, TMS, Transcutaneous Spinal Cord Stimulation, transcranial magnetic stimulation
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Spinal Cord Stimulation (tSCS)Device
Transcutaneous spinal cord stimulation (tSCS) will be administered using the Digitimer DS8R Biphasic Constant Current Stimulator, an external isolated stimulator system used in human research. The DS8R delivers controlled electrical pulses with adjustable stimulation parameters.
tSCS will be delivered at frequencies between 30-50 Hz with 1 ms pulse width and a biphasic waveform. Self-adhesive surface electrodes will be positioned longitudinally over the thoracolumbar region at T11-L1 (cathodes) and over the iliac crests (anodes).
In children with cerebral palsy, electrophysiological and clinical assessments will be conducted before, during, and after stimulation to evaluate changes in spinal excitability, spasticity, and motor function. Stimulation is administered during supervised study visits.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Cerebral Palsy Group | Experimental | Transcutaneous spinal cord stimulation (tSCS) will be administered using the Digitimer DS8R Biphasic Constant Current Stimulator, an external isolated stimulator system used in human research. The DS8R delivers controlled electrical pulses with adjustable stimulation parameters. tSCS will be delivered at frequencies between 30-50 Hz with 1 ms pulse width and a biphasic waveform. Self-adhesive surface electrodes will be positioned longitudinally over the thoracolumbar region at T11-L1 (cathodes) and over the iliac crests (anodes). In children with cerebral palsy, electrophysiological and clinical assessments will be conducted before, during, and after stimulation to evaluate changes in spinal excitability, spasticity, and motor function. Stimulation is administered during supervised study visits. Receives: Device: Transcutaneous Spinal Cord Stimulation (tSCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in H-reflex with Transcutaneous Spinal Cord Stimulation
The primary outcome is H-reflex peak-to-peak amplitude with transcutaneous spinal cord stimulation (tSCS).
Success criteria is measured as a reduction in 20 percent of peak-to-peak amplitude of the H-reflex.
Measured: Measured during 1 of up to 3 research sessions over up to 16 weeks
Modified Ashworth Scale
The primary outcome is the spasticity measured by the Modified Ashworth Scale with and without tSCS. The Modified Ashworth Scale is used to assess muscle spasticity. The scale is as follows:
0 = No increase in muscle tone;
1 = Slight increase in tone giving a catch when the limb is moved in flexion or extension;
1+ = Slight increase in muscle tone, indicated by a catch followed by minimal resistance throughout range of motion (ROM); 2 = More marked increase in tone through most of the ROM, but the limb easily flexed; 3 = Considerable increase in tone, passive movement difficult; 4 = Limb rigid in flexion or extension;
Higher scores represent greater spasticity. Success criteria is measured as a reduction of at least 1 point in average across muscles. Scores will be averaged across assessed muscle groups to calculate a mean Modified Ashworth Scale score for each participant.
Measured: Measured during 1 of up to 3 research sessions over up to 16 weeks
Secondary outcomes (3)
TMS motor evoked potential
A reduction in TMS motor evoked potential with tSCS is expected. Success criteria is measured as a decrease in 20 percent of the peak-to-peak amplitude with tSCS.
Measured: Measured during 1 of up to 3 research sessions over up to 16 weeks
Reciprocal inhibition between antagonist muscles with tSCS
Reciprocal inhibition will be tested by conditioning the H-reflex (elicited by stimulating at the tibial nerve) with a prior (between 1 and 5 ms) stimulation of the deep peroneal nerve. The results will be compared in CP vs control to determine its contribution in spinal hyperexcitability in CP. Additionally, the effect of tSCS in CP will be compared to determine whether tSCS can normalize hyperexcitability in CP. Success criteria is measured as a change in reciprocal inhibition of 20 percent towards the values in control participants.
Measured: Measured during 1 of up to 3 research sessions over up to 16 weeks
Motoneuron excitability
The investigators will measure the persistent inward currents of motoneurons as a measure of motoneuron excitability . A reduction in persistent inward current with tSCS is expected. The investigators will compare the results in CP vs control to determine its contribution in spinal hyperexcitability in CP. Additionally, the effect of tSCS in CP will be compared to determine whether tSCS can normalize hyperexcitability in CP. Success criteria is measured as a change in motoneuron excitability of 20 percent towards the values obtained in control participants.
Measured: Measured during 1 of up to 3 research sessions over up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start30 Mar 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin Piazza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Martin Piazza, University of Pittsburgh
- Investigators
- Martin G Piazza, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516067
- Sponsor's protocol ID
- STUDY25010142
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Cord Stimulation to Treat Spasticity in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07516067
- Acronym / sponsor ID
- STUDY25010142
- Conditions
- Cerebral Palsy, Spasticity
- Keywords
- Cerebral Palsy, Spasticity, Spinal Cord Stimulation, tSCS, TMS, Transcutaneous Spinal Cord Stimulation, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Martin PiazzaUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Apr 2026 (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.
The goal of this clinical trial is to help understand spinal cord excitability in children with cerebral palsy compared to neurologically typical children. The main questions it aims to answer are:
- What are the mechanisms of spinal circuit hyperexcitability in CP?
- Can transcutaneous spinal cord stimulation reduce spinal circuit hyperexcitability?
Participants with cerebral palsy will be asked to complete:
- Movement and strength exercises
- Mild, non-invasive stimulation on the back and legs that feels like a light tap.
- Gentle, non-invasive tests that help us see how the brain and the spinal cord communicate with the muscles
Detailed description
This is a clinical trial designed to evaluate spinal circuit hyperexcitability in children with cerebral palsy (CP) and to explore the potential of transcutaneous spinal cord stimulation (tSCS) to reduce excitability and improve spasticity. The investigators will also examine the mechanisms underlying this potential reduction of spinal hyperexcitability.
The investigators will non-invasively record a range of electrophysiological responses using surface electrodes while participants perform isometric tasks. These recordings will help to better understand the differences in spinal excitability between children with CP and typically developing peers and will provide early insight into how tSCS might modulate these responses.
This study has two aims: The first aim is to evaluate spinal circuit excitability in Children with CP and in children without neurological conditions (controls). Several electrophysiological markers will be collected, including sensory reflex responses, reciprocal inhibition, motoneuron firing patterns, and motor evoked potential by transcranial magnetic stimulation. The second aim is to assess the impact of tSCS on spasticity and hypertonia in CP. To achieve this aim, the same electrophysiological measurements of spinal excitability will be repeated during non-invasive transcutaneous spinal cord stimulation in patient-participants (children with CP).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Cerebral Palsy Group | Experimental | Device: Transcutaneous Spinal Cord Stimulation (tSCS)Transcutaneous spinal cord stimulation (tSCS) will be administered using the Digitimer DS8R Biphasic Constant Current Stimulator, an external isolated stimulator system used in human research. The DS8R delivers controlled electrical pulses with adjustable stimulation parameters. tSCS will be delivered at frequencies between 30-50 Hz with 1 ms pulse width and a biphasic waveform. Self-adhesive surface electrodes will be positioned longitudinally over the thoracolumbar region at T11-L1 (cathodes) and over the iliac crests (anodes). In children with cerebral palsy, electrophysiological and clinical assessments will be conducted before, during, and after stimulation to evaluate changes in spinal excitability, spasticity, and motor function. Stimulation is administered during supervised study visits. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Patient-Participant Group (Children with Cerebral Palsy)
- Children aged 5 to 17 years with a confirmed diagnosis of cerebral palsy.
- Gross Motor Function Classification System (GMFCS) Levels I to IV, able to walk with or without assistance (walker or cane). This classification will have been completed by Dr. Martin Piazza and his Movement Disorders clinic team.
- Stable medical condition without recent surgeries or interventions that could affect motor function.
- Must be able to communicate basic needs and follow simple instructions.
Key exclusion criteria (7 listed)
- Presence of implanted medical devices (e.g., baclofen pumps, deep brain stimulators) that may interfere with TSCS.
- Severe scoliosis or spinal deformities that could affect the delivery of tSCS.
- Uncontrolled epilepsy or a history of frequent seizures.
- Severe cognitive impairments limiting the ability to comply with study procedures.
- Skin conditions or open wounds at the site of stimulation.
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 |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation (tSCS)Transcutaneous spinal cord stimulation (tSCS) will be administered using the Digitimer DS8R Biphasic Constant Current Stimulator, an external isolated stimulator system used in human research. The DS8R delivers controlled electrical pulses with adjustable stimulation parameters. tSCS will be delivered at frequencies between 30-50 Hz with 1 ms pulse width and a biphasic waveform. Self-adhesive surface electrodes will be positioned longitudinally over the thoracolumbar region at T11-L1 (cathodes) and over the iliac crests (anodes). In children with cerebral palsy, electrophysiological and clinical assessments will be conducted before, during, and after stimulation to evaluate changes in spinal excitability, spasticity, and motor function. Stimulation is administered during supervised study visits. | Device | Cerebral Palsy Group |
Primary outcome
Change in H-reflex with Transcutaneous Spinal Cord Stimulation
Time frame: Measured during 1 of up to 3 research sessions over up to 16 weeks
The primary outcome is H-reflex peak-to-peak amplitude with transcutaneous spinal cord stimulation (tSCS). Success criteria is measured as a reduction in 20 percent of peak-to-peak amplitude of the H-reflex.
Modified Ashworth Scale
Time frame: Measured during 1 of up to 3 research sessions over up to 16 weeks
The primary outcome is the spasticity measured by the Modified Ashworth Scale with and without tSCS. The Modified Ashworth Scale is used to assess muscle spasticity. The scale is as follows: 0 = No increase in muscle tone; 1 = Slight increase in tone giving a catch when the limb is moved in flexion or extension; 1+ = Slight increase in muscle tone, indicated by a catch followed by minimal resistance throughout range of motion (ROM); 2 = More marked increase in tone through most of the ROM, but the limb easily flexed; 3 = Considerable increase in tone, passive movement difficult; 4 = Limb rigid in flexion or extension; Higher scores represent greater spasticity. Success criteria is measured as a reduction of at least 1 point in average across muscles. Scores will be averaged across assessed muscle groups to calculate a mean Modified Ashworth Scale score for each participant.
3 secondary outcomes
TMS motor evoked potential
Time frame: Measured during 1 of up to 3 research sessions over up to 16 weeks
Reciprocal inhibition between antagonist muscles with tSCS
Time frame: Measured during 1 of up to 3 research sessions over up to 16 weeks
Motoneuron excitability
Time frame: Measured during 1 of up to 3 research sessions over up to 16 weeks
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 7 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Martin G Piazza, MD contact
Martin G Piazza, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Spinal Cord Stimulation (tSCS) in people with Cerebral Palsy and Spasticity, run by Martin Piazza at 1 site in United States.
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 11 inclusion and 7 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 7 Apr 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 States. 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 Bailey McDonald, BS (412-692-9966, mcdonaldbm3@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in H-reflex with Transcutaneous Spinal Cord Stimulation (time frame: Measured during 1 of up to 3 research sessions over up to 16 weeks). The study lists 2 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 7 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.