Cerebral Palsy (CP)NCT07715006
Dorsal Root Electrical Stimulation in Children With Cerebral Palsy
A study testing Constant Current Stimulator and Cadwell Guardian System in people with Cerebral Palsy (CP) and Cerebral Palsy, run by Martin Piazza at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate whether dorsal root electrical stimulation could reduce spasticity in children with cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Cerebral Palsy (CP), Cerebral Palsy, Spasticity
- What is being tested?
- Constant Current Stimulator and Cadwell Guardian System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2026to Dec 2029
- 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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 3 to 14
- Diagnosis of Cerebral Palsy
- Require an SDR as determined by the multidisciplinary movement disorders team
- Confirmation that subjects' terms of insurance coverage for their standard of care procedure will not be altered by study enrollment.
Who cannot join
- No exclusion criteria
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 G McDonald, BS, 412-692-9966, mcdonaldbm3@upmc.edu
Martin G Piazza, MD, piazzamg@upmc.edu
About this study
Official title: Dorsal Root Electrical Stimulation to Suppress Spastic Muscle Activation in Children With Cerebral Palsy
The goal of this clinical trial is to evaluate whether dorsal root electrical stimulation could reduce spasticity in children with cerebral palsy (CP).
Read the detailed description
The investigators will recruit participants with CP requiring selective dorsal rhizotomy (SDR) surgery. During SDR, spastic dorsal roots are routinely identified by electrically stimulating each root at low frequency (1 Hz) and measuring the resulting muscle response via electromyography - a procedure called "clinical test stimulation." Dorsal roots that produce an abnormally large and widespread compound muscle action potential (CMAP) are classified as spastic. In this study, the investigators will superimpose higher-frequency dorsal root stimulation (40-5000 Hz) on top of this standard clinical test stimulation and assess whether it suppresses the abnormal large CMAP.
- Being tested
- Constant Current Stimulator, Cadwell Guardian System
- Keywords
- Dorsal root electrical 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.
Constant Current StimulatorDevice
The DS8R is an external isolated stimulator system used in human research (DS8R), delivers controlled electrical pulses with adjustable stimulation parameters.
Cadwell Guardian SystemDevice
The Cadwell Guardian System is a clinical intraoperative system used to deliver stimulation in the dorsal root during SDR.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Palsy Group | Experimental | The investigators will use the DS8R to directly deliver electrical stimulation with hook electrodes to the dorsal roots while testing the spasticity of individual dorsal roots. Receives: Device: Constant Current Stimulator; Device: Cadwell Guardian System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak-to-peak amplitude of the dorsal root reflex
The investigators will assess whether dorsal root electrical stimulation at frequencies (40-5000Hz) can normalize the abnormally large muscle response to electrical stimulation of the same dorsal root at low frequencies that is a signature of spasticity in CP. The investigators will measure the peak-to-peak amplitude of the dorsal root reflex with intramuscular EMGs.
Succes criteria: A 20% reduction in the peak-to-peak amplitude of the spinal reflex
Measured: In session during the surgery (1 session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start16 Jul 2026
- Primary completion1 Nov 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT07715006
- Sponsor's protocol ID
- STUDY26040193
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2026
- Last updated
- 11 Aug 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dorsal Root Electrical Stimulation to Suppress Spastic Muscle Activation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07715006
- Acronym / sponsor ID
- STUDY26040193
- Keywords
- Dorsal root electrical stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Martin PiazzaUniversity, hospital or other
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 Jul 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 evaluate whether dorsal root electrical stimulation could reduce spasticity in children with cerebral palsy (CP).
Detailed description
The investigators will recruit participants with CP requiring selective dorsal rhizotomy (SDR) surgery. During SDR, spastic dorsal roots are routinely identified by electrically stimulating each root at low frequency (1 Hz) and measuring the resulting muscle response via electromyography - a procedure called "clinical test stimulation." Dorsal roots that produce an abnormally large and widespread compound muscle action potential (CMAP) are classified as spastic. In this study, the investigators will superimpose higher-frequency dorsal root stimulation (40-5000 Hz) on top of this standard clinical test stimulation and assess whether it suppresses the abnormal large CMAP.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral Palsy Group | Experimental | Device: Constant Current Stimulator, Device: Cadwell Guardian SystemThe investigators will use the DS8R to directly deliver electrical stimulation with hook electrodes to the dorsal roots while testing the spasticity of individual dorsal roots. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children ages 3 to 14
- Diagnosis of Cerebral Palsy
- Require an SDR as determined by the multidisciplinary movement disorders team
- Confirmation that subjects' terms of insurance coverage for their standard of care procedure will not be altered by study enrollment.
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Constant Current StimulatorThe DS8R is an external isolated stimulator system used in human research (DS8R), delivers controlled electrical pulses with adjustable stimulation parameters. | Device | Cerebral Palsy Group |
| Cadwell Guardian SystemThe Cadwell Guardian System is a clinical intraoperative system used to deliver stimulation in the dorsal root during SDR. | Device | Cerebral Palsy Group |
Primary outcome
Peak-to-peak amplitude of the dorsal root reflex
Time frame: In session during the surgery (1 session)
The investigators will assess whether dorsal root electrical stimulation at frequencies (40-5000Hz) can normalize the abnormally large muscle response to electrical stimulation of the same dorsal root at low frequencies that is a signature of spasticity in CP. The investigators will measure the peak-to-peak amplitude of the dorsal root reflex with intramuscular EMGs. Succes criteria: A 20% reduction in the peak-to-peak amplitude of the spinal reflex
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 11 Aug 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 Constant Current Stimulator and Cadwell Guardian System in people with Cerebral Palsy (CP) and Cerebral Palsy, 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 4 inclusion and 1 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 11 Aug 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?
Peak-to-peak amplitude of the dorsal root reflex (time frame: In session during the surgery (1 session)). 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 11 Aug 2026.