Dorsal Root Electrical Stimulation in Children With Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Constant Current Stimulator, Cadwell Guardian System.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy (CP), Cerebral Palsy, Spasticity, Spasticity Due to Cerebral Palsy. Basic parameters: 3 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dorsal Root Electrical Stimulation to Suppress Spastic Muscle Activation in Children With Cerebral Palsy
Overview
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.
Interventions
- Device Constant Current Stimulator
The DS8R is an external isolated stimulator system used in human research (DS8R), delivers controlled electrical pulses with adjustable stimulation parameters. - Device Cadwell Guardian System
The Cadwell Guardian System is a clinical intraoperative system used to deliver stimulation in the dorsal root during SDR.
Primary outcome measures
- Peak-to-peak amplitude of the dorsal root reflex [Time frame: In session during the surgery (1 session)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- No exclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- UPMC Children's Hospital of Pittsburgh — Pittsburgh
Identifiers
NCT: NCT07715006 · STUDY26040193