Brain–spinal cord–muscle connectivity during selective dorsal rhizotomy in children with spasticity
Study of Brain-spinal Cord Neural Connectivity in Spasticity
This project will record brain-to-spinal-cord-to-muscle signals during selective dorsal rhizotomy in children ages 3–17 with spasticity to see how the surgery changes nervous system connections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 2 sites (Nice and 1 other locations) |
| Trial ID | NCT06281223 on ClinicalTrials.gov |
What this trial studies
This observational project uses intraoperative neuroelectrophysiological monitoring to capture cortico-medullo-radiculo-muscular signals that have not previously been recorded during selective dorsal rhizotomy. Participants are children aged 3–17 scheduled for the standard surgical procedure, and the recordings are taken during the operation without altering clinical care. The goal is to map variations in neural connectivity and relate those patterns to clinical presentation to inform refinements of the surgical technique. The work is being conducted at pediatric and neurosurgical centers in Nice and Paris.
Who should consider this trial
Good fit: Children aged 3–17 who are scheduled for selective dorsal rhizotomy, have parental written consent, and are covered by a social security scheme are eligible.
Not a fit: People who are not having selective dorsal rhizotomy, or who have epilepsy, significant psychiatric or neurological disorders under treatment, are under legal protection, or are pregnant/breastfeeding would not qualify and are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, the findings could help surgeons target the procedure more precisely and reduce unwanted motor effects while improving spasticity outcomes.
How similar studies have performed: This approach is novel: cortico-medullo-radiculo-muscular recordings during selective dorsal rhizotomy have not been previously published, so there is little direct prior evidence to rely on.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 3 to 17 years included * scheduled for selective rhizotomy surgery * Having received informed consent to participate in the study (written consent from both parents) * Affiliated or beneficiary of a social security scheme Exclusion Criteria: * Contraindications to selective rhizotomy * History of epilepsy * Known neurological and/or psychiatric disorders with past and/or current medical treatment, or drug addiction * Patient under legal protection * Pregnant or breast-feeding women
Where this trial is running
Nice and 1 other locations
- Hpu Lenval — Nice, France (Recruiting)
- Hfar — Paris, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.