Actively Recruiting
Study of Brain-spinal Cord Neural Connectivity in Spasticity
Led by Fondation Ophtalmologique Adolphe de Rothschild · Updated on 2025-06-11
50
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how the brain and spinal cord interact during selective dorsal rhizotomy surgery to treat muscle spasticity in children and adolescents. This study aims to better understand the nerve mechanisms involved by using advanced recordings of electrical activity in the nervous system, which have not been done before. Insights gained may help improve the surgical procedure for spasticity treatment. The study involves recording electrical signals from the brain, spinal cord, nerve roots, and muscles during the surgery using specialized neuroelectrophysiological monitoring equipment. This includes scalp electrodes, spinal cord electrodes, root electrodes, and muscle needle electrodes placed while the patient is under general anesthesia. The procedure captures nerve activity at multiple levels throughout the operation. Participants aged 3 to 17 years scheduled for this surgery will be involved. Researchers will measure changes in nerve signal synchronization before and after surgery as the primary outcome. The process includes continuous monitoring during the operation, and all data collection occurs in the operating room under anesthesia. The total study participation is tied to the surgical procedure timeline.
CONDITIONS
Brief Title
Study of Brain-spinal Cord Neural Connectivity in Spasticity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 3 to 17 years
- Scheduled for selective rhizotomy surgery
- Written informed consent from both parents
- Affiliated or beneficiary of a social security scheme
You will not qualify if you...
- Contraindications to selective rhizotomy
- History of epilepsy
- Known neurological and/or psychiatric disorders under treatment, or drug addiction
- Patient under legal protection
- Pregnant or breast-feeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day 0
Participants undergo selective rhizotomy surgery during which intraoperative neuroelectrophysiological monitoring is performed to record nervous system activity.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
Hpu Lenval
Nice, France, 06200
Actively Recruiting
2
HFAR
Paris, France, 75019
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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