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ClinicalTrials.gov ID

NCT06281223

Lead Sponsor

Fondation Ophtalmologique Adolphe de RothschildNETWORK

Overall Status

Recruiting

Study Type

Observational

Enrollment

50Estimated

Last Update Posted

Jun 11, 2025Actual

Start Date

Feb 26, 2024Actual

Primary Completion Date

May 2026Estimated

Completion Date

May 2026Estimated

Official Title

Study of Brain-spinal Cord Neural Connectivity in Spasticity

Brief Summary

Little is known about the peripheral and central mechanisms of action of selective dorsal rhizotomy surgery for the treatment of spasticity. A better understanding of these mechanisms will enable us to improve the surgical procedure. This will require cortico-medullo-radiculo-muscular recordings never before performed and published in the literature, and the identification of variations in connectivity correlated with the clinic.

• Spasticity, Muscle

• intraoperative neuroelectrophysiological monitoring

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Fondation Ophtalmologique Adolphe de RothschildNETWORK

pvayssiere@for.paris01.48.03.77.29