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Recruiting NCT06281223

NCT06281223 Study of Brain-spinal Cord Neural Connectivity in Spasticity

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Clinical Trial Summary
NCT ID NCT06281223
Status Recruiting
Phase
Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Condition Spasticity, Muscle
Study Type OBSERVATIONAL
Enrollment 50 participants
Start Date 2024-02-26
Primary Completion 2026-05

Eligibility & Interventions

Sex All sexes
Min Age 3 Years
Max Age 17 Years
Study Type OBSERVATIONAL
Interventions
intraoperative neuroelectrophysiological monitoring

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 50 participants in total. It began in 2024-02-26 with a primary completion date of 2026-05.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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

Contact & Investigator

Principal Investigator

Pia VAYSSIERE, MD

STUDY DIRECTOR

HFAR

Frequently Asked Questions

Who can join the NCT06281223 clinical trial?

This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Spasticity, Muscle. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06281223 currently recruiting?

Yes, NCT06281223 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fondation Ophtalmologique Adolphe de Rothschild to inquire about joining.

Where is the NCT06281223 trial being conducted?

This trial is being conducted at Nice, France, Paris, France.

Who is sponsoring the NCT06281223 clinical trial?

NCT06281223 is sponsored by Fondation Ophtalmologique Adolphe de Rothschild. The principal investigator is Pia VAYSSIERE, MD at HFAR. The trial plans to enroll 50 participants.

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