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Recruiting Observational

Study of Brain-spinal Cord Neural Connectivity in Spasticity

NCT06281223 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-02-26
Last updated
2025-06-11

Condition(s) studied

Spasticity, Muscle

Investigational drug(s) / intervention(s)

intraoperative neuroelectrophysiological monitoring

intraoperative neuroelectrophysiological monitoring: The procedure involves intraoperative neuroelectrophysiological monitoring. The aim is to record the electrical activity of the central and peripheral nervous system at several levels during a neurosurgical procedure. The equipment used comes from INOMED and consists of : * a recording station (ISIS) * scalp corkscrew electrodes (2 to 4 electrodes) * a 4-pin FSR spinal cord electrode (Ad-Tech) * hook electrodes for roots/radicles (X2) * needle electrodes for muscles (X18) Electrode placement and recording take place in the operating room while the patient is under general anaesthetic (intubated and sedated).

Study 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

Sex
ALL
Min age
3 Years
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • variation in "spontaneous/resting" cortico-medullo-radiculo-muscular synchronization before and after selective rhizotomy surgery — Day 0
    variation in the mean spectral power of the neuronal signal between the brain, spinal cord, roots/radicles and muscles (simultaneous recording levels) before and after surgery. Recordings are expressed as currents, themselves defined by waves. Calculating the average spectral power of the neuronal signal at several points is equivalent to quantifying the power of similarity (frequency and amplitude) between two waves.

Trial sites (2)

FacilityCityRegionStatus
Hpu Lenval Nice France Recruiting
HFAR Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06281223 on ClinicalTrials.gov ↗ ← All trials in France