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Recruiting NCT06281223

Study of Brain-spinal Cord Neural Connectivity in Spasticity

Observational Spasticity, Muscle

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intraoperative neuroelectrophysiological monitoring.
Who it may be relevant to
Registry conditions: Spasticity, Muscle. Basic parameters: 3 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other 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

Primary outcome measures

  • variation in "spontaneous/resting" cortico-medullo-radiculo-muscular synchronization before and after selective rhizotomy surgery [Time frame: Day 0]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 2 centers
  • Hpu Lenval — Nice
  • HFAR — Paris

Identifiers

NCT: NCT06281223 · JBR_2023_9

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗