Study of Brain-spinal Cord Neural Connectivity in Spasticity
ConditionSpasticity, Muscle
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-17
SponsorFondation Ophtalmologique Adolphe de Rothschild
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with a diagnosis of spasticity requiring selective rhizotomy in neurosurgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
intraoperative neuroelectrophysiological monitoring
Other interventionThe 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).
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
variation in "spontaneous/resting" cortico-medullo-radiculo-muscular synchronization before and after selective rhizotomy surgery
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.
Time frame
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Source ClinicalTrials.gov