Study of Brain-spinal Cord Neural Connectivity in Spasticity

Spasticity, Muscle Clinical Trial

— MOVE  

Official title:

Study of Brain-spinal Cord Neural Connectivity in Spasticity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06281223
• Other study ID #: JBR_2023_9
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: May 2026

Study information

• Verified date: February 2024
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity, Muscle

Intervention

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 and recording take place in the operating room while the patient is under general anaesthetic (intubated and sedated).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0