Study of Brain-spinal Cord Neural Connectivity in Spasticity

NCT06281223 | Recruiting DMC

• 1 other identifier: JBR_2023_9
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Spasticity, Muscle

Outcome Measures

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.

  Day 0

Interventions

intraoperative neuroelectrophysiological monitoring OTHER

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).

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of spasticity requiring selective rhizotomy in neurosurgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (2)

Hpu Lenval

Nice, 06200, France

RECRUITING

HFAR

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pia VAYSSIERE, MD

  HFAR

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: February 26, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)