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NCT Number: NCT06281223

Study of Brain-spinal Cord Neural Connectivity in Spasticity

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.

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Key information

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hpu Lenval, Nice, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. variation in "spontaneous/resting" cortico-medullo-radiculo-muscular synchronization before and after selective rhizotomy surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: MOVE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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