Study of Brain-spinal Cord Neural Connectivity in Spasticity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-26

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Physiologic Studies of Spasticity

NCT00014976

Muscle Spasticity Healthy

COMPLETED

Probing Neural Circuitry for the Control of Movement

NCT02150642

Neurological Movement Disorders

COMPLETED

Phenotypes, Biomarkers and Pathophysiology in Hereditary Spastic Paraplegias and Related Disorders

NCT03981276

Hereditary Spastic Paraplegia

RECRUITING

SDR Monitoring in Children With Cerebral Palsy

NCT03079362

Cerebral Palsy

COMPLETED

Transcranial Magnetic Stimulation and Electrical Stimulation of Nerves to Study Focal Dystonia

NCT00050024

Dystonic Disorders

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spasticity, Muscle

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No