Spasticity, MuscleMOVENCT06281223
Study of Brain-spinal Cord Neural Connectivity in Spasticity
An observational study of Spasticity, Muscle, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Spasticity, Muscle
- What is being tested?
- intraoperative neuroelectrophysiological monitoring
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Feb 2024to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with a diagnosis of spasticity requiring selective rhizotomy in neurosurgery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hpu Lenval
Nice, 06200
Aline JOULIE, 04.92.03.05.20, aline.joulie@hpu.lenval.com
Nathalie CHIVORET, MD
- Recruiting
HFAR
Paris, 75019
Pia VAYSSIERE, MD, 01.48.03.77.29, pvayssiere@for.paris
Pia VAYSSIERE, MD
About this study
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
- Being tested
- intraoperative neuroelectrophysiological monitoring
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative neuroelectrophysiological monitoringOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start26 Feb 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity, MuscleStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pia VAYSSIERE, MD, Study director, HFAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281223
- Sponsor's protocol ID
- JBR_2023_9
- Acronym
- MOVE
- Status last verified
- Jun 2025
- First submitted
- 20 Feb 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Brain-spinal Cord Neural Connectivity in Spasticity
- ClinicalTrials.gov ID
- NCT06281223
- Acronym / sponsor ID
- MOVE / JBR_2023_9
- Conditions
- Spasticity, Muscle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with a diagnosis of spasticity requiring selective rhizotomy in neurosurgery.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraoperative neuroelectrophysiological monitoringThe 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). | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pia VAYSSIERE, MD study director
HFAR
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity, Muscle, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation in "spontaneous/resting" cortico-medullo-radiculo-muscular synchronization before and after selective rhizotomy surgery (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.