Status unknownNot a drug-phase studyRelapsing MSNCT04042363

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Transorbital electrical stimulation (Eyetronic Next Wave 1.1)

Placebo or sham

  • Transorbital electrical stimulation (Eyetronic Next Wave 1.1) - Sham stimulation

What it measured

Main measures

  • P100 latency (VEP) after treatment

    24 weeks

    Myelin repair

Other measures (7)

  • Change of P100 amplitude (VEP) after treatment

    24 weeks

    Myelin repair
  • Change of P100 latency and amplitude (VEP) after treatment

    12 and 48 weeks

    Myelin repair
  • Evolution of macular volume after treatment

    12, 24 and 48 weeks

    Retina scans (OCT)
  • Change of mean and temporal Retinal Nerve Fiber Layer (RNFL) thickness and average thickness of macular ganglion cell layer after treatment

    12, 24 and 48 weeks

    Retina scans (OCT)
  • Change of average thickness of macular ganglion cell layer after treatment

    12, 24 and 48 weeks

    Retina scans (OCT)
  • Change of mean deflection of visual field 24-2 after treatment

    12, 24 and 48 weeks

  • Occurrence of adverse events related or not to the stimulation

    through study completion, an average of 3 years

    Safety

Who could take part

Relapsing MS · 18 to 60

Inclusion Criteria: * For MS patients: * Age between 18 and 60 years old. * Relapsing Remitting MS (criteria of McDonald 2017) evolving for less than 10 years or Clinically Isolated Syndrome (CIS)-MS with criteria of spatial dissemination on MRI * Subject presenting an acute unilateral episode of optic neuritis treated optimally (bolus of corticosteroids and plasma exchanges if considered necessary) * Last medical treatment for optic neuritis received between 30 and 90 days before inclusion * Visual acuity \<7/10 of the affected eye at the time of inclusion * Social security scheme or beneficiary of such a scheme For Healthy Volunteers: * Age between 18 and 60 years old. * No history of neurological or ophthalmological diseases * Corrected visual acuity ≥ 8/10 * Scheme or beneficiary of such a scheme Exclusion Criteria: For patients: * Differential diagnosis of Optic neuritis: i) Atypical acute optic neuritis (papillitis, severe papilledema, initial optic atrophy) ii) Optic neuromyelitis iii) Normal VEP during the inclusion visit iv) No detection of VEP during the inclusion visit * Impossibility to perform MRI, MEG, or electrical stimulation: Pacemaker or neurosensory stimulator or implantable defibrillator Clip on an aneurysm or clip on a vascular malformation of the brain Cochlear implants Ocular or cerebral ferromagnetic foreign bodies Metal prostheses or metal clips or splinters Ventriculoperitoneal neurosurgical bypass valves Permanent makeup of the eyelids or lips Black tattoo, important and close to the cranio-facial sphere. Copper Intrauterine Device Person with proven claustrophobia Epilepsy Brain tumor Intraocular pressure without specific treatment Hypertension without treatment Acute retinal hemorrhage Periorbital skin irritation Significant cognitive deficit Known gadolinium allergy * Person with severe or uncontrolled symptoms of kidney, liver, hematological, gastrointestinal, pulmonary or cardiac disease or any uncontrolled intercurrent disease at the time of inclusion. * Pregnant or breath-feeding woman. * Refusal of the participant to be informed in case of fortuitous discoveries having a direct impact on his health and requiring appropriate care * person under judicial protection or deprived of liberty For healthy volunteers: * Contraindication to MRI or MEG * Person with severe or uncontrolled symptoms of kidney, liver, hematological disease, gastrointestinal, pulmonary or cardiac disease or any uncontrolled intercurrent pathology at the time of inclusion. * Pregnant or breath-feeding woman. * Refusal of the participant to be informed in case of fortuitous discoveries having a direct impact on his health and requiring appropriate care * Person under the protection of justice or deprived of liberty

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

In light of experimental models showing that neuronal electrical activity is crucial for the remyelination process, we hypothesize that maintenance of electrical axonal activity in the early stages of optic neuritis may promote myelin repair, limiting thereby axonal degeneration. In humans, electrical stimulation of the optic nerve has been tested mainly in ischemic neuropathy and retinitis pigmentosa, which are both associated with severe axonal/retinal pathology and poor visual prognosis. In contrast, the inflammation of the optic nerve in optic neuritis is generally transient, with less severe axonal damage at the acute phase, which would allow for better efficacy of electrical stimulation as a strategy to promote remyelination and neuroprotection.In light of experimental models showing that neuronal electrical activity is crucial for the remyelination process, we hypothesize that maintenance of electrical axonal activity in the early stages of optic neuritis may promote myelin repair, limiting thereby axonal degeneration. In humans, electrical stimulation of the optic nerve has been tested mainly in ischemic neuropathy and retinitis pigmentosa, which are both associated with severe axonal/retinal pathology and poor visual prognosis. In contrast, the inflammation of the optic nerve in optic neuritis is generally transient, with less severe axonal damage at the acute phase, which would allow for better efficacy of electrical stimulation as a strategy to promote remyelination and neuroprotection.

Papers

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    History

      1. Started

        Jul 2019

      2. Main results due

        Jul 2021

      3. Finished

        Jul 2022

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