Effect of Transorbital Electrical STIMulation of Optic Nerve on Remyelination After an Acute Optic Neuritis (ONSTIM)
Multiple Sclerosis, Optic Neuritis
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, optic neuritis, transorbital stimulation, remyelination, nervous system disease, peripheral nervous system disease, optic nerve disease, adaptive optic
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsRecruiting
- Institut du Cerveau et de la Moelle epiniere - Hopital Pitie SalpetriereRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active Transorbital electrical stimulation
Sham Transorbital stimulation
Transorbital electrical stimulation of the optic nerve - 10 sessions during 2 consecutive weeks
Sham stimulation - 10 sessions during 2 consecutive weeks