Status:
UNKNOWN
Effect of Transorbital Electrical STIMulation of Optic Nerve on Remyelination After an Acute Optic Neuritis
Lead Sponsor:
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Collaborating Sponsors:
Fondation ARSEP
APHP
Conditions:
Multiple Sclerosis
Optic Neuritis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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...
Detailed Description
This is a randomized, controlled, prospective, interventional, blinded trial which aims to evaluate the safety and efficacy of transorbital electrical nerve stimulation on remyelination and neuroprote...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04042363
Start Date
July 10 2019
End Date
July 1 2022
Last Update
August 28 2019
Active Locations (2)
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1
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, France, 75012
2
Institut du Cerveau et de la Moelle epiniere - Hopital Pitie Salpetriere
Paris, France