Informations générales (source: ClinicalTrials.gov)
Effect of Transorbital Electrical STIMulation of Optic Nerve on Remyelination After an Acute Optic Neuritis (ONSTIM)
Interventional
N/A
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (Voir sur ClinicalTrials)
juillet 2019
juillet 2022
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital La Pitié-Salpêtrière | Celine Louapre | Contact (sur clinicalTrials) | |||
| CHNO DES QUINZE-VINGTS PARIS | Michel PAQUES, PU-PH | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
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