Effect of Transorbital Electrical STIMulation of Optic Nerve on Remyelination After an Acute Optic Neuritis
ONSTIM
2 other identifiers
interventional
45
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-sclerosis
Started Jul 2019
Typical duration for not_applicable multiple-sclerosis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2019
CompletedFirst Submitted
Initial submission to the registry
July 16, 2019
CompletedFirst Posted
Study publicly available on registry
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedAugust 28, 2019
July 1, 2019
2 years
July 16, 2019
August 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
P100 latency (VEP) after treatment
Modification of the latency of P100 wave measured by Visual Evoked Potential (VEP) after 24 weeks of treatment with electrical or sham stimulation.
24 weeks
Secondary Outcomes (7)
Change of P100 amplitude (VEP) after treatment
24 weeks
Change of P100 latency and amplitude (VEP) after treatment
12 and 48 weeks
Evolution of macular volume after treatment
12, 24 and 48 weeks
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
Change of average thickness of macular ganglion cell layer after treatment
12, 24 and 48 weeks
- +2 more secondary outcomes
Study Arms (2)
Active Transorbital electrical stimulation
EXPERIMENTALTransorbital electrical stimulation of the optic nerve - 10 sessions during 2 consecutive weeks
Sham Transorbital stimulation
SHAM COMPARATORSham stimulation - 10 sessions during 2 consecutive weeks
Interventions
Calibration phase: The patient will use a response button to indicate the threshold from which he feels a luminous sensation (phosphene). In a second step, he will use the same answer button to indicate the stimulation frequency from which the phosphenes become continuous. Stimulation phase: From these 2 parameters (amplitude and frequency), the stimulation session will begin for a duration of approximately 40 to 50 minutes, the settings being dependent of the individual thresholds.
The calibration phase is identical to the active stimulation. During the stimulation phase, the operator will manually interrupt the stimulation 60 seconds after the start of the session.
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- For patients:
- Differential diagnosis of Optic neuritis:
- 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
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingtslead
- Fondation ARSEPcollaborator
- APHPcollaborator
Study Sites (2)
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75012, France
Institut du Cerveau et de la Moelle epiniere - Hopital Pitie Salpetriere
Paris, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Céline Louapre
Institut du Cerveau et de la Moelle Epiniere, Pitie Salpetriere Hospital, Paris
- PRINCIPAL INVESTIGATOR
Saddek Mohand-Said
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Patients as well as ophthalmologists will be subject to the procedure of masking and will keep the blinding for the duration of the study. As a result, ophthalmologists examiners will not perform electrical stimulation sessions. The persons in charge of the stimulation will be in "open label" and will ensure the inclusion, the follow-up of the patient throughout the study, the stimulation (SHAM or stimulation), the clinical and neurological examination as well as the collection of the treatments and the notification of the Adverse Events/Serious Adverse Events (AE/SAE).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2019
First Posted
August 1, 2019
Study Start
July 10, 2019
Primary Completion
July 1, 2021
Study Completion
July 1, 2022
Last Updated
August 28, 2019
Record last verified: 2019-07