Repetitive Transorbital Alternating Current Stimulation in Acute Autoimmune Optic Neuritis

NCT ID: NCT03862313

Last Updated: 2021-03-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2019-12-27

Brief Summary

Optic neuritis (ON) is an acute inflammatory, demyelinating attack of the optic nerve that triggers neurodegeneration in the entire visual pathway; translating into visual dysfunction. Currently, no neuroprotective therapy with satisfying evidence can be offered to patients. Repetitive transorbital alternating current stimulation (rtACS) is a methodology applied to electrically stimulate the retina and the optic nerve and is considered having neuroprotective- and restorative potential. The goal of this pilot study is to assess safety, tolerability and preliminary efficacy of rtACS as a treatment to improve visual functional as well as structural retinal outcomes in patients with a first-ever episode of autoimmune acute ON.

Conditions

Acute Autoimmune Inflammatory Optic Neuritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

active-rtACS arm

Active rtACS on 10 consecutive working days, in addition to standard-of-care corticosteroid treatment.

Group Type: EXPERIMENTAL

active-rtACS treatment

Intervention Type: DEVICE

For the active-rtACS treatment arm, a CE-certificated proprietary class IIa medical device will be used to apply transorbital symmetrical rectangular current pulses in bursts (NextWave® 1.1 system; EBS Technologies GmbH, Germany). The stimulation protocol will be patient-individualized, with a stimulation current strength of 125% of the phosphene threshold recorded during 5Hz stimulation and stimulation frequencies between the individual's EEG alpha frequency and their flicker fusion frequency.

sham-rtACS arm

Sham rtACS on 10 consecutive working days, in addition to standard-of-care corticosteroid treatment.

Group Type: SHAM_COMPARATOR

sham-rtACS treatment

Intervention Type: DEVICE

For the sham-rtACS treatment arm, exactly the same medical device, setup, time schedule, etc. will be used as for the patients of the active-rtACS arm. However, sham-treated patients will receive no actual current stimulation during the therapy sessions.

Interventions

active-rtACS treatment

For the active-rtACS treatment arm, a CE-certificated proprietary class IIa medical device will be used to apply transorbital symmetrical rectangular current pulses in bursts (NextWave® 1.1 system; EBS Technologies GmbH, Germany). The stimulation protocol will be patient-individualized, with a stimulation current strength of 125% of the phosphene threshold recorded during 5Hz stimulation and stimulation frequencies between the individual's EEG alpha frequency and their flicker fusion frequency.

Intervention Type: DEVICE

sham-rtACS treatment

For the sham-rtACS treatment arm, exactly the same medical device, setup, time schedule, etc. will be used as for the patients of the active-rtACS arm. However, sham-treated patients will receive no actual current stimulation during the therapy sessions.

Intervention Type: DEVICE

Other Intervention Names

NextWave® 1.1 system, EBS Technologies GmbH, Germany; NextWave® 1.1 system, EBS Technologies GmbH, Germany

Eligibility Criteria

Inclusion Criteria

• Informed Consent as documented by signature
• Participants are capable of giving informed consent
• Participant who have a good knowledge of German (patient information and consent must be understood)
• Patients, presenting with typical signs and symptoms suggestive of a first-ever episode of unilateral acute autoimmune, inflammatory, demyelinating ON, including idiopathic ON and ON suggestive of multiple sclerosis (MS) (typical clinically isolated syndrome, or with an established diagnosis of relapsing-remitting MS according to latest panel criteria and no better explanation)
• Patients with high-contrast visual acuity of ≤ 0.63 (decimal system) corresponding to a LogMAR value of ≥ 0.2 on the affected eye (assessed using a Snellen chart during clinical routine)
• Patients presenting in clinics within 14 days of symptom onset
• In principle 18-50 year old female and male patients may be recruited. However, since the randomization of patients will be controlled for gender and participants will be enrolled one at a time on a continuous basis, the gender might become relevant late in the study (e.g. if the female block has already been fully recruited and only males might still be enrolled).
• Patients are receiving standard-of-care treatment for ON (cortisone therapy)

Exclusion Criteria

• Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
• Patients with a previous clinical history of ON in the respective eye
• Patients with obvious retinal pathology other than that associated with ON
• Patients who are unable to perform the study assessments (e.g. OCT examination) because of a severe nystagmus (repetitive, uncontrolled eye movements causing unsteady fixation)
• Patients with a recent eye surgery
• Patients with known anti-aquaporin-4- or myelin oligodendrocyte glycoprotein- antibody seropositivity
• Patients with contraindications to the class of device under study (for rtACS): implanted electronic devices, metallic artefacts in the head (excluding dentition), epilepsy, brain cancer, pregnancy, breastfeeding, increased intraocular pressure without appropriate treatment, arterial hypertension without appropriate treatment, skin irritations at intended positions of electrodes, cognitive deficits (unable to provide written informed consent or follow the instructions)
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• Participation in another study with investigational drug/device within the 30 days preceding and during the present study
• Previous enrolment into the current study
• Enrolment of the investigator, his/her family members, employees and other dependent persons

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Zürich

OTHER

Sponsor Role: collaborator

Swiss MS Society

UNKNOWN

Sponsor Role: collaborator

Data Management, Clinical Trials Center, Zurich, Switzerland

UNKNOWN

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Lutterotti, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Neuroimmunology and Multiple Sclerosis Research, Department of Neurology, University Hospital Zurich and University of Zurich, Zurich, Switzerland

Locations

Department of Neurology and Department of Ophthalmology, University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

201802353

Identifier Type: -

Identifier Source: org_study_id