Brief description of trial (Data source: BASEC)
Diese prospektive, randomisierte, scheinkontrollierte Pilotstudie wird an der Klinik für Neurologie in der Abteilung Neuroimmunologie und Multiple Sklerose (MS) Forschung des Universitätsspitals Zürich (USZ) durchgeführt. Patienten mit einer erstmaligen, akuten autoimmunvermittelten Sehnerventzündung werden nach dem Zufallsprinzip in eine Experimentalgruppe (Stimulationstherapie) oder Kontrollgruppe (Scheintherapie) zugeteilt (12-15 Patienten pro Gruppe). Patienten der Experimentalgruppe erhalten eine repetitive transorbitale Wechselstromtherapie um die Netzhaut und den Sehnerven gezielt zu stimulieren, während Patienten der Kontrollgruppe lediglich mit einer Scheintherapie (ohne Strom) behandelt werden. Die Therapie wird an zehn aufeinanderfolgenden Werktagen durchgeführt und dauert jeweils ungefähr eine Stunde. Zudem erhalten alle Patienten, unabhängig von der Gruppenzuteilung, die empfohlene Standardbehandlung mit Methylprednisolon. Die gesamte Studie dauert für den einzelnen Patienten 4 Monate und umfasst circa 16 Termine im Studienzentrum.
Mit geeigneten Untersuchungsmethoden wie beispielweise der optischen Kohärenztomographie (OCT) oder visuellen Funktionsmessungen (Sehschärfe) sollen in erster Linie präliminäre Daten zur Wirksamkeit dieser Therapie generiert werden. Die gewonnen Daten sollen für die Planung einer grösseren zukünftigen Studie zur Wirksamkeit dieser Therapie genutzt werden. Zudem sollen die Sicherheit und Verträglichkeit dieses elektrischen Stimulationsverfahrens bei Patienten mit einer akuten Sehnerventzündung untersucht werden.
Health conditions investigated(Data source: BASEC)
Autoimmunvermittelte akute Sehnerventzündung (Optikusneuritis). Die untersuchte Krankheit ist eng mit dem Auftreten der Multiplen Sklerose (MS) verknüpft.
Health conditions
(Data source: WHO)
Acute Autoimmune Inflammatory Optic Neuritis
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Nicht-invasive Stimulationstherapie der Netzhaut und des Sehnerven mittels repetitiver transorbitaler Wechselstromstimulation (wiederholt über das äussere Auge applizierte leichte Wechselstromimpulse). Sie wird an zehn aufeinanderfolgenden Arbeitstagen durchgeführt und dauert jeweils inklusive Vorbereitung ungefähr 1.5-2 Stunden.
Interventions
(Data source: WHO)
Device: active-rtACS treatment;Device: sham-rtACS treatment
Criteria for participation in trial
(Data source: BASEC)
• Patienten mit einer ersten einseitigen autoimmunvermittelten akuten Sehnerventzündung
• Das Auftreten von Erstsymptomen durch die Sehnerventzündung innerhalb der letzten 14 Tage
• Patienten, die der empfohlenen Standardbehandlung mit Methylprednisolon zustimmen
Exclusion criteria
(Data source: BASEC)
• Patienten mit einer Sehnerventzündung in der Vorgeschichte
• Patienten mit Kontraindikationen für die elektrische Stimulationstherapie: Implantierte elektronische Geräte (z.B. Herzschrittmacher), metallische Artefakte im oder am Kopf (ausgenommen Zahnersatz), Epilepsie, bösartiger Hirntumor, nichteingestellter erhöhter Augeninnendruck, Schwangerschaft, Stillzeit, nichteingestellter arterieller Bluthochdruck, akute Netzhautblutung, Hautirritationen an den vorgesehenen Positionen der Filzelektroden, kognitive Defizite (Einverständniserklärung kann nicht verstanden werden oder unfähig den Anweisungen zu folgen)
• Patienten mit Diagnose oder Verdacht auf eine andere Sehnerv- oder Netzhauterkrankung
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
Participants fulfilling all of the following inclusion criteria are eligible for the study:
- 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:
The presence of any one of the following exclusion criteria will lead to exclusion of the
participant:
- Patient without legal capacity who is unable to understand the nature, significance
and consequences of the trial
- Women who are pregnant or have the intention to become pregnant during the course of
the study (For women who can get pregnant, pregnancy will be omitted using a pregnancy
test when checking for inclusion and exclusion criteria. Patients will be informed
that they must use contraception during the study)
- 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
-
Further information on trial
Date trial registered
Feb 14, 2019
Incorporation of the first participant
Oct 14, 2019
Recruitment status
Terminated
Academic title
(Data source: WHO)
Assessing Repetitive Transorbital Alternating Current Stimulation in Acute Autoimmune Inflammatory Optic Neuritis Using the NextWave® 1.1 System: A Prospective, Randomized, Patient-blinded, Sham-controlled Pilot Study
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
The primary safety outcome measure will be the total number of adverse events during the entire study period;The primary structural outcome measure will be the mean change in macular ganglion cell and inner plexiform layer thickness [µm] of the affected ON eye at 16 weeks in comparison to baseline of the unaffected contralateral NON eye (pre-treatment).;The primary functional outcome measure will be low-contrast visual acuity [LogMAR] at 16 weeks (3 month follow-up) in ON eyes.
Secundary end point
(Data source: WHO)
Low-contrast visual acuity [LogMAR] at 4 (post-treatment) weeks in ON eyes.;The mean change in macular ganglion cell and inner plexiform layer thickness [µm] of the affected ON eye at 4 weeks in comparison to baseline of the unaffected contralateral NON eye (pre-treatment).;High-contrast visual acuity [LogMAR] at 16 weeks (3 month follow-up) in ON eyes.;High-contrast visual acuity [LogMAR] at 4 weeks (post-treatment) in ON eyes.;Colour vision [tritan] at 16 weeks (3 month follow-up) in ON eyes.;Colour vision [tritan] at 4 weeks (post-treatment) in ON eyes.;Visual field testing [dB] at 16 weeks (3 month follow-up) in ON eyes.;Visual field testing [dB] at 4 weeks (post-treatment) in ON eyes.;Recovery of pattern-reversal visual evoked potential conduction velocity of the affected optic nerve [ms] compared to the intra-individual baseline of the unaffected optic nerve at 16 weeks (3 month follow-up).;Patient-reported vision-related quality of life assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) at 16 weeks (3 month follow-up).;Patient-reported vision-related quality of life assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) at 4 weeks (post-treatment).;The mean change in peripapillary retinal nerve fibre layer (pRNFL) thickness [µm] of the affected ON eye at 16 weeks (3 month follow-up) in comparison to baseline of the contralateral NON eye.;The mean change in peripapillary retinal nerve fibre layer (pRNFL) thickness [µm] of the affected ON eye at 4 weeks (post-treatment) in comparison to baseline of the contralateral NON eye.;The mean change in macular inner nuclear layer (INL) thickness [µm] of the affected ON eye at 16 weeks (3 month follow-up) in comparison to baseline of the contralateral NON eye.;The mean change in macular inner nuclear layer (INL) thickness [µm] of the affected ON eye at 4 (post-treatment) weeks in comparison to baseline of the contralateral NON eye.
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Zurich
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof. Dr. med. Andreas Lutterotti
+41 (0)44 255 49 84
Andreas.Lutterotti@usz.ch
Contact for general information
(Data source: WHO)
Andreas Lutterotti, Prof. Dr. med.
Neuroimmunology and Multiple Sclerosis Research, Department of Neurology, University Hospital Zurich and University of Zurich, Zurich, Switzerland
Contact for scientific information
(Data source: WHO)
Andreas Lutterotti, Prof. Dr. med.
Neuroimmunology and Multiple Sclerosis Research, Department of Neurology, University Hospital Zurich and University of Zurich, Zurich, Switzerland
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
07.02.2019
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2018-02353
Secondary ID (Data source: WHO)
201802353
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