Optic Nerve DiseasesSCT_optnerveNCT01270126
Trial of Alternating Current Stimulation in Optic Neuropathy
A study testing Repetitive transorbital alternating current stimulation in people with Optic Nerve Diseases and Optic Nerve Injuries, run by University of Magdeburg at 1 site in Germany.
Trial summary
Non-invasive brain stimulation can increase cortical excitability in the visual system, but it is not known if this is of clinical value. The investigators now assessed if repetitive, transcranial alternating current stimulation (rtACS) can improve visual field size in patients with optic nerve damage. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Optic Nerve Diseases, Optic Nerve Injuries, Optic Neuropathies
- What is being tested?
- Repetitive transorbital alternating current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2006to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with optic nerve lesion
- stable visual field defect with residual vision
- lesion age at least 6 months
Who cannot join
- heart pacemakers and any metal artefacts in head and truncus
- epileptic seizure within the last 3 years
- photosensitive epilepsy as determined by EEG
- mental diseases (schizophrenia etc.)
- unstable diabetes, diabetes causing diabetic retinopathy
- macular degeneration, maculopathy with decimal visual acuity below 0.4
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- high blood pressure
- instable or high level of intraocular pressure (i.e. >27 mmHg)
- presence of an un-operated tumor anywhere in the body
- total blindness
- primary or secondary glaucoma
- pathological nystagmus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Patients With Optic Neuropathy Using Transorbital Alternating Current Stimulation - a Randomized Trial
Non-invasive brain stimulation can increase cortical excitability in the visual system, but it is not known if this is of clinical value. The investigators now assessed if repetitive, transcranial alternating current stimulation (rtACS) can improve visual field size in patients with optic nerve damage. The investigators hypothesized that rtACS would improve visual functions within the defective visual field sectors of the visual field (primary outcome measure).
Read the detailed description
In a prospective, double-blind, randomized, placebo-controlled clinical trial 22 patients with optic nerve damage were randomly assigned to a rtACS- (n=12) or placebo-group (n=10). Visual field measures, visual acuity and EEG-recordings were collected before and after a daily 20-40min treatment for 10-days and at a 2-months-follow-up. Primary outcome measure was detection accuracy (DA) in defective visual field sectors of computer-based high resolution perimetry (HRP). Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.
- Being tested
- Repetitive transorbital alternating current stimulation
- Keywords
- optic neuropathy, alternating current stimulation, vision recovery, restoration, plasticity
- Medical subject headings
- Optic Nerve Diseases, Optic Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transorbital alternating current stimulationDevice
Also called EBS Alpha Synch
Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation.
| Study group | Role | What they receive |
|---|---|---|
| rtACS (Verum condition) | Experimental | Repetitive transorbital alternating current stimulation (rtACS) Receives: Device: Repetitive transorbital alternating current stimulation |
| Sham stimulation (placebo condition) | No intervention | A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors
Central visual fields were assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field were characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors was defined as the primary outcome criterion.
Measured: Outcome measures were assessed at initial diagnostics (baseline) and after 10 days stimulation at post diagnostics
Secondary outcomes (1)
Other Visual and EEG Parameters
Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.
Measured: Nov 2006 - Dec 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startNov 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Optic Nerve DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Collaborators
- EBS Technologies GmbH
- Responsible party
- Principal investigator, Bernhard A. Sabel, University of Magdeburg
- Investigators
- Bernhard A Sabel, PhD, Principal investigator, University of Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270126
- Sponsor's protocol ID
- EBS_optnerve_SCT
- Acronym
- SCT_optnerve
- Status last verified
- Dec 2013
- First submitted
- 3 Jan 2011
- Last updated
- 9 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Sabel BA, Fedorov AB, Naue N, Borrmann A, Herrmann C, Gall C. Non-invasive alternating current stimulation improves vision in optic neuropathy. Restor Neurol Neurosci. 2011;29(6):493-505. doi: 10.3233/RNN-2011-0624.
PubMed 22124039
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Optic Neuropathy Using Transorbital Alternating Current Stimulation - a Randomized Trial
- ClinicalTrials.gov ID
- NCT01270126
- Acronym / sponsor ID
- SCT_optnerve / EBS_optnerve_SCT
- Keywords
- optic neuropathy, alternating current stimulation, vision recovery, restoration, plasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Collaborators
- EBS Technologies GmbH
- Study start
- Nov 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Posted 4 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-invasive brain stimulation can increase cortical excitability in the visual system, but it is not known if this is of clinical value. The investigators now assessed if repetitive, transcranial alternating current stimulation (rtACS) can improve visual field size in patients with optic nerve damage. The investigators hypothesized that rtACS would improve visual functions within the defective visual field sectors of the visual field (primary outcome measure).
Detailed description
In a prospective, double-blind, randomized, placebo-controlled clinical trial 22 patients with optic nerve damage were randomly assigned to a rtACS- (n=12) or placebo-group (n=10). Visual field measures, visual acuity and EEG-recordings were collected before and after a daily 20-40min treatment for 10-days and at a 2-months-follow-up. Primary outcome measure was detection accuracy (DA) in defective visual field sectors of computer-based high resolution perimetry (HRP). Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rtACS (Verum condition) | Experimental | Device: Repetitive transorbital alternating current stimulationRepetitive transorbital alternating current stimulation (rtACS) |
| Sham stimulation (placebo condition) | No intervention | –A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with optic nerve lesion
- stable visual field defect with residual vision
- lesion age at least 6 months
Key exclusion criteria (12 listed)
- heart pacemakers and any metal artefacts in head and truncus
- epileptic seizure within the last 3 years
- photosensitive epilepsy as determined by EEG
- mental diseases (schizophrenia etc.)
- unstable diabetes, diabetes causing diabetic retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive transorbital alternating current stimulationAlso: EBS Alpha SynchRepetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation. | Device | rtACS (Verum condition) |
Primary outcome
Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors
Time frame: Outcome measures were assessed at initial diagnostics (baseline) and after 10 days stimulation at post diagnostics
Central visual fields were assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field were characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors was defined as the primary outcome criterion.
1 secondary outcome
Other Visual and EEG Parameters
Time frame: Nov 2006 - Dec 2010
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22124039Sabel BA, Fedorov AB, Naue N, Borrmann A, Herrmann C, Gall C. Non-invasive alternating current stimulation improves vision in optic neuropathy. Restor Neurol Neurosci. 2011;29(6):493-505. doi: 10.3233/RNN-2011-0624.
- Study protocol as submitted (ethical proposal) - link "clinical trials"Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard A Sabel, PhD principal investigator
University of Magdeburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transorbital alternating current stimulation in people with Optic Nerve Diseases and Optic Nerve Injuries, run by University of Magdeburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors (time frame: Outcome measures were assessed at initial diagnostics (baseline) and after 10 days stimulation at post diagnostics). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01270126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.