Visual ImpairmentNCT01282827
Paraorbital-Occipital Electric Stimulation in Patients With Optic Neuropathy (BCT_optnerve)
A study testing rtACS (verum condition) in people with Visual Impairment, run by University of Magdeburg at 2 sites 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 75 years
- Conditions the study is for
- Visual Impairment
- What is being tested?
- rtACS (verum condition)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2006to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- residual vision
- patients with optic nerv lesion
- lesion age at least 6 months
- stable visual field defect
Who cannot join
- electric or electronic implants such as pace maker
- any metal artefacts in head and truncus
- epilepsia
- photosensitive epilepsy as determines by EEG
- autoimmune illnesses in acute stage
- mental diseases such e.g. schizophrenia etc.
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- diabetes causing diabetic retinopathy
- addiction
- high blood pressure
- unstable or high level intraocular pressure (i.e. > 27 mmHg)
- retinitis pigmentosa
- pathological nystagmus
- presence of an un-operated tumor or tumor recidive
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin
Berlin, 10117
Institut für Medizinische Psychologie, Leipziger Str. 44
Magdeburg, 39120
About this study
Official title: Paraorbital-occipital Alternating Electric Current Stimulation in Patients With Optic Neuropathy
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 with the defective visual field sectors of the visual field (primary outcome measure).
Read the detailed description
exploratory, randomized, controlled study
- Conditions
- Visual Impairment
- Being tested
- rtACS (verum condition), placebo stimulation
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rtACS (verum condition)Device
Also called Device for electrical stimulation "Brainstim", Hersteller: "ELSTIM", St. Petersburg, Russland, Device number: "07062006", Classification: Class II, Type BF
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 1000 microA. 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.
placebo stimulationDevice
Also called Device for electrical stimulation "Brainstim", Hersteller: "ELSTIM", St. Petersburg, Russland, Device number: "07062006", Classification: Class II, Type BF
a clicking sound was presented and the same electrodes montage set-up was used during rtACS and placebo stimulation, except that placebo patients received no current (stimulator turned off).
| Study group | Role | What they receive |
|---|---|---|
| rtACS (Verum condition) | Experimental | Repetitive transorbital alternating current stimulation (rtACS) Receives: Device: rtACS (verum condition) |
| Placebo stimulation | Placebo comparator | no intervention (Sham stimulation) Receives: Device: placebo stimulation |
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 visus 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).
Measured: between baseline and 60 days after stimulation
Secondary outcomes (5)
Visual Parameters 1
DA in static and kinetic perimetry
Measured: baseline to 60 days after stimulation
Visual Parameters 2
reaction time (RT) in HRP
Measured: baseline to 60 days after stimulation
Visual Parameters 3
visual acuity (VA)
Measured: baseline to 60 days after stimulation
Visual Parameters 4
contrast vision
Measured: baseline to 60 days after stimulation
EEG parameters
EEG power spectra
Measured: baseline to 60 days after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startNov 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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, Prof. Dr., Principal investigator, University of Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282827
- Sponsor's protocol ID
- EBS-optnerv-BCT
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2011
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paraorbital-occipital Alternating Electric Current Stimulation in Patients With Optic Neuropathy
- ClinicalTrials.gov ID
- NCT01282827
- Acronym / sponsor ID
- EBS-optnerv-BCT
- Conditions
- Visual Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Collaborators
- EBS Technologies GmbH
- Study start
- Nov 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Not posted in the source record
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 with the defective visual field sectors of the visual field (primary outcome measure).
Detailed description
exploratory, randomized, controlled study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rtACS (Verum condition) | Experimental | Device: rtACS (verum condition)Repetitive transorbital alternating current stimulation (rtACS) |
| Placebo stimulation | Placebo comparator | Device: placebo stimulationno intervention (Sham stimulation) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- residual vision
- patients with optic nerv lesion
- lesion age at least 6 months
- stable visual field defect
Key exclusion criteria (13 listed)
- electric or electronic implants such as pace maker
- any metal artefacts in head and truncus
- epilepsia
- photosensitive epilepsy as determines by EEG
- autoimmune illnesses in acute stage
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 |
|---|---|---|
| rtACS (verum condition)Also: Device for electrical stimulation "Brainstim", Hersteller: "ELSTIM", St. Petersburg, Russland, Device number: "07062006", Classification: Class II, Type BFRepetitive, 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 1000 microA. 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) |
| placebo stimulationAlso: Device for electrical stimulation "Brainstim", Hersteller: "ELSTIM", St. Petersburg, Russland, Device number: "07062006", Classification: Class II, Type BFa clicking sound was presented and the same electrodes montage set-up was used during rtACS and placebo stimulation, except that placebo patients received no current (stimulator turned off). | Device | Placebo stimulation |
Primary outcome
Detection accuracy (DA) change in percent over baseline within defective visual field sectors
Time frame: between baseline and 60 days after stimulation
Central visus 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).
5 secondary outcomes
Visual Parameters 1
Time frame: baseline to 60 days after stimulation
Visual Parameters 2
Time frame: baseline to 60 days after stimulation
Visual Parameters 3
Time frame: baseline to 60 days after stimulation
Visual Parameters 4
Time frame: baseline to 60 days after stimulation
EEG parameters
Time frame: baseline to 60 days after stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
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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, Prof. Dr. principal investigator
University of Magdeburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rtACS (verum condition) in people with Visual Impairment, run by University of Magdeburg at 2 sites 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 4 inclusion and 13 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 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: between baseline and 60 days after stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2021.