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| Name | Class |
|---|---|
| EBS Technologies GmbH | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rtACS (Verum condition) | Experimental | Repetitive 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive transorbital alternating current stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Outcome measures were assessed at initial diagnostics (baseline) and after 10 days stimulation at post diagnostics |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Nov 2006 - Dec 2010 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bernhard A Sabel, PhD | University of Magdeburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Medical Psychology | Magdeburg | 39120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22124039 | Result | 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. |
| Label | URL |
|---|---|
| Study protocol as submitted (ethical proposal) - link "clinical trials" | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | rtACS (Verum Condition) | Repetitive transorbital alternating current stimulation (rtACS) Repetitive transorbital alternating current stimulation : 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. |
| FG001 | Sham Stimulation (Placebo Condition) | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | rtACS (Verum Condition) | Repetitive transorbital alternating current stimulation (rtACS) Repetitive transorbital alternating current stimulation : 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percent change | Outcome measures were assessed at initial diagnostics (baseline) and after 10 days stimulation at post diagnostics |
|
1 year
Adverse events were cutaneous sensations (tingling) under the stimulation electrodes and temporary sleeping difficulties
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rtACS (Verum Condition) | Repetitive transorbital alternating current stimulation (rtACS) Repetitive transorbital alternating current stimulation : 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cutaneous sensation | Skin and subcutaneous tissue disorders | Systematic Assessment | induced by electric current, felt as tingling |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Bernhard A. Sabel | Otto-von-Guericke University of Magdeburg, Medical Faculty, Institute of Medical Psychology, Magdeburg, Germany | 0049 3916721800 | bernhard.sabel@med.ovgu.de |
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| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D020221 | Optic Nerve Injuries |
| ID | Term |
|---|---|
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D020209 | Cranial Nerve Injuries |
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|
|
| BG001 | Sham Stimulation (Placebo Condition) | 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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sham Stimulation (Placebo Condition) | 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) |
|
|
| Secondary | 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. | Not Posted | Nov 2006 - Dec 2010 | Participants |
| 0 |
| 12 |
| 0 |
| 12 |
| 7 |
| 12 |
| EG001 | Sham Stimulation (Placebo Condition) | 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) | 0 | 10 | 0 | 10 | 2 | 10 |
|
| sleeping difficulties | Nervous system disorders | Systematic Assessment |
|
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |