SCT_optnerve: Trial of Alternating Current Stimulation in Optic Neuropathy
Study Details
Study Description
Brief 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. The investigators hypothesized that rtACS would improve visual functions within the defective visual field sectors of the visual field (primary outcome measure).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: rtACS (Verum condition) Repetitive transorbital alternating current stimulation (rtACS) |
Device: 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.
Other Names:
|
| No Intervention: 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) |
Outcome Measures
Primary Outcome Measures
- Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors [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.
Secondary Outcome Measures
- Other Visual and EEG Parameters [Nov 2006 - Dec 2010]
Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.
Eligibility Criteria
Criteria
Inclusion Criteria
-
patients with optic nerve lesion
-
stable visual field defect with residual vision
-
lesion age at least 6 months
Exclusion Criteria
-
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
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Medical Psychology | Magdeburg | Germany | 39120 |
Sponsors and Collaborators
- University of Magdeburg
- EBS Technologies GmbH
Investigators
- Principal Investigator: Bernhard A Sabel, PhD, University of Magdeburg
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- EBS_optnerve_SCT
Study Results
Participant Flow
| Recruitment Details | Assessed for eligibility (n=325)from local institutional database and upon response on announcements in local newspapers from Nov 2006 - Dec 2008. Excluded (n=303): not meeting inclusion criteria (n=248), declined to participate (n=40), other reasons (n=15) |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | rtACS (Verum Condition) | Sham Stimulation (Placebo Condition) |
|---|---|---|
| Arm/Group Description | 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. | 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) |
| Period Title: Overall Study | ||
| STARTED | 12 | 10 |
| COMPLETED | 12 | 10 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | rtACS (Verum Condition) | Sham Stimulation (Placebo Condition) | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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) | Total of all reporting groups |
| Overall Participants | 12 | 10 | 22 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
8
66.7%
|
8
80%
|
16
72.7%
|
| >=65 years |
4
33.3%
|
2
20%
|
6
27.3%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
52.3
(14.3)
|
51.9
(17.3)
|
52.1
(15.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
6
50%
|
3
30%
|
9
40.9%
|
| Male |
6
50%
|
7
70%
|
13
59.1%
|
| Region of Enrollment (participants) [Number] | |||
| Germany |
12
100%
|
10
100%
|
22
100%
|
Outcome Measures
| Title | Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors |
|---|---|
| Description | 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. |
| Time Frame | Outcome measures were assessed at initial diagnostics (baseline) and after 10 days stimulation at post diagnostics |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | rtACS (Verum Condition) | Sham Stimulation (Placebo Condition) |
|---|---|---|
| Arm/Group Description | 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. | 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) |
| Measure Participants | 12 | 10 |
| Mean (Standard Deviation) [percent change] |
24.75
(22.40)
|
39.16
(25.26)
|
| Title | Other Visual and EEG Parameters |
|---|---|
| Description | Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra. |
| Time Frame | Nov 2006 - Dec 2010 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | 1 year | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were cutaneous sensations (tingling) under the stimulation electrodes and temporary sleeping difficulties | |||
| Arm/Group Title | rtACS (Verum Condition) | Sham Stimulation (Placebo Condition) | ||
| Arm/Group Description | 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. | 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) | ||
All Cause Mortality |
||||
| rtACS (Verum Condition) | Sham Stimulation (Placebo Condition) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 0/10 (0%) | ||
Serious Adverse Events |
||||
| rtACS (Verum Condition) | Sham Stimulation (Placebo Condition) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 0/10 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| rtACS (Verum Condition) | Sham Stimulation (Placebo Condition) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/12 (58.3%) | 2/10 (20%) | ||
| Nervous system disorders | ||||
| sleeping difficulties | 2/12 (16.7%) | 2 | 2/10 (20%) | 2 |
| Skin and subcutaneous tissue disorders | ||||
| cutaneous sensation | 5/12 (41.7%) | 5 | 0/10 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Prof. Bernhard A. Sabel |
|---|---|
| Organization | Otto-von-Guericke University of Magdeburg, Medical Faculty, Institute of Medical Psychology, Magdeburg, Germany |
| Phone | 0049 3916721800 |
| bernhard.sabel@med.ovgu.de |
- EBS_optnerve_SCT