Complete HemianopiaPhase 2NCT01418820
Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions
A Phase 2 study testing Verum stimulation in people with Complete Hemianopia and Incomplete Hemianopia, run by University of Magdeburg at 1 site in Germany.
Trial summary
Visual field areas, which are not absolutely blind, are hypothesized to have some residual capacities that constitute their potential for vision restoration. Vision restoration can be achieved by varies methods including behavioral training and electrical brain stimulation such as transcranial direct current… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Complete Hemianopia, Incomplete Hemianopia, Scotoma
- What is being tested?
- Verum stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Dec 2013
- Phase
- Phase 2
- 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
- lesion of the tractus opticus or of the visual cortex
- lesion age > 6 months
- stable visual field defect with residual vision
Who cannot join
- electric or electronic implants, e.g. heart pacer
- any metal artefacts in the head
- Epilepsy
- Auto-immune diseases in acute stage
- mental diseases, e.g. schizophrenia etc.
- diabetic retinopathy
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- addictive diseases
- blood pressure above 160/100 mmHg
- instable or high level of intraocular pressure above 27 mmHg
- retinitis pigmentosa
- pathological nystagmus
- presence of an un-operated tumor or tumor relapse (patients with non-progressive tumor are eligible if study participation is recommended by medical authorities)
- focal findings in EEG or photosensitivity (patients with single seizure more than 10 yrs ago may participate)
- recurrent transitional ischemic attacks after stroke
- arteriosclerosis of large blood vessels with stenosis >75%
- severe coronary heart disease (CHD)
- unstable angina pectoris
- diabetes with blood glucose level > 9 mmol/l
- myocard infarct/ cardiomyopathy
- ventricular fibrillation
- risk of vascular thrombosis
- pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
Germany1 site
Inst. f. Medical Psychology, Univ. of Magdeburg
Magdeburg, 39120
About this study
Visual field areas, which are not absolutely blind, are hypothesized to have some residual capacities that constitute their potential for vision restoration. Vision restoration can be achieved by varies methods including behavioral training and electrical brain stimulation such as transcranial direct current stimulation (tDCS) and repetitive transorbital alternating current stimulation (rtACS) which are able to influence the excitability and activity of cortical areas.
It is hypothesized that transorbital alternating current stimulation (tACS) can improve the residual field of vision in patients with post-chiasmatic lesions.
- Conditions
- Complete Hemianopia, Incomplete Hemianopia, Scotoma, Quadrantanopia, Stroke, Hemorrhage
- Being tested
- Verum stimulation, Placebo stimulation
- Keywords
- hemianopia, visual field defect, stroke, non-invasive brain stimulation, alternating current stimulation
- Medical subject headings
- Scotoma, Hemianopsia, Stroke, Hemorrhage, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum stimulationDevice
10 days (2x 5 working days), daily transorbital alternating current stimulation (rtACS) is applied with a device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse is below 1000 µA. Current intensity is individually adjusted according to how well patients perceived phosphenes, e.g. any sensation of flickering light in response to the rtACS stimulation. Stimulation frequencies were between the individual alpha frequency peak and below flicker fusion.
Placebo stimulationDevice
10 days (2x 5 working days), daily sham-stimulation with the same electrode montage set-up that is used for verum transorbital alternating current stimulation (rtACS). Minimal sham-stimulation was performed with single bursts (approx. one per min) of electrical currents at a given frequency of 5Hz and individually adjusted current amplitude.
| Study group | Role | What they receive |
|---|---|---|
| Verum stimulation | Experimental | repetitive transorbital alternating current stimulation (rtACS) Receives: Device: Verum stimulation |
| Placebo stimulation | Sham comparator | compared to verum stimulation the same electrode montage set-up is used during placebo stimulation, except that placebo patients receive a minimal stimulation Receives: Device: Placebo stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection accuracy (%) in visual field measures over baseline
visual stimuli detection accuracy in residual and absolutely defect visual field will be assessed using computer-based high resolution perimetry (HRP)
Measured: baseline to 8 weeks after stimulation
Secondary outcomes (5)
detection accuracy (%) in the intact visual field over baseline
visual stimuli detection accuracy in the intact visual field will be assessed using computer-based high resolution perimetry (HRP)
Measured: baseline to 8 weeks after stimulation
visual acuity (LogRAD)
Measured: baseline to 8 weeks after stimulation
EEG parameters
entrainment of stimulation frequencies (EEG power spectra) and measures of functional connectivity
Measured: baseline to 8 weeks after stimulation
conventional perimetry
visual fields obtained by static and kinetic perimetry (average threshold in db, average excentricity in degrees)
Measured: baseline to 8 weeks after stimulation
reaction time (ms)
average reaction time in ms, measured by computer-based high resolution perimetry (HRP)
Measured: baseline to 8 weeks after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complete HemianopiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 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, Ph.D., Principal investigator, Univ. of Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418820
- Sponsor's protocol ID
- EBS-PP-2011-02-16-001
- Status last verified
- Jul 2019
- First submitted
- 16 Aug 2011
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Raty S, Borrmann C, Granata G, Cardenas-Morales L, Schoenfeld A, Sailer M, Silvennoinen K, Holopainen J, De Rossi F, Antal A, Rossini PM, Tatlisumak T, Sabel BA. Non-invasive electrical brain stimulation for vision restoration after stroke: An exploratory randomized trial (REVIS). Restor Neurol Neurosci. 2021;39(3):221-235. doi: 10.3233/RNN-211198.
PubMed 34219679
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions
- ClinicalTrials.gov ID
- NCT01418820
- Acronym / sponsor ID
- EBS-PP-2011-02-16-001
- Conditions
- Complete Hemianopia, Incomplete Hemianopia, Scotoma, Quadrantanopia, Stroke, Hemorrhage
- Keywords
- hemianopia, visual field defect, stroke, non-invasive brain stimulation, alternating current stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Collaborators
- EBS Technologies GmbH
- Study start
- Mar 2011 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Aug 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.
Visual field areas, which are not absolutely blind, are hypothesized to have some residual capacities that constitute their potential for vision restoration. Vision restoration can be achieved by varies methods including behavioral training and electrical brain stimulation such as transcranial direct current stimulation (tDCS) and repetitive transorbital alternating current stimulation (rtACS) which are able to influence the excitability and activity of cortical areas.
It is hypothesized that transorbital alternating current stimulation (tACS) can improve the residual field of vision in patients with post-chiasmatic lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum stimulation | Experimental | Device: Verum stimulationrepetitive transorbital alternating current stimulation (rtACS) |
| Placebo stimulation | Sham comparator | Device: Placebo stimulationcompared to verum stimulation the same electrode montage set-up is used during placebo stimulation, except that placebo patients receive a minimal stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- lesion of the tractus opticus or of the visual cortex
- lesion age > 6 months
- stable visual field defect with residual vision
Key exclusion criteria (22 listed)
- electric or electronic implants, e.g. heart pacer
- any metal artefacts in the head
- Epilepsy
- Auto-immune diseases in acute stage
- mental diseases, e.g. schizophrenia etc.
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 |
|---|---|---|
| Verum stimulation10 days (2x 5 working days), daily transorbital alternating current stimulation (rtACS) is applied with a device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse is below 1000 µA. Current intensity is individually adjusted according to how well patients perceived phosphenes, e.g. any sensation of flickering light in response to the rtACS stimulation. Stimulation frequencies were between the individual alpha frequency peak and below flicker fusion. | Device | Verum stimulation |
| Placebo stimulation10 days (2x 5 working days), daily sham-stimulation with the same electrode montage set-up that is used for verum transorbital alternating current stimulation (rtACS). Minimal sham-stimulation was performed with single bursts (approx. one per min) of electrical currents at a given frequency of 5Hz and individually adjusted current amplitude. | Device | Placebo stimulation |
Primary outcome
detection accuracy (%) in visual field measures over baseline
Time frame: baseline to 8 weeks after stimulation
visual stimuli detection accuracy in residual and absolutely defect visual field will be assessed using computer-based high resolution perimetry (HRP)
5 secondary outcomes
detection accuracy (%) in the intact visual field over baseline
Time frame: baseline to 8 weeks after stimulation
visual acuity (LogRAD)
Time frame: baseline to 8 weeks after stimulation
EEG parameters
Time frame: baseline to 8 weeks after stimulation
conventional perimetry
Time frame: baseline to 8 weeks after stimulation
reaction time (ms)
Time frame: baseline to 8 weeks 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 5 Jul 2019.
- Derived from this study: PubMed 34219679Raty S, Borrmann C, Granata G, Cardenas-Morales L, Schoenfeld A, Sailer M, Silvennoinen K, Holopainen J, De Rossi F, Antal A, Rossini PM, Tatlisumak T, Sabel BA. Non-invasive electrical brain stimulation for vision restoration after stroke: An exploratory randomized trial (REVIS). Restor Neurol Neurosci. 2021;39(3):221-235. doi: 10.3233/RNN-211198.
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, Ph.D. principal investigator
Univ. of Magdeburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Verum stimulation in people with Complete Hemianopia and Incomplete Hemianopia, 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 22 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 5 Jul 2019. 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (%) in visual field measures over baseline (time frame: baseline to 8 weeks after stimulation). 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 NCT01418820, 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 5 Jul 2019.