Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions
Primary Purpose
Complete Hemianopia, Incomplete Hemianopia, Scotoma
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Verum stimulation
Placebo stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Complete Hemianopia focused on measuring hemianopia, visual field defect, stroke, non-invasive brain stimulation, alternating current stimulation
Eligibility Criteria
Inclusion Criteria:
- lesion of the tractus opticus or of the visual cortex
- lesion age > 6 months
- stable visual field defect with residual vision
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Inst. f. Medical Psychology, Univ. of Magdeburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Verum stimulation
Placebo stimulation
Arm Description
repetitive transorbital alternating current stimulation (rtACS)
compared to verum stimulation the same electrode montage set-up is used during placebo stimulation, except that placebo patients receive a minimal stimulation
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
visual acuity (LogRAD)
EEG parameters
entrainment of stimulation frequencies (EEG power spectra) and measures of functional connectivity
conventional perimetry
visual fields obtained by static and kinetic perimetry (average threshold in db, average excentricity in degrees)
reaction time (ms)
average reaction time in ms, measured by computer-based high resolution perimetry (HRP)
Full Information
NCT ID
NCT01418820
First Posted
August 16, 2011
Last Updated
July 3, 2019
Sponsor
University of Magdeburg
Collaborators
EBS Technologies GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01418820
Brief Title
Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions
Official Title
Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Magdeburg
Collaborators
EBS Technologies GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complete Hemianopia, Incomplete Hemianopia, Scotoma, Quadrantanopia, Stroke, Hemorrhage, Brain Trauma
Keywords
hemianopia, visual field defect, stroke, non-invasive brain stimulation, alternating current stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Verum stimulation
Arm Type
Experimental
Arm Description
repetitive transorbital alternating current stimulation (rtACS)
Arm Title
Placebo stimulation
Arm Type
Sham Comparator
Arm Description
compared to verum stimulation the same electrode montage set-up is used during placebo stimulation, except that placebo patients receive a minimal stimulation
Intervention Type
Device
Intervention Name(s)
Verum stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
detection accuracy (%) in visual field measures over baseline
Description
visual stimuli detection accuracy in residual and absolutely defect visual field will be assessed using computer-based high resolution perimetry (HRP)
Time Frame
baseline to 8 weeks after stimulation
Secondary Outcome Measure Information:
Title
detection accuracy (%) in the intact visual field over baseline
Description
visual stimuli detection accuracy in the intact visual field will be assessed using computer-based high resolution perimetry (HRP)
Time Frame
baseline to 8 weeks after stimulation
Title
visual acuity (LogRAD)
Time Frame
baseline to 8 weeks after stimulation
Title
EEG parameters
Description
entrainment of stimulation frequencies (EEG power spectra) and measures of functional connectivity
Time Frame
baseline to 8 weeks after stimulation
Title
conventional perimetry
Description
visual fields obtained by static and kinetic perimetry (average threshold in db, average excentricity in degrees)
Time Frame
baseline to 8 weeks after stimulation
Title
reaction time (ms)
Description
average reaction time in ms, measured by computer-based high resolution perimetry (HRP)
Time Frame
baseline to 8 weeks after stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lesion of the tractus opticus or of the visual cortex
lesion age > 6 months
stable visual field defect with residual vision
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard A Sabel, Ph.D.
Organizational Affiliation
Univ. of Magdeburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inst. f. Medical Psychology, Univ. of Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
34219679
Citation
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.
Results Reference
derived
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Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions
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