Clinical trial NCT01418820: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Complete Hemianopia
Incomplete Hemianopia
Scotoma
Quadrantanopia
Stroke
Hemorrhage
Brain Trauma
Keywords: hemianopia
visual field defect
stroke
non-invasive brain stimulation
alternating current stimulation
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
Collaborators: name: EBS Technologies GmbH
First posted: 2011-08-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: detection accuracy (%) in visual field measures over baseline
timeFrame: baseline to 8 weeks after stimulation
Secondary outcomes:
measure: detection accuracy (%) in the intact visual field over baseline
timeFrame: baseline to 8 weeks after stimulation
measure: visual acuity (LogRAD)
timeFrame: baseline to 8 weeks after stimulation
measure: EEG parameters
timeFrame: baseline to 8 weeks after stimulation
measure: conventional perimetry
timeFrame: baseline to 8 weeks after stimulation
measure: reaction time (ms)
timeFrame: baseline to 8 weeks after stimulation
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Inst. f. Medical Psychology, Univ. of Magdeburg
Study officials:
affiliation: Univ. of Magdeburg
name: Bernhard A Sabel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.