Electrical Stimulation, Stroke
Conditions
Brief summary
The aim of the study is to evaluate effects of current stimulation of the brain on vision parameters, vision-related quality of life, and physiological parameters to uncover mechanisms of vision restoration. These include EEG-spectra and coherence measures, and visual evoked potentials. The design of stimulation protocols involves an appropriate sham-stimulation condition and sufficient follow-up periods to test whether the effects are stable. This is the first application of non-invasive current stimulation for vision rehabilitation in stroke-related visual field deficits.
Interventions
DEVICErepetitive transorbital AC Stimulation
Repetitive transorbital ACS with max 30 Hz, 1,5 mA for 10 days, 20 min/day
DEVICEcombination of transcranial direct current stimulaton and rtACS
Sequential tDCS (anodal occipital stimulation with 2 mA for 20 min/day for 10 days) and rtACS
Sponsors
ERA-NET
University of Magdeburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
randomized, controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* HH due to ischemic or hemorrhagic stroke * age between 18 and 75 years * lesion age at least 6 months * stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded) * presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician * best corrected visual acuity at least 0.4 (20/50 Snellen) or better
Exclusion criteria
* known active malignancy * eye or central nervous system diseases that interfere with the study (including poorly controlled glaucoma) * electric or electronic implants (e.g. heart pacemaker) * metal artifacts in the eyes or head (with the exception of dental prosthesis or shunts) * expected low compliance (e.g. in case of known psychiatric disease, known drug abuse, and dementing syndromes) * epileptic seizure within the last 10 years * use of antiepileptic or sedative drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Size of the visual field | 2 weeks | Mean threshold in standard static perimetry and and detection accuracy in HRP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting EEG power spectra | 2 weeks | EEG measurement using 128 channel |
Countries
Germany
Outcome results
None listed