Non-invasive Current Stimulation for Restoration of Vision

University of Magdeburg

Status and phase: Completed; Phase 2; Phase 1

Conditions: Electrical Stimulation; Stroke

Treatments: Device: repetitive transorbital AC Stimulation; Device: combination of transcranial direct current stimulaton and rtACS

Study type: Interventional

Funder types: Other

Identifiers

NCT04008589

REVIS

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

rtACS

Experimental group

Description:

repetitive transorbital ACS

Treatment:

Device: combination of transcranial direct current stimulaton and rtACS

Device: repetitive transorbital AC Stimulation

tDCS/rtACS

Experimental group

Description:

Sequential tDCS - tACS

Treatment:

Device: combination of transcranial direct current stimulaton and rtACS

Device: repetitive transorbital AC Stimulation

Sham stimulation

Sham Comparator group

Treatment:

Device: combination of transcranial direct current stimulaton and rtACS

Device: repetitive transorbital AC Stimulation