Non-invasive Current Stimulation for Restoration of Vision

Phase 1

Completed

• Conditions: Stroke; Electrical Stimulation
• Interventions: Device: repetitive transorbital AC Stimulation; Device: combination of transcranial direct current stimulaton and rtACS

• Registration Number: NCT04008589
• Lead Sponsor: University of Magdeburg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2016-03-31
• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-05
• Status Verified: 2020-11
• Study Completion: 2020-11-05
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rtACS	combination of transcranial direct current stimulaton and rtACS	repetitive transorbital ACS
tDCS/rtACS	repetitive transorbital AC Stimulation	Sequential tDCS - tACS
tDCS/rtACS	combination of transcranial direct current stimulaton and rtACS	Sequential tDCS - tACS
Sham stimulation	combination of transcranial direct current stimulaton and rtACS	-
rtACS	repetitive transorbital AC Stimulation	repetitive transorbital ACS
Sham stimulation	repetitive transorbital AC Stimulation	-

Primary Outcome Measures

Name	Time	Method
Size of the visual field	2 weeks	Mean threshold in standard static perimetry and and detection accuracy in HRP

Secondary Outcome Measures

Name	Time	Method
Resting EEG power spectra	2 weeks	EEG measurement using 128 channel

Trial Locations

Locations (1)

Institute of Medical Psychology; 🇩🇪 Magdeburg, Germany