Non-invasive Current Stimulation for Restoration of Vision

Non-invasive Current Stimulation for Restoration of Vision (REVIS) After Unilateral Occipital Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Electrical Stimulation
• Intervention / Treatment: Device: repetitive transorbital AC Stimulation; Device: combination of transcranial direct current stimulaton and rtACS

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Magdeburg, Germany, 39120
    • Institute of Medical Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham stimulation	Device: repetitive transorbital AC Stimulation; Repetitive transorbital ACS with max 30 Hz, 1,5 mA for 10 days, 20 min/day; Device: combination of transcranial direct current stimulaton and rtACS; Sequential tDCS (anodal occipital stimulation with 2 mA for 20 min/day for 10 days) and rtACS
Experimental: rtACS; repetitive transorbital ACS	Device: repetitive transorbital AC Stimulation; Repetitive transorbital ACS with max 30 Hz, 1,5 mA for 10 days, 20 min/day; Device: combination of transcranial direct current stimulaton and rtACS; Sequential tDCS (anodal occipital stimulation with 2 mA for 20 min/day for 10 days) and rtACS
Experimental: tDCS/rtACS; Sequential tDCS - tACS	Device: repetitive transorbital AC Stimulation; Repetitive transorbital ACS with max 30 Hz, 1,5 mA for 10 days, 20 min/day; Device: combination of transcranial direct current stimulaton and rtACS; Sequential tDCS (anodal occipital stimulation with 2 mA for 20 min/day for 10 days) and rtACS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of the visual field	Mean threshold in standard static perimetry and and detection accuracy in HRP	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting EEG power spectra	EEG measurement using 128 channel	2 weeks

Collaborators and Investigators

• Sponsor: University of Magdeburg
• Collaborators: ERA-NET

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): March 31, 2016
• Study Completion (Actual): November 5, 2020

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: REVIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Research data will be avalaible without restriction
• IPD Sharing Time Frame: After the publication of the data
• IPD Sharing Access Criteria: Contact to the PI
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No