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Non-invasive Current Stimulation for Restoration of Vision

Primary Purpose

Stroke, Electrical Stimulation

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

repetitive transorbital AC Stimulation

combination of transcranial direct current stimulaton and rtACS

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Institute of Medical Psychology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Arm Label

rtACS

tDCS/rtACS

Sham stimulation

Arm Description

repetitive transorbital ACS

Sequential tDCS - tACS

Outcomes

Primary Outcome Measures

Size of the visual field

Mean threshold in standard static perimetry and and detection accuracy in HRP

Secondary Outcome Measures

Resting EEG power spectra

EEG measurement using 128 channel

Full Information

NCT ID

NCT04008589

First Posted

July 3, 2019

Last Updated

November 6, 2020

Sponsor

University of Magdeburg

Collaborators

ERA-NET

1. Study Identification

Unique Protocol Identification Number

NCT04008589

Brief Title

Non-invasive Current Stimulation for Restoration of Vision

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

January 1, 2014 (Actual)

Primary Completion Date

March 31, 2016 (Actual)

Study Completion Date

November 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Magdeburg

Collaborators

ERA-NET

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Electrical Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

randomized, controlled

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rtACS

Arm Type

Experimental

Arm Description

repetitive transorbital ACS

Arm Title

tDCS/rtACS

Arm Type

Experimental

Arm Description

Sequential tDCS - tACS

Arm Title

Sham stimulation

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

repetitive transorbital AC Stimulation

Intervention Description

Repetitive transorbital ACS with max 30 Hz, 1,5 mA for 10 days, 20 min/day

Intervention Type

Device

Intervention Name(s)

combination of transcranial direct current stimulaton and rtACS

Intervention Description

Sequential tDCS (anodal occipital stimulation with 2 mA for 20 min/day for 10 days) and rtACS

Primary Outcome Measure Information:

Title

Size of the visual field

Description

Mean threshold in standard static perimetry and and detection accuracy in HRP

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Resting EEG power spectra

Description

EEG measurement using 128 channel

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Institute of Medical Psychology

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

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Non-invasive Current Stimulation for Restoration of Vision

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