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Non-invasive Current Stimulation for Restoration of Vision

NCT ID: NCT04008589

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2020-11-05

Brief Summary

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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

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Conditions

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Stroke Electrical Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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rtACS

repetitive transorbital ACS

Group Type EXPERIMENTAL

repetitive transorbital AC Stimulation

Intervention Type DEVICE

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

combination of transcranial direct current stimulaton and rtACS

Intervention Type DEVICE

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

tDCS/rtACS

Sequential tDCS - tACS

Group Type EXPERIMENTAL

repetitive transorbital AC Stimulation

Intervention Type DEVICE

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

combination of transcranial direct current stimulaton and rtACS

Intervention Type DEVICE

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

Sham stimulation

Group Type SHAM_COMPARATOR

repetitive transorbital AC Stimulation

Intervention Type DEVICE

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

combination of transcranial direct current stimulaton and rtACS

Intervention Type DEVICE

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

Interventions

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repetitive transorbital AC Stimulation

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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ERA-NET

UNKNOWN

Sponsor Role collaborator

University of Magdeburg

OTHER

Sponsor Role lead

Responsible Party

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Bernhard A. Sabel

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Medical Psychology

Magdeburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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REVIS

Identifier Type: -

Identifier Source: org_study_id