Trial document





This trial has been registered retrospectively.
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  DRKS00005949

Trial Description

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Title

Electrical stimulation for Restoration of Vision after stroke (REVIS) in the damaged visual field after stroke

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Trial Acronym

REVIS

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URL of the Trial

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Brief Summary in Lay Language

About 1/3 of all stroke patients suffer posterior artery infarction which is detrimental to the brain vision processing centers. This Ieads to serious visual impairment typically in one half of the visual space
(called hemianopia) with significant impairments in every day life activities. The visual loss creates problems with reading, orientation in space and visually-guided mobility, especially driving which remain with the patients for the rest of their lives. New treatments options are therefore urgently needed to help these patients improve their sight. The prevalence of visual impairments in stroke is about 11.0 Mio. worldwide, with 2.1 Mio new cases annually.
Recent studies have shown that there is justifiable hope that we might be able to improve
visual functions . This is based on the presence of residual visual capacities of the brain which are not sufficiently activated. According to the "residual vision activation theory", residual visual tissue is located next to the lesioned area and in larger scale brain networks. By repetitively stimulating them it might be possible to improve vision. This is possible because of the brains ability to adapt to the damage, called "neuroplasticity".
We wish to find the best possible Stimulation methods to activate residual vision by inducing
brain plasticity. This will be accomplished by using modern non-invasive brain Stimulation technology which was already successfully used to improve vision after optic nerve trauma and motor performance deficits after strake. Four European research centres now combine their efforts to better understand the underlying neuronal mechanisms of brain plasticity and to find appropriate means to restore vision after stroke. lf successful, the project will uncover the potential to activate residual visual capacities after stroke and provide the basis for the commercial development of a novel, non-invasive current stimulation medical device. ln this manner many patients can be offered a solution to improve their vision in a Iasting way and thus improve their quality of life. lf the studies are successful, we expect that the new technology can be deployed to routine care of patients with visual impairment
after stroke.
The first Method is the so-called repetitive transorbital alternating current stimulation ( rtACS), ie a non-invasive alternating current stimulation, which has been successfully used for the reduction of visual field defects in individuals with damage to the optic nerve. The second Method is a combined application of rtACS with a direct current stimulation ( transcranial direct current stimulation , tDCS ) of the visual center.

The second Method is a combined application of rtACS with a direct current stimulation ( transcranial direct current stimulation , tDCS ) of the visual center. 3 The control pacing occurs at lower power levels. While it is believed that the first two of these electrical stimulation techniques have a positive influence on the performance in the area of the damaged visual field , it is not supposed for the control stimulation. Whether the patient is one of the two electrical stimulation method or the control treatment gets decided by a computerized random. The probability of obtaining one of the two electric stimulation method is , 67%. Regardless of the type of the method, the stimulation with repeated daily for 10 consecutive business days.

For the objective extraction of study data, it is necessary that neither the patient nor the diagnosticians know which method he receives. After completion of the examination of the patient is informed about the method he has received.




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Brief Summary in Scientific Language

Posterior artery stroke Ieads to serious visual impairments in 1/3 of all stroke patients (2.1 Mio cases annually). Therapies to restore vision are therefore urgently needed to improve quality of life and reduce health-related costs. We now propose to study visual system plasticity and evaluate the effects of a new non-invasive current brain stimulation method to achieve vision restoration.
Residual vision and plasticity rearrangements of the visual system will be studied in patients and cats with posterior hemispheric infarcts. To this end we (i) first characterise visual dysfunctions and identify regions of residual vision, (ii) document signs of plasticity (e.g. receptive field reorganization, local activation and Iong-range connectivity changes), and (iii) attempt to modulate/enhance plasticity with non-invasive brain stimulation (alternative current (AC) applied transorbitally or direct current (DC) applied transcranially). Specifically, we will Iook for signs of local plasticity (receptive field and activation changes as documented by high resolution 7T fMRI and psychophysics experiments) and global plasticity, i.e. inter-hemispheric connectivity (resting state EEG/MEG and TMS-EEG connectivity tests) in patients and in cats before and after brain current Stimulation to check if plasticity was modulated in the right direction to achieve vision restoration.
lf successful we will have a better understanding of vision plasticity after strake and have established non-invasive brain stimulation as a new tool to improve visual functions, thereby
enhancing vision-related quality of life and participation in daily life. Our industry partner will implement the utilized technology to make it safely usable in routine clinical care. This is the first concerted effort to study the role of "global" and "local" mechanisms of visual systems plasticity in vision restoration in a series of clinical experiments using highly sophisticated technologies (which include connectivity studies using neurophysiological techniques such as resting state EEG/MEG, and high resolution 3T and 7T structural & functional MRI). lt is also the "first-ever study" in stroke using non-invasive brain stimulation as a means of driving brain plasticity towards vision restoration.

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Organizational Data

  •   DRKS00005949
  •   2016/06/01
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  •   yes
  •   Approved
  •   173/13, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1154-6947 
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Health Condition or Problem studied

  •   Electrical stimulation for Restoration of Vision after stroke (REVIS) in the damaged visual field after stroke
  •   H53.4 -  Visual field defects
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Interventions/Observational Groups

  •   1.rtACS * (active RTACs - sham tDCS , 30min daily, 10days ): The first treatment group receives the electrical stimulation at supra -orbital electrode placement and is treated with rtACS. The electrode assembly for tDCS ** is also , however, it is applied only initial current , which is then attenuated gradually.
    Electrical stimulation treatment is always carried out with a customized current that is perceived by the subjects as a not unpleasant. At the beginning and at the end of daily treatment , the systolic and diastolic blood pressure and the heart rate are recorded. When you have high blood pressure ( > 160/100 mmHg ), no treatment. Brain waves are derived using EEG addition. Likewise, potential side effects be obtained daily.


    * rtACs - transorbital alternating current stimulation **tDCS - Transcranial direct current simulation
  •   2.rtACS*+ tDCS** (active rtACS - active tDCS , 30min daily, 10days ): The second treatment group receives as both a rtACS ( inhibitory ) transcranial direct current stimulation at 1 mA over the intact hemisphere.

    Electrical stimulation treatment is always carried out with a customized current that is perceived by the subjects as a not unpleasant. At the beginning and at the end of daily treatment , the systolic and diastolic blood pressure and the heart rate are recorded. When you have high blood pressure ( > 160/100 mmHg ), no treatment. Brain waves are derived using EEG addition. Likewise, potential side effects be obtained daily.


    * rtACS - transorbital alternating current stimulation **tDCS - Transcranial direct current simulation
  •   3.Sham ( sham RTACs * - sham tDCS ** , 30min daily, 10days ) : The third group is a control group of subjects who were treated only with sham stimulation. For this purpose, a single pulse stimulation rtACS* done with about 1 current pulse per minute , and a just initial tDCS** as in group 1 The minimum treatment of the control group that allows all subjects can perceive phosphenes , what with a no treatment control group (no stimulation -> no phosphenes) would not be possible. In addition to (quiet) acoustic signals simulate a flow of current. These acoustic signals are given in the electrical stimulation group.

    Electrical stimulation treatment is always carried out with a customized current that is perceived by the subjects as a not unpleasant. At the beginning and at the end of daily treatment , the systolic and diastolic blood pressure and the heart rate are recorded. When you have high blood pressure ( > 160/100 mmHg ), no treatment. Brain waves are derived using EEG addition. Likewise, potential side effects be obtained daily.

    * rtACS - transorbital alternating current stimulation **tDCS - Transcranial direct current simulation
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

increase acuity in the visual field test (High Resolution Perimetry, HRP)

to weeks after the beginning of treatment

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Secondary Outcome

reaction time HRP (High Risk Perimetrie) in ms, increase in mean threshold as parameter of coventionel perimetry,

EEG-power spectrum (electroencephalogram-power spectrum), reading test (International reading Speed texts - IRest)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/03/03
  •   45
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

Prerequisite for participation in the study is a postchiasmatische lesion of the visual pathway with resultant unilateral visual field defect ( Quadrantenanopsie , hemianopia ) after ischemic or hemorrhagic stroke in persons aged 18 to 75 years.
For all participants in the study, the postchiasmatische lesion must be at least 6 months old. The visual field defect must be in the comparison of screening and baseline survey to be stable for so that any possible visual field improvements can be clearly attributed to the stimulation and not to a spontaneous recovery of visual acuity or spontaneous fluctuations in performance.

The study participants have residual visual performance and typically a gradual transition between the blind area ( visual field loss ) and the intact area of the visual field. The corrected visual acuity in each eye of the participant at least 0.4 ( logMAR ) or 20 /50 ( Snellen ).

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Exclusion Criteria

Only subjects included in the study which do not fulfill any of the following exclusion criteria : active malignant tumors , diseases of the eyes or of the central nervous system that interfere with the study ( also includes uncontrolled glaucoma ) , electrical or electronic implants (eg pacemakers) ; metallic artifacts in the eye or the head ( with the exception of dental prostheses and shunts) ; expected low compliance ( for example, as a result of psychiatric or alcohol disorder or dementia syndrome); epilepsy disease within the last 10 years , intake of antiepileptic drugs or sedatives ; are pregnant or breastfeeding women.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Medizinische Psychologie
    • Mr.  Prof. Dr.  Bernhard  Sabel 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Institut Für medizinische Psychologie
    • Ms.  Dr.  Carolin  Gall 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Otto-von-Guericke-Universität MagdeburgInstitut für Medizinische Psychologie
    • Ms.  Dr.  Carolin  Gall 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und ForschungDienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/02/02
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.