Trial document





This trial has been registered retrospectively.
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  DRKS00012695

Trial Description

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Title

Hemianopia in children: evaluation of adaptive mechanisms as a basis for rehabilitation and for analysis of structure-function relations for the prediction and control of visual functions in brain surgery

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Trial Acronym

HeKiRe

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Lesions of the visual pathways above the optic nerve crossing lead to a visual field defect on the same side of both eyes (homonymous hemianopia). The most common causes in children are brain damage during birth, further stroke, brain tumor, or a consequence of brain surgery, especially after epilepsy surgery. Hemianopia causes severe disability in everyday life, mainly in spatial orientation. There is a large deficit in specific diagnostic methods, and an urgent need for methods of vision rehabilitation programs in these children.
This study for the first time offers the chance to:
1. to examine the relations between imaging and actual visual field loss;
2. to examine spontaneous compensatory eye movement strategies in children with hemianopia of different origin and duration of disease.
3. to evaluate the efficacy and clinical application of a compensatory training method (by search eye movements) to improve orientation.
4. to examine preoperative and postoperative visual function after brain surgery due to epilepsy and tumors in order to make better predictions about a surgery- induced brain damage in the future and to acquire information about adaptations to the visual field loss.
Due to the complexity of the primary disease and the serious damage to the children, the research project is not only of great scientific importance, but also with regard to the patient-oriented implementation, since it uses rehabilitation measures specifically with the ultimate goal of enabling the children to participate in life.

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Brief Summary in Scientific Language

Suprachiasmal lesions of the visual pathways lead to homonymous visual field defects. The most common causes in children are pre- or perinatally acquired brain damage, further stroke, brain tumor, or a consequence of brain surgery, especially after epilepsy surgery. Hemianopia causes severe disability in everyday life, mainly in spatial orientation. There is a large deficit in specific diagnostic methods, and an urgent need for methods of vision rehabilitation programs in these children.
This study for the first time offers the chance to:
1. to examine structure-function relations (brain imaging vs. actual visual field loss);
2. to examine spontaneous compensatory eye movement strategies in children with hemianopia of different genesis and duration of disease.
3. to evaluate the efficacy and clinical application of a compensatory training method (explorative saccadic training) to improve orientation.
4. to examine pre- and postoperative visual function after brain surgery due to epilepsy and tumors in order to make better predictions about a surgery- induced brain damage in the future and to acquire information about adaptations to the visual field loss.
Due to the complexity of the primary disease and the serious damage to the children, the research project is not only of great scientific importance, but also with regard to the patient-oriented implementation, since it uses rehabilitation measures specifically with the ultimate goal of enabling the children to participate in life.

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Organizational Data

  •   DRKS00012695
  •   2017/07/18
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  •   yes
  •   Approved
  •   227/2014BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   H53.4 -  Visual field defects
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Interventions/Observational Groups

  •   All children train at home on their computer with a saccadic training software, which was specially developed for children.
    The saccadic training consists of search tasks with symbols suitable for children.
    The children train at home for 6 weeks, 15
    minutes twice a day, 5 days per week.
    The difficulty level increases every two weeks.
  •   Healthy, age-matched control children will be examined to determine normal values for search times and scanning eye movement behavior during saccadic training, table test and eye tracking. The measurements are carried out on two examination days. The control children do not receive any training.
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Characteristics

  •   Interventional
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  •   Other
  •   Blinded
  •   assessor, data analyst
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

1.Establishment of structure-function relationships between lesions of visual pathway and / or visual cortex and visual field loss by means of evaluation of MRI images at initial examination.
2. To assess adaptive mechanisms in children with hemianopia before training (T1), directly after training (T2) and 6 weeks after end of training (T3):
a) Neuro-ophthalmological examination at T1
b) examination of the visual field at T1
c) Measurement of search times during saccadic training by the Software at start and end of training (between T1 and T2)
d) Measurement of search times during infrared eye tracking, free viewing and search tasks at T1, T2 and T3.
e) Measurement of search times in the "Table Test", in which search tasks with real objects are performed on a table at T1, T2 and T3
f) Quality of life Questionnaires: KINDL®, IVI_C, CVAQC-25 at T1, T2 and T3

3. Another aim of the study is the development and evaluation of a saccadic training program for children with hemianopia before and during the training

4. A further aim is not only to investigate children with long-lasting hemianopia, but also to investigate children with acute-induced hemianopia (in the context of epilepsy-surgical procedures or after tumor surgery) to assess the time course of the visual field loss and the development of compensatory mechanisms.

PS: due to a small number of patients in point 4, this point will be further examinated in a follow-up study.

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Secondary Outcome

None

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/10/22
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   6   Years
  •   19   Years
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Additional Inclusion Criteria

Age between 6-19;
Presence of MRI findings;
Suspected or definitive diagnosis of homonymous hemianopia oder quadrantanopia;
Consent from at least one parent

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Exclusion Criteria

Inadequate cooperation

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Addresses

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    • Forschungseinheit für Visuelle Rehabilitation,Department für Augenheilkunde,Universitäsklinikum Tübingen
    • Ms.  Prof. Dr. med.  Susanne  Trauzettel-Klosinski 
    • Elfriede-Aulhorn-Str.7
    • 72076  Tübingen
    • Germany
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    • Schön Klinik Vogtareuth,Fachklinik für Neuropädiatrie
    • Mr.  Prof. Dr. med.  Martin  Staudt 
    • Krankenhausstraße 20
    • 83569  Vogtareuth
    • Germany
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    • Abteilung für Experimentelle Pädiatrische NeurobildgebungUniversitäts-KinderklinikAbt. III (Neuropädiatrie)
    • Mr.  Prof. Dr. med.  Marko  Wilke 
    • Hoppe-Seyler-Str. 1
    • 72076  Tübingen
    • Germany
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    • Forschungseinheit für Visuelle Rehabilitation,Department für Augenheilkunde,Universitäsklinikum Tübingen
    • Ms.  Prof. Dr. med.  Susanne  Trauzettel-Klosinski 
    • Elfriede-Aulhorn-Str.7
    • 72076  Tübingen
    • Germany
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    • Forschungseinheit für Visuelle Rehabilitation,Department für Augenheilkunde,Universitäsklinikum Tübingen
    • Ms.  Prof. Dr. med.  Susanne  Trauzettel-Klosinski 
    • Elfriede-Aulhorn-Str.7
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Brunenbusch-Stein-Stiftung zur Förderung der medizinischen Forschung
    • Barkhovenallee 1
    • 45239   Essen
    • Germany
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    • Herbert Funke StiftungGemeinnützige Stiftung für Sehbehinderten-Förderung
    • Mariendorfer Damm 60
    • 12109   Berlin
    • Germany
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    • Tistou & Charlotte Kerstan Stiftung
    • Jasminweg 23
    • 72076   Tübingen
    • Germany
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    • Werner Kossmann Stiftung für Lebenshilfe
    • 72764   Reutlingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/01/25
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Trial Publications, Results and other Documents

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