Trial document




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  DRKS00016734

Trial Description

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Title

Data analysis of routine diagnostic data of speech testing before and after awake surgeries

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Trial Acronym

ReDaRoDi

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Intraoperative monitoring is used in patients with brain lesions. Most of them are tumors. In intraoperative speech monitoring awake brain surgery is performed on the patient. The patient carries out several linguistic tasks (test battery), which means that the language-relevant brain areas can be determined selectively. The aim is to use this method to preserve the linguistic functions as far as possible.
The study aims to determine the sensitivity of the test battery and to contribute to the optimization of the test battery, taking current literature into account. For this purpose, the routine diagnostic values of the Aphasie-Schnell-Test (German Version of the Frenchay Aphasia Screening Test) ​​before and after the operation should be compared. The data were collected from June 2008 to January 2019. Based on the literature and the lack of a standardized test battery for the German-speaking countries, it is hypothesized that optimization of the test battery is possible.

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Brief Summary in Scientific Language

Review of the sensitivity of the linguistic test battery in awake craniotomies using pre- and post-operative routine diagnostic values.

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Organizational Data

  •   DRKS00016734
  •   2019/03/05
  •   [---]*
  •   yes
  •   Approved
  •   2019-14083, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   R47.0 -  Dysphasia and aphasia
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Interventions/Observational Groups

  •   Evaluation of patients' routinely collected diagnostic scores before and after intraoperative speech mapping.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Changes of test values of the AST (Aphasie-Schnell-Test) before and after awake surgery

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/02/07
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- carried out awake surgery
- AST-testing pre- and post-operatively carried out
- German as native language
- OP between June 2008 and January 2019

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Exclusion Criteria

- analphabetism
- discontinuation of the awake surgery

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Addresses

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    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin Mainz, Institut für Physikalische Therapie, Prävention und Rehabilitation
    • Mr.  Dr. phil.  Jürgen  Konradi 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin MainzInstitut für Physikalische Therapie, Prävention und Rehabilitation
    • Mr.  Dr. phil.  Jürgen  Konradi 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin MainzInstitut für Physikalische Therapie, Prävention und Rehabilitation
    • Mr.  Dr. phil.  Jürgen  Konradi 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/04/30
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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.