Trial document





This trial has been registered retrospectively.
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  DRKS00006084

Trial Description

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Title

Non-invasive electrostimulation of the brain as a treatment of alertness deficits after traumatic brain injury.

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Aim of this project is the testing of a new, non-invasive electrostimulation procedure.
Our goal is to successfully treat patients suffering from alertness deficits after traumatic brain injury.
There will be two groups in this study.
In group 1 all probandes will receive impulses of alternating currents over a total time of minutes per session.
Probandes in group 2 will receive an alleged application of impulses of alternating currents (placebo).

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Brief Summary in Scientific Language

Aim of our scientific research project is the systematical investigation of the influenciability of alertness deficits in patients after traumatic brain injury by means of repetitive, non-invasive electrical brain stimulation.
Besides the direct effect on various parameters of alertness as well as the augmentation of other rehabilitative measures, our focus lies on long term effects of non-invasive electrical brain stimulation.
Target group are patients after accident-associated traumatic brain damage.
A prospective and randomised pilot study will be performed in the Accident and Emergency Clinic Hamburg as well as the University Clinic of Magdeburg.
Primary aim is the improvement of alertness parameters. If this aim is reached a multicentre study including various neurorehabiltation clinics administered by the german social accident insurance is planned.

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Organizational Data

  •   DRKS00006084
  •   2014/10/13
  •   [---]*
  •   yes
  •   Approved
  •   PV 4332, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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

  •   Brain injury
  •   Organic psychosyndrome
  •   S06.0 -  Concussion
  •   S06.9 -  Intracranial injury, unspecified
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Interventions/Observational Groups

  •   The cerebral cortex of the proband is stimulated by means of alternating currents
    in a frequency range from 5 to 30 Hz, with amplitudes between 100–800 µA with a total stimulation time of 20 minutes per session.
    The stimulation decive is the "DC-Stimulator" produced by Neuro Conn.
    The treatment will take place daily (monday to friday) over a two weak period.
  •   The proband receives a pseudo application of alternating currents (placebo).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Aim is the improvement of alertness.
The achievement of this aim will be examined
before and after the stimulation period by means of neuropsychological testing. Stimulation, training and acquisition of the psychometric data will take place every day in the morning and for each proband at the same time of day.
The acquired data will be analysed by means of standardized, computer-based diagnostic test procedures such as TAP (Test of Attentional Performance , ZIMMERMANN & FIMM, 2009, Version 2.2. test modules will be „alertness“; „permanent alertness“ und „divided attention“).




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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
  •   2013/06/28
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Female and male patients suffering traumatic brain injury due to an accident, with evidence of a diffuse-axonal or substantial brain injury by means of mri detection. Inclusion into study as early as one month after the accident.
Age range of patients 18-60 years.

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Exclusion Criteria

Patients with electrical implants or metallic artefacts in the cranial region (exception: dental metall implants), severe or severest organic psychosyndromes, history of seizures, severe visual or hearing deficits, other disorders that could influence the study results such as hemiparesis, neglect or treatment with highly potent neuroleptica.
Further the occurence of complaints succeeding the electrostimulation such as hydrocephalus, seizures oder other serious medical conditions with potential effect on cognitive-mnestic performance (e.g. depression, psychosis).

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Deutsche Gesetzliche Unfallversicherung
    • Mr.  Dr.  M  Schmidt 
    • Alte Heerstrasse 111
    • 53754  St. Augustin
    • Germany
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    •   02241 231-01
    •   [---]*
    •   [---]*
    •   [---]*
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    • Otto-von-Guericke-Universität MagdeburgMedizinische FakultätInstitut für Medizinische Psychologie
    • Mr.  Professor  Bernhard  Sabel 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
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    • Berufsgenossenschaftliches Unfallkrankenhaus Hamburg
    • Mr.  Dr.  Andreas  Gonschorek 
    • Bergedorfer Strasse 10
    • 21033  Hamburg
    • Germany
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    • Berufsgenossenschaftliches Unfallkrankenhaus Hamburg
    • Mr.  Dr.  Andreas  Gonschorek 
    • Bergedorfer Strasse 10
    • 21033  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Gesetzliche Unfallversicherung
    • Mr.  Dr.  M  Schmidt 
    • Alte Heerstrasse 111
    • 53754  St. Augustin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.