Trial document





This trial has been registered retrospectively.
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  DRKS00004176

Trial Description

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Title

Markers of global plasticity and response to cognitive training in subjects with mild cognitive impairment.

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Trial Acronym

MCI_TMS_MRI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this study, we aim to test if the brain of subjects with mild cognitive impairment has the same ability of that of healthy controls to adapt to new stimuli. Stimuli will cover a wide range of modalities (e.g. words that have to be learnt, objects that have to be named, etc). We will also employ magnetic stimulation and expose the brain to short electric stimulation to study its ability to adapt.

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Brief Summary in Scientific Language

Correlation of PAS-TMS, VEP-potentiation and slope of learning curve (verbal fluency, naming, etc.) on the basis of genetic markers.

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Organizational Data

  •   DRKS00004176
  •   2012/10/30
  •   [---]*
  •   yes
  •   Approved
  •   227/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   F06.7 -  Mild cognitive disorder
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Patients with mild cognitive disorder: 1.) Repetitive training of naming; verbal fluency; spatial orientation; word learning. Naming, fluency and word learning will be tested using standard tests (e.g. animal names within 1 min). These repetitive training sessions will each only take a few minutes and will be repeated three times over the course of the two study days. Spatial orientation will be tested by testing the ablity to orient in a hospital building. This tast takes a bout 15 min and will be performed twice without break. 2.) Teaching of learning strategies (e.g. association techniques) in a group setting. The groups will hold weekly meetings for 90 minutes over around 2 months.
  •   Healthy controls: All procedures will be performed as in the patient's group except that there will be no training in a group setting.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

What? We plan to correlate the strength of potentiation measured using transcranial magnetic stimulation (TMS) with a paired associative stimulation protocol (PAS-TMS) with a potentiation induced by visually envoked potentials (VEP) measured usign functional magnetic stimulation. When? At the end of the second study day.
How? A single variable results from PAS-TMS and VEP, both reflecting potentiation and plasticity. Those will be correlated.

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Secondary Outcome

What? Correlation between learning and genetics as well as with kognitive markers (e.g. slope of learning curve in naming, fluency, etc.)
When? At the end of second study day and again after 2 months.
How? The slop of the learning curve of each modality will be correlated against each other and against the variables from endpoint 1.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/09/02
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   80   Years
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Additional Inclusion Criteria

Patients: Diagnosis of MCI defined by a Z-score below -1.5 in one of the CERAD domains
Controls: Normal kognitive functioning. Operationalised by Z-scores above -1.

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Exclusion Criteria

Contraindikations against TMS or MRI. Psychoactive medication. Drug abusus. Severe neurological or psychiatric diseases. Age <40 or >80 years.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Abteilung Psychiatrie
    • Mr.  PD Dr.  Stefan  Klöppel 
    • Hauptstrasse 5
    • 79104  Freiburg
    • Germany
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    • Abteilung Psychiatrie
    • Mr.  PD Dr.  Stefan  Klöppel 
    • Hauptstraße 5
    • 79104  Freiburg
    • Germany
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    • Uniklinik Freiburg
    • Ms.  Dipl. Psych.  Jessica  Peter 
    • Breisacher Strasse 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Psychiatrie und Psychotherapie
    • Mr.  PD Dr.  Stefan  Klöppel 
    • Hauptstrasse 5
    • 79104  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.