Trial document





This trial has been registered retrospectively.
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  DRKS00004252

Trial Description

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Title

Plasticity in prefrontal cortical regions in humans: genetic variation, cellular mechanisms and modulation by means of neurofeedback

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

We assess short- and long-term induction of plasticity in prefrontal brain regions by means of repetitive transcranial magnetic stimulation (rTMS) and neurofeedback as well as the modulation thereof by genetic risk variants of psychosis and cellular features of neurons. This will be investigated in healthy controls to establish a better understanding of those plasticity processes.

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Brief Summary in Scientific Language

In the present project, plasticity in prefrontal circuits will be investigated in three experiments: (a) a genetic association study examining the effects of genome-wide significant common variants for psychosis on modulation of prefrontal circuit plasticity by repetitive transcranial magnetic stimulation (rTMS), (b) an experiment in healthy controls relating prefrontal plasticity to a direct cellular assay of synaptic and glutamatergic function by using neuronally-differentiated induced pluripotent stem cells together with multimodal imaging and rTMS, and (c) an experiment in healthy controls to directly modulate prefrontal circuit (connectivity) features and dependent cognition through real-time-fMRI based neurofeedback. These experiments will identify genetic variants linking prefrontal plasticity and risk for psychosis, establish a cellular model for systems-level plasticity in humans and provide a first cognitive approach to induce plasticity in connected brain circuits relevant for mental disorders.

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Organizational Data

  •   DRKS00004252
  •   2012/08/02
  •   [---]*
  •   yes
  •   Approved
  •   0270.4-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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

  •   haelthy subjects
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Interventions/Observational Groups

  •   Arm 1: Repetitive transcranial magnetic stimulation (rTMS) in healthy controls
    Plasticity induction in prefrontal brain regions by means of rTMS. Modulation of plasticity by genetic risk variants of psychosis.

    Within-subject Design:
    a) Application of rTMS targeted at the dorsolateral prefrontal cortex (dLPFC): Assessment of connectivity and activity during working memory, rest, and behavioral inhibition
    b) like a) but with Sham application
  •   Arm 2: induced pluripotent stem cells (Subsample of arm 1)
    Stem cells will be generated using materials from skin biopsy and later on differentiated to neuronal cells. Those cell markers will then be related to indicators won in arm 1.

  •   Arm 3: Influences on cortical connectivity by means of neurofeedback.
    Subjects will do repeated neurofeedback training sessions to control
    a) DLPFC-Hippocampus connectivity during working memory
    b) Medial PFC-Amygdala connectivity during an emotion paradigm.

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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Single blind
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Find evidence for genetic influence on rTMS induced cortical plasticity and it’s relation to cellular parameters. Activity and connectivity markers obtained from fMRI during working memory, rest, and behavioral inhibition will serve as indicators.

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Secondary Outcome

Establishment of realtime connectivity neurofeedback as well as the necessary training paradigm.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/02/16
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- right handedness, german native speaker
- ability to understand study protocol and give written informed consent

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Exclusion Criteria

- MR exclusion criteria (metal implants, brain surgery, permanent makeup)
- Migration background
- History of epilepsy or psychiatric disorders (also in first grade relatives).

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. Dr. med.  Andreas  Meyer-Lindenberg 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Ms.  Prof. Dr. med.  Marcella  Rietschel 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Dr.  Axel  Schäfer 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Dr.  Axel  Schäfer 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft (SFB636, Teilprojekt B7)
    • Kennedyallee 40
    • 53175  Bonn
    • 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.