Trial document




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  DRKS00019950

Trial Description

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Title

Development-dependent aspects of theta-phase gamma-amplitude coupling and their role in interference control in children with ADHD

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Cognitive skills like for example the suppression of unimportant stimuli or remembering important tasks are accompanied by changes in the electroencephalogram (EEG). An EEG records electrical activity of the brain at rest or during the processing of tasks. It is characterized by an overlap of different frequency components. Interestingly the appearance of fast frequency bands in the EEG is modulated by slower oscillations: the occurrence of high frequency oscillations in the gamma band (from 30 Hz) is directed by the phase of simultaneously occurring oscillations in the theta-band (4-8 Hz). This Theta-Phase Gamma-Amplitude Coupling (TGC) is linked to reception and specific memory- and attention processes. Children with an attention deficit hyperactivity disorder (ADHD) have often deficits regarding working memory and the suppression of responses. The aim of this study is to investigate, if these cognitive deficits in children with ADHD are accompanied by changes of the TGC. Since cognitive Performance usually improves in the course of intellectual development, we also want to examine, if this performance enhancement is related to a maturation of the TGC. Therefore children and adolescents with ADHD, healthy children and adolescents and healthy adults will be examined. The participants in this study complete interference control-, working memory-, and attention tasks, while an EEG is recorded. To examine, if the brain maturation relates to the TGC and the performance in the tasks MRI Scans will also be taken.

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Brief Summary in Scientific Language

This study aims to prove, that pathological cognitive functions are associated with oscillatory brain activity in the gamma- and theta frequency range. Therefore, deficient Inhibition and working memory performance in children with the neurodevelopmental disorder attention deficit hyperactivity disorder (ADHD) and data of healthy children and adolescents and healthy adults will be compared. We expect, that the theta-phase gamma-amplitude coupling (TGC) in cognitive processes is affected by neuronal maturation processes. We furthermore expect that children with ADHD have a divergent TGC in inhibition- and working memory processes due to neuroanatomical maturation deficits.
The TGC is connected to perception, memory- and attentional processes and differentiates between children with ADHD and healthy controls in the resting state EEG. A high TGC during the representation of a stimulus is associated with high memory performance in older adults. However, it is suspected, that TGC is not a specific mechanism in memory, but rather relevant for different cognitive functions. In this study children and adolescents with ADHD, healthy children and healthy adults complete interference control-, working memory-, and attention tasks, while an EEG is recorded. To investigate, if the maturation of the brain is associated with the TGC and the performance in the interference control- and working memory tasks, a resting state fMRI, DTI and structural MRI will also be recorded.
The data of the ADHD patients are collected in the Study E-Stim ADHD CIV-17-09-021424 / DRKS00012659. The data acquisition for the two groups “healthy children and adolescents” and “healthy adults” will be taking place in Kiel at the Klinik für Kinder- und Jugendpsychiatrie und –psychotherapie.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00019950
  •   2019/12/04
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  •   yes
  •   Approved
  •   D 553/19, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   F90 -  Hyperkinetic disorders
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Interventions/Observational Groups

  •   children and adolescents with ADHD: 3 sessions: 1.Informed consent and diagnostics; 2. EEG session with 64 channel EEG during n-back-, flanker- and continuous performance task (CPT); 3. MRI session with structural MRI, diffusion-tensor-imaging (DTI) and functional MRI in resting state (resting state fMRI).
    The Data for Study Arm 1 are collected in the Study E-Stim ADHD CIV-17-09-021424 / DRKS00012659.
  •   healthy children and adolescents: 3 sessions: 1.Informed consent and diagnostics; 2. EEG session with 64 channel EEG during n-back-, flanker- and continuous performance task (CPT); 3. MRI session with structural Magnetic Resonance Imaging (MRI), diffusion-tensor-imaging (DTI) and functional MRI in resting state (resting state fMRI).
  •   healty adults: 3 sessions: 1.Informed consent and diagnostics; 2. EEG session with 64 channel EEG during n-back-, flanker- and continuous performance task (CPT); 3. MRI session with structural Magnetic Resonance Imaging (MRI), diffusion-tensor-imaging (DTI) and functional MRI in resting state (resting state fMRI).
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Characteristics

  •   Non-interventional
  •   Other
  •   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

number of errors, accuracy and reaction times in n-back-, flanker- and continuous performance task; TGC (Theta-Phase Gamma-Amplitude Coupling)

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Secondary Outcome

functional resting state MRI, density of grey and white matter of the cortex in qmm

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/01/06
  •   66
  •   Monocenter trial
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Inclusion Criteria

  •   Both, male and female
  •   10   Years
  •   30   Years
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Additional Inclusion Criteria

Healthy children and adolescents at the age of 10-18, healthy adults at the age of 23-30 and children and adolescents with ADHD at the age of 10-18 years.

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Exclusion Criteria

IQ<80, birthweight < 2500gr., born before the 37th week of pregancy, past or present neurological diseases/brain surgery, history of craniocerebral injury with loss of consciousness, dermatological diseases of the scalp, heart disease, concurrent neurofeedback therapy;
Additional exlusion criteria for participating in the MRI-measurement are metal implants, other unremovable metal objects in or at the body and pregnancy.

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Addresses

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    • Zentrum für Integrative Psychiatrie gGmbH Campus Kiel, Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie
    • Niemannsweg 147
    • 24105  Kiel
    • Germany
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    • Zentrum für Integrative Psychiatrie gGmbH Campus Kiel Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie
    • Ms.  Hannah  Brauer 
    • Niemannsweg 147
    • 24105  Kiel
    • Germany
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    • Zentrum für Integrative Psychiatrie gGmbH Campus Kiel Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie
    • Ms.  Hannah  Brauer 
    • Niemannsweg 147
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Zentrum für Integrative Psychiatrie gGmbH Campus Kiel, Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie
    • Niemannsweg 147
    • 24105  Kiel
    • Germany
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    • European Union Horizon2020 research and innovation program under Grant Agreement number: 731827 (STIPED) ,Directorate-General for Research and Innovation European Commission
    • Rue de la Loi / Wetstraat 170
    • B-1049  Bruxelles
    • Belgium
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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