Trial document




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  DRKS00011364

Trial Description

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Title

Effects of transcranial gamma alternating current stimulation (ytACS) in patients with schizophrenia, depression, and in healthy controls

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Trial Acronym

ytACS cognition

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URL of the Trial

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Brief Summary in Lay Language

Transcranial alternating current stimulation (tACS) is a new non-invasive brain stimulation technique. With a frequency of 40 Hz (gamma-frequency, y) it improves attention and working memory in healthy volunteers. In this study, effects of one active ytACS is compared to one sham stimulation. 44 depressed patients and 44 patients with schizophrenia as well as 80 healthy controls are included.

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Brief Summary in Scientific Language

The non invasive brain stimulation technique, transcranial alternating current stimulation (tACS), with a freuency of 40 Hz (gamma frequency, ytACS) is applied once as active stimulation and once as sham stimulation in clinically stable patients with depression and schizophrenia as well as in healthy controls to investigate effects on cognitive processes (attention, working memory). On a pathophysiological level we assume a reduced activity in the left prefrontal cortex in depressed and schizophrenia patients, resulting in lack of impetus, cognitive symptoms, and with the linkage to cortico-limbic structures also in mood disorder. ytACS of the respective area is supposed to enhance neuronal activity resulting in increased cognitive control. ytACS is supposed to increase diminished oscillation activity in this area.

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Organizational Data

  •   DRKS00011364
  •   2016/11/23
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  •   yes
  •   Approved
  •   603-16, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   F20.0 -  Paranoid schizophrenia
  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   Baseline: cognitive test battery with Attention Network Test, n-back-test, trail making test, d2 test, VLMT.
    Intervention: single active ytACS (40 Hz, -1 to +1 mA, range 2 mA, 48000 cycles, i.e. 20 min). Electrode Position: F3/F4.
    Primary endpoint: Change in cognitive tests.
  •   Baseline: cognitive test battery with Attention Network Test, n-back-test, trail making test, d2 test, VLMT.
    Intervention: single sham ytACS (no current flow over 20 min). Electrode Position: F3/F4.
    Primary endpoint: Change in cognitive tests.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Crossover
  •   N/A
  •   No
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Primary Outcome

Improvement in cognition after one active stimulation compared to sham stimulation in trail making test, TMT; D2 test; verbal learning and memory test, VLMT; n-back-test; Regensburg word fluency test, RWT

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Secondary Outcome

profile of side effects of ytACS, shown by the Comfort Rating Questionnaire (CRQ) between active and sham stimulation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/12/05
  •   168
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Diagnosis of schizophrenia or depression, both with stable medication; no psychiatric diagnosis for healthy controls

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Exclusion Criteria

pregnancy, lactation, metal implants in the head (except teeth)

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Addresses

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Sources of Monetary or Material Support

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Status

  •   Recruiting complete, follow-up complete
  •   2018/05/31
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Trial Publications, Results and other Documents

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