Trial document

drksid header


Trial Description

start of 1:1-Block title


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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ytACS cognition

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial


end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011364
  •   2016/11/23
  •   [---]*
  •   yes
  •   Approved
  •   603-16, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F20.0 -  Paranoid schizophrenia
  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
end of 1:N-Block indications
start of 1:N-Block interventions

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.
end of 1:N-Block interventions
start of 1:1-Block design


  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Crossover
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment


  •   Actual
  •   2016/12/05
  •   168
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses


end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

end of 1:n-Block material support
start of 1:1-Block state


  •   Recruiting complete, follow-up complete
  •   2018/05/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.