Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00010907

Trial Description

start of 1:1-Block title

Title

Transcranial Alternating Current Stimulation (tACS) as a Tool to Modulate P300 Amplitude in Attention Deficit Hyperactivity Disorder (ADHD)

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

Trial Acronym

[---]*

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

Main goal of this study was the investigation of the effictivity of trancranial alternating current stimulation (tACS) in Attention-Deficit/Hyperactivity Disorder (ADHD). Primary measure of investigation was the amplitude of average brain activity in response to an oddball stimulus appr. 300 ms after presentation (so-called P300 acitivity) as this amplitude has been shown to be decreased in ADHD patients in comparison to controls. Participants were 18 ADHD patients who were randomly allocated to either a tACS- or a placebo- stimulation group. They performed three blocks of the oddball task: one pre, during and post tACS/placebo block. Alongside a reduction of P300 amplitude pre to post tACS stimulation we hypothesized a reduction in behavioral parameters relevant for ADHD symptomatology, namely reaction time and error rates (omissions and false alarms).

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

Brief Summary in Scientific Language

Studies examining event-related potentials (ERP) in patients affected by attention deficit / hyperactivity disorder (ADHD) have found considerable evidence of reduced target P300 amplitude across different perceptual modalities. P300 amplitude has been related to attention-driven context comparison and resource allocation processes and its alteration in ADHD can be reasonably assumed to be related to ADHD typical cognitive performance deficits. Transcranial alternating current stimulation (tACS) can increase the amplitude of endogenous brain oscillations. Because ERP components can be viewed as event-related oscillations (EROs), with P300 translating into the delta and theta frequency range, an increase of delta and theta ERO amplitudes by tACS should result in an increase of P300 amplitudes in ADHD patients. To test this hypothesis, 18 adult ADHD patients (7 female) performed three consecutive blocks of a visual oddball task while EEG was recorded. Patients received either 20 min of tACS or sham stimulation in the seocnd block. Individual stimulation frequency was determined using a time-frequency decomposition of the P300 of the first block. Our results demonstrate a significant increase in P300 amplitude in the stimulation group which was accompanied by a trend towards decreases in omission errors pre-to-post tACS.

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

Organizational Data

  •   DRKS00010907
  •   2019/06/05
  •   [---]*
  •   yes
  •   Approved
  •   102/2016, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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

  •   F90.0 -  Disturbance of activity and attention
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   20 minutes of transcranial alternating current stimulation (individual stimulation frequency determined via time frequency analysis of P300 activity pre intervention, intensity of stimulation: 1mA), measurement of P300 activity and behavioral variables for comparison: pre and post stimulation.
  •   20 minutes of placebo stimulation (same procedure as in tACS group, stimulator automatically switched of after 1 minute), measurement of P300 activity and behavioral variables for comparison: pre and post stimulation.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Basic research/physiological study
  •   Parallel
  •   [---]*
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

P300 amplitude was defined as the maximum value of the averaged ERP waveform in µV at Pz electrode per block and patient. P300 parameters were derived from pre and post block trials respectively. Indiviual change pre-to-post was then compared between the experimental groups. (2 x 2 design)

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

Secondary Outcome

Response time in ms, defined as time between presentation and button press (instructed for oddball "X" stimuli), averaged over block and patient. 2 types of errors measured in absolute number: Miss when button was not pressed in time window between 200 and 1000ms after "X" presentation, False Alarm when button was pressed in response to "O" stimulus, averaged across block and patient. Group were then compared using individual differences between the block averages. (2 x 3 design)

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

Recruitment

  •   Actual
  •   2017/05/09
  •   30
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

•Age: 18-60
•Emmetropia
•Right-handedness
•German speaking
•ADHD diagnosis based on DSM-V
•Retrospektive perserverence of ADHD symptomatology into adulthood (Wender-Utah-Rating Scale: Retz-Junginger, Retz et al. 2002)
•informed consent

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

Exclusion Criteria

•Magnetizable metal near brain/skull
•Cochlea implants
•Implanted neurostimulator
•Epilepsiy (within previous medical history or family)
•(comorbide) neurologic conditions
•Severe affective disorders/schizophrenia/substance addiciton/autism
•Dermatosis
•Pregnancy
•Medication had to be discontinued at least 3 days prior to the day of measurement
•No other psychopharmacological medication

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Department of Psychology, European Medical SchoolCarl von Ossietzky Universität
    • Mr.  Prof. Dr.  Christoph  Herrmann 
    • Ammerländer Heerstr. 114-118
    • 26129  Oldenburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • University of Bonn, Department of Psychiatry andPsychotherapy
    • Ms.  Univ.-Prof. Dr. med.  Alexandra  Philipsen 
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Department of Psychology, European Medical SchoolCarl von Ossietzky Universität
    • Mr.  Prof. Dr.  Christoph  Herrmann 
    • Ammerländer Heerstr. 114-118
    • 26129  Oldenburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Department of Psychology, European Medical SchoolCarl von Ossietzky Universität
    • Mr.  Prof. Dr.  Christoph  Herrmann 
    • Ammerländer Heerstr. 114-118
    • 26129  Oldenburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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.