Transcranial Alternating Current Stimulation (tACS) as a Tool to Modulate P300 Amplitude in Attention Deficit Hyperactivity Disorder (ADHD)
Organizational Data
- DRKS-ID:
- DRKS00010907
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2019-06-05
- Last update in DRKS:
- 2020-05-14
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
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).
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.
Health condition or problem studied
- ICD10:
- F90.0 - Disturbance of activity and attention
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 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.
- Arm 2:
- 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.
Endpoints
- 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)
- 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)
Study Design
- Purpose:
- Basic research/physiological study
- Allocation:
- Randomized controlled study
- Control:
-
- Placebo
- Phase:
- No Entry
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Oldenburg
Recruitment period and number of participants
- Planned study start date:
- 2016-08-15
- Actual study start date:
- 2017-05-09
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2018-12-31
- Target Sample Size:
- 30
- Final Sample Size:
- 18
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 60 Years
- 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
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
Addresses
Primary Sponsor
- Address:
- Department of Psychology, European Medical SchoolCarl von Ossietzky UniversitätProf. Dr. Christoph HerrmannAmmerländer Heerstr. 114-11826129 OldenburgGermany
- Telephone:
- 0441 798 4936
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-oldenburg.de/allgemeine-psychologie/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Department of Psychology, European Medical SchoolCarl von Ossietzky UniversitätProf. Dr. Christoph HerrmannAmmerländer Heerstr. 114-11826129 OldenburgGermany
- Telephone:
- 0441 798 4936
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-oldenburg.de/allgemeine-psychologie/
Contact for Public Queries
- Address:
- Department of Psychology, European Medical SchoolCarl von Ossietzky UniversitätProf. Dr. Christoph HerrmannAmmerländer Heerstr. 114-11826129 OldenburgGermany
- Telephone:
- 0441 798 4936
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-oldenburg.de/allgemeine-psychologie/
Principal Investigator
- Address:
- Department of Psychology, European Medical SchoolCarl von Ossietzky UniversitätProf. Dr. Christoph HerrmannAmmerländer Heerstr. 114-11826129 OldenburgGermany
- Telephone:
- 0441 798 4936
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-oldenburg.de/allgemeine-psychologie/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Deutsche ForschungsgemeinschaftKennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dfg.de
Ethics Committee
Address Ethics Committee
- Address:
- Geschäftsstelle der medizinischen Ethikkommission, Fakultät VI Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg, Gebäude V04 (Raum 1-137)Ammerländer Heerstraße 14026129 OldenburgGermany
- Telephone:
- +49-441-7983109
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2016-06-20
- Ethics committee number:
- 102/2016
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-01-23
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Publication URL
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry