P300 modulation via transcranial alternating current stimulation in patients with attention deficit/hyperactivity disorder (ADHD)
Organizational Data
- DRKS-ID:
- DRKS00020828
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-05-04
- Last update in DRKS:
- 2023-02-14
- Registration type:
- Prospective
Acronym/abbreviation of the study
P300-TACS
URL of the study
https://www.attention-projekt.de/
Brief summary in lay language
ADHD treatment in adults usually consists of drug and/or psychotherapeutic treatment, whereby the drug treatment success is usually higher than the psychotherapeutic treatment success. However, a drug-based ADHD treatment often leads to undesired side effects and must be closely monitored. The development of further, effective ADHD therapy approaches with few side effects therefore seems urgently indicated. The aim of the BMBF-funded project ATTENTION (= Mobile system for ADHD therapy using transcranial electrical neurostimulation) is the development of a novel medical-technical system for the targeted neuromodulation of attention-associated cortical networks by means of electrical stimulation. Specifically, a demonstrator will be developed with which attention-relevant EEG signals can be extracted and modulated by electrostimulation. Prior to this, this study will test whether neuromodulation by the brain stimulation method leads to attention enhancement in ADHD patients.
Brief summary in scientific language
Attention deficit hyperactivity disorder (ADHD) in adulthood is a common mental disorder with massive psychosocial and health-economical effects. ADHD treatment in adults usually consists of psychopharmacotherapeutic and/or psychotherapeutic treatment, whereby the psychopharma-cotherapeutic treatment success is usually higher than the psychotherapeutic treatment success. However, psychopharmacotherapeutic ADHD treatment often leads to undesirable side effects and must be closely monitored by physicians. In addition, in about 30% a psychopharmacothera-peutic treatment shows no effect or an intolerance. The development of further effective ADHD therapies with few side effects is therefore urgently indicated. Various studies analyzing data recorded by electroencephalography (EEG) examined event-related potentials (EKPs) in adult patients with ADHD and found a reduced P300 amplitude and prolonged latency compared to healthy subjects. Since P300 studies generally assume a connection between P300 amplitude and attention allocation, as well as between P300 latency and stimulus processing speed, an increase in P300 amplitude and a reduction in latency seems to be a promising therapeutic approach. Transcranial alternating current stimulation (tACS), a non-invasive brain stimulation technique, can increase the amplitude of endogenous brain oscillations. EKPs can be understood as event-related oscillations. The P300 component can thus be regarded as part of an oscillation in the delta (0-4Hz) to theta (4-8Hz) frequency range. The aim of the study is to increase the P300 amplitude in adult ADHD patients using tACS. In particular, the question that needs to be answered is whether, and if so, to what extent a tACS-based neuromodulation of attention-associated oscillatory networks (especially the delta rhythm and the P300 EKP component) leads to an improvement in attention in ADHD patients.
Health condition or problem studied
- ICD10:
- F90 - Hyperkinetic disorders
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- ADHD-Patients; Intervention vs. control-intervention (tACS-stimulation vs. Sham-stimulation). Each intervention will last approximately 60 minutes. With preparation and follow-up, a session will last no longer than 3 hours. The conditions (stimulation/sham) will be randomized so that one half of the ADHD patients will first receive the tACS-stimulation and the other half will first receive the sham-stimulation. In the second session, the conditions are then adjusted accordingly.
- Arm 2:
- Due to the limitations of the Corona pandemic, it was decided to conduct the study exclusively with ADHD patients and not to further include healthy controls for now.
Endpoints
- Primary outcome:
- Increase of the P300 amplitude by tACS (Measured by frequency analysis in the EEG).
- Secondary outcome:
- Improvement of attention performance (reaction times, omission and commission errors). Brain activity is measured by EEG before, during and after the interventions. The electrostimulation or sham stimulation will be applied with the help of a certified electrostimulator. The parameters for attention performance are measured by a visual oddball task (Comparison between before and after the intervention).
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Placebo
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Crossover
- 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):
-
- Medical center Klinik und Poliklinik für Psychiatrie und Psychotherapie Bonn
Recruitment period and number of participants
- Planned study start date:
- 2020-06-01
- Actual study start date:
- 2020-07-28
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2021-08-12
- Target Sample Size:
- 25
- Final Sample Size:
- 22
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 50 Years
- Additional Inclusion Criteria:
- Fulfilment of the diagnostic criteria for ADHD according to DSM-5 criteria, age between 18-50 years, normal or corrected vision, right-handed
Exclusion Criteria
Serious psychiatric disorders such as schizophrenia and/or affective disorders, antisocial personality disorder, current alcohol or drug addiction, serious organic diseases, epilepsy, seizure disorders (epilepsy) in the family, skin diseases/open spots on the head, metal in the brain/skull area, pregnancy, insufficient command of the German language
Addresses
Primary Sponsor
- Address:
- Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum BonnProf. Dr. Alexandra PhilipsenVenusberg Campus 153127 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukbonn.de/42256BC8002AF3E7/direct/startseite-npp
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum BonnDr. Niclas BraunVenusberg Campus 153127 BonnGermany
- Telephone:
- 022828731374
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ukbonn.de/42256BC8002AF3E7/direct/virtual-reality-therapy-and-psychophysiology
Contact for Public Queries
- Address:
- Uniklinikum BonnKyra KannenVenusberg Campus 153127 BonnGermany
- Telephone:
- 022828731291
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum BonnDr. Niclas BraunVenusberg Campus 153127 BonnGermany
- Telephone:
- 022828731374
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ukbonn.de/42256BC8002AF3E7/direct/virtual-reality-therapy-and-psychophysiology
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:
- Bundesministerium für Bildung und Forschung Dienstsitz BerlinFriedrichstraße 130 B10117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bmbf.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission Medizinische Fakultät BonnVenusberg Campus 1, Geb. 0253105 BonnGermany
- Telephone:
- +49-228-28751282
- Fax:
- +49-228-28751932
- 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:
- 2019-10-01
- Ethics committee number:
- 357/19
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-01-08
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?:
- Yes
- IPD Sharing Plan:
- The raw data will be provided by the authors, without inadequate reservations, 6 month after publication. On request, these will be made available to any qualified researcher.
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:
- Kannen, K., Aslan, B., Boetzel, C., Herrmann, C. S., Lux, S., Rosen, H., Selaskowski, B., Wiebe, A., Philipsen, A., & Braun, N. (2022). P300 Modulation via Transcranial Alternating Current Stimulation in Adult Attention-Deficit/Hyperactivity Disorder: A Crossover Study. Frontiers in Psychiatry, 13. https://doi.org/10.3389/fpsyt.2022.928145
- Date of first publication of study results:
- 2022-07-18
- DRKS entry published for the first time with results:
- 2023-02-14
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry