Alpha Modulation via transcranial alternating current stimulation in patients with Attention Deficit Hyperactivity Disorder (ADHD) in a realistic environment: a VR-based study
Organizational Data
- DRKS-ID:
- DRKS00022927
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-12-17
- Last update in DRKS:
- 2022-07-14
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
https://www.attention-projekt.de/
Brief summary in lay language
Attention Deficit Hyperactivity Disorder (ADHD) is characterized by inattention, hyperactivity, and impulsivity and leads to massive consequences. The regular treatment includes a combination of psychopharmacotherapy and psychotherapy whereas psychopharmacotherapy is usually more effective. Unfortunately, pharmacotherapeutic interventions need constant observations by medical doctors and are often followed by unwanted side effects. Additionally, research has shown that around 30% of ADHD patients are nonrespondent to pharmacotherapy. Therefore, alternative treatments for ADHD with better respondence and fewer side effects need to be assessed. Studies comparing the brain activity of ADHD patients (children and adults) with healthy controls identified specific differences in their brain activity. One main difference is reduced alpha-activity which can be a possible cause for attentional deficits. Therefore, we would like to investigate if non-invasive electrostimulation leads to increased alpha-activity as well as improved attention in ADHD patients. ADHD patients will execute an attention task (Continuous Performance Test, CPT) in a virtual reality paradigm while their alpha activity either gets stimulated or sham stimulated. Differences in attention with and without the alpha stimulation will be observed.
Brief summary in scientific language
Attention Deficit Hyperactivity Disorder (ADHD) is a frequent psychiatric disorder that is characterized by inattention, hyperactivity and impulsivity. It often leads to massive psychosocial and health economic consequences (Bachmann, Philipsen, & Hoffmann, 2017; Banaschewski et al., 2017). ADHD is usually treated by a combination of psychopharmacotherapy and psychotherapy, whereas psychopharmacotherapy is generally more effective (AWMF S3-Leitlinien, 2018). Unfortunately, pharmacotherapeutic interventions need constant observations by medical doctors and are often followed by unwanted side effects. Additionally, research has shown that around 30% of ADHD Patients are nonrespondent to pharmacotherapy (Cachoeira et al., 2017; Sotnikova et al., 2017). Therefore, alternative treatments with better compliance need to be assessed. Studies comparing the brain activity of ADHD patients (children and adults) with healthy controls identified specific differences in their brain activity. Main differences include a reduced alpha-activity, which can be a possible cause for attentional deficits (Loo et al., 2009; Woltering et al., 2012; Poil et al.,2014; Liu et al, 2016; Deiber et al., 2020). The alpha rhythm is an oscillating activity in the human brain with a frequency range of 8 to 13 Hz (Niedermeyer & Lopes da Silva, 2005) and is associated with basal cognitive functions and attention processes (Klimesch, 2012). Different studies showed, that an increase in alpha power via neurofeedback improves attention as well as clinical symptoms (Bazanova et al., 2018; Deiber et al., 2020). Therefore, we would like to investigate if non-invasive electrostimulation, more specifically through transcranial alternating current stimulation (tACS), leads to increased alpha-activity as well as improved attention in ADHD patients. TACS is a non-invasive method to stimulate brain activity that can modulate endogenous brain oscillations (Herrmann et al., 2013). Several studies showed that the alpha power increased after stimulating with the individual alpha frequency in healthy control groups (f.ex. Kasten, Dowsett & Herrmann, 2016) and had a positive impact on their performance (Kasten & Herrmann, 2017). The study aims to modulate the activity of alpha with a non-invasive tACS-stimulation in adult ADHD patients. A realistic environment is used to test the attention as ecologically valid as possible. Specifically, we would like to investigate to what extent a tACS-based neuromodulation of attention-associated oscillatory networks (especially alpha rhythm) leads to improvements in attention in ADHD patients. Subjects will do a continuous performance task (CPT) while being in a virtual reality paradigm. At the same time, the frequency of alpha will either be stimulated or sham stimulated. The conditions (stimulation vs. sham-stimulation) are blind to the subjects. Afterwards, performances on the CPT-task with and without the alpha stimulation will be compared to assess the effect of increased alpha activity on attention.
Health condition or problem studied
- ICD10:
- F90 - Hyperkinetic disorders
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Alpha modulation via transcranial alternating current stimulation (once for 18 minutes)
- Arm 2:
- Sham-stimulation (once for 20 seconds, while the task itself lasts 18 minutes)
Endpoints
- Primary outcome:
- Performance in the continuous performance test (CPT) during exposure to virtual-reality (i.a. omission and commission errors, reaction time variability); Comparison before and after the respective intervention (Pre-/post comparison).
- Secondary outcome:
- EEG-data, Eyetracking-data
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Other
- Phase:
- No Entry
- 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 Uniklinik Bonn
Recruitment period and number of participants
- Planned study start date:
- 2021-02-01
- Actual study start date:
- 2021-02-25
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2021-07-30
- Target Sample Size:
- 36
- Final Sample Size:
- 24
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 60 Years
- Additional Inclusion Criteria:
- Age between 18-60 years, Normal or corrected eyesight, Fulfillment of DSM-5 criteria for a diagnosis of ADHD
Exclusion Criteria
Serious psychiatric disorders like schizophrenia and/or serious affective disorders, Antisocial personality disorder, Moderate/serious substance use disorder, Serious organic diseases, epilepsy, Seizure disorder in the family, Skin diseases/open wounds on the head, Metal in the brain/skull area, Pregnancy, Bald head or dreadlocks, 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:
- Universitätsklinikum Bonn, Klinik für Psychiatrie und Psychotherapie, VR-LaborDr. rer. nat. Niclas BraunVenusberg-Campus 153127 BonnGermany
- Telephone:
- 0228-28715723
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukbonn.de/virtual-reality
Contact for Public Queries
- Address:
- Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum BonnKyra KannenVenusberg-Campus 153127 BonnGermany
- Telephone:
- 0228-287-15723
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum Bonn, Klinik für Psychiatrie und Psychotherapie, VR-LaborDr. rer. nat. Niclas BraunVenusberg-Campus 153127 BonnGermany
- Telephone:
- 0228-28715723
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukbonn.de/virtual-reality
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:
- 2020-04-24
- Ethics committee number:
- 195/20
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-06-03
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:
- Conclusions based on raw data will be available for every researcher, whithout undue reservations from the authors, within 6 months after publication.
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:
- No Entry
- 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