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 Bonn
Prof. Dr. Alexandra Philipsen
Venusberg-Campus 1
53127 Bonn
Germany
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-Labor
Dr. rer. nat. Niclas Braun
Venusberg-Campus 1
53127 Bonn
Germany
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 Bonn
Kyra Kannen
Venusberg-Campus 1
53127 Bonn
Germany
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-Labor
Dr. rer. nat. Niclas Braun
Venusberg-Campus 1
53127 Bonn
Germany
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 Berlin
Friedrichstraße 130 B
10117 Berlin
Germany
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 Bonn
Venusberg Campus 1, Geb. 02
53105 Bonn
Germany
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
UTN (Universal Trial Number):
No Entry
EUDAMED 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