Attention Deficit/Hyperactivity Disorder ADHD (inattentive, hyperactive, and impulsive subtypes) F90.0 F98.8
Conditions
Interventions
Group 1: stimulation (anodal tDCS) over bilateral dlPFC
Group 2: Sham-Stimulation
Sponsors
Evangelisches Klinikum Bethel gGmbH
Eligibility
Sex/Gender
All
Age
10 Years to 18 Years
Inclusion criteria
Inclusion criteria: • ADHD according to DSM-5 (all subtypes) • age 10 to 18 • participant and their parents or legal guardian are able and willing to give written informed assent and consent
Exclusion criteria
Exclusion criteria: • IQ < 80 • Birth weight < 2500 gr. • Born before the 37th week of pregnancy • Past or present neurological diseases or brain surgery • Dermatological diseases of the scalp • All psychiatric comorbid disorders other than oppositional defiant disorder, conduct disorder, tic disorder, elimination disorders, anxiety disorders, learning disorders • Cochlear implants • History of craniocerebral injury with loss of consciousness • Heart disease • Pregnancy • Concurrent neurofeedback therapy • Concurrent pharmacological treatment of ADHD and also other medication addressing the central nervous system • Environment not allowing tDCS session without foreseen disturbances essentially impairing the treatment • Expected insufficient compliance towards home-based application* *Self-rated expected compliance and behavioral intention will be measured during telephone screening with short questionnaire
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall accuracy in a Corsi Block Tapping Task (CBTT); Safety and tolerability, as assessed daily during stimulation and at follow-up with open questions and a standardized safety questionnaire, which has been implemented in previous studies (Moliadze et al., 2015; Poreisz et al., 2007); primary endpoints within the 2-3 week stimulation phase; Secondary endpoints approx. 1 week before stimulation phase and up to 9 weeks thereafter | — |
Secondary
| Measure | Time frame |
|---|---|
| • Reaction time and reaction time variability in the CBTT • Experiences, usability, satisfaction with the set-up training as well as acceptance of at-home device and stimulation with the at-home device as well as with the home-based treatment (parent(s), child and clinicians view) • Functional brain related outcome measures (1) resting state EEG: connectivity, phase coherence, Granger causality (2) event related potentials: amplitude, latency, latency / reaction variability, neuronal sources of task relevant components (3) resting state fMRI • Quality of life • Severity of ADHD symptoms (inattention, hyperactivity/ impulsivity) assessed via an ADHD-rating scale adapted to the DSM-V criteria (parent) (Du Paul et al., 2016) • Severity of ADHD symptoms (inattention, hyperactivity/ impulsivity) assessed via the DISYPS-III: SBB-ADHD (child) (Döpfner & Görtz-Dorten, 2017) • Performance measures in neuropsychological tasks that assess impaired functions in ADHD but are different from the task presented during stimulation: accuracy and reaction times / reaction time variability/ error rates in (1) a n-back, (2) an Attention Network task (ANT), and (3) a Sternberg task | — |
Countries
Germany, Portugal
Contacts
Public ContactFabienne Schlechter
Kinder- und Jugendpsychiatrie Evangelisches Klinikum Bethel gGmbH
Outcome results
None listed