F90.0
Conditions
Interventions
Group 1: Weighted blankets/ patients with ADHD and healthy controls
15 minutes during EEG measurement
90 minutes during PET-MRI.
Group 2: Comparison condition without weight in ADHD and healthy subjects
Sponsors
Universität Leipzig Paul-Flechsig Institut für Hirnforschung
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: - Age of study participants = 18 years and < 60 years - ADHD in adulthood according to DSM-V criteria - Ability to understand study information and provide written informed consent - Ability to follow study procedures and lie flat in PET-MRI scanner - Written consent to study participation - Consent in accordance with Section 7, Paragraph 2, No. 15 of the GCP Ordinance on the transfer of pseudonymised data as part of the documentation and notification obligations under Sections 12 and 13 of the GCP Ordinance. - Drug-naive or if you have previously taken methylphenidate or atomoxetine with a 4-week washout period for the respective drug (methylphenidate or atomoxetine)
Exclusion criteria
Exclusion criteria: - Age: < 18 years and = 60 years - BMI < 19 or = 30 kg/m2 - Acute suicidality - Addiction to illegal drugs in the last 6 months (DUDIT, Berman 2005) - Dependence on alcohol in the last 6 months (AUDIT, Selin 2006) - Psychotic symptoms - Co-morbid organic mental disorder (ICD-10:F0) or schizophrenic disorder (ICD-10:F2) (SKID) (First, 1995) - Presence of a major depressive episode or a manic episode - Pregnancy - Nursing mother - Neurosurgical interventions in the past - structural tissue lesions (e.g. cerebral infarction, head trauma, etc.) - long-term use of psychotropics - Taking prednisolone or methylprednisolone - Simultaneous participation in an interventional clinical trial according to AMG (drug testing)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary goal of the DPS study is to record neurophysiological and biological parameters in comparison with and without sand cover in adult patients with ADHD and healthy controls before and after DPS based on EEG and PET-MRI data. In addition to EEG parameters of arousal regulation, the primary endpoint is the quantification of central NAT availability with the calculated parameters of the DV. | — |
Secondary
| Measure | Time frame |
|---|---|
| The measured PET parameters are also analyzed in combination with structural and functional MRI parameters (examinations in the resting state as well as under DPS) in order to record the modulation of neural networks. Further correlative analyzes involve behavioral variables (e.g. Conner's ADHD alertness scales, WURS-k), stress parameters (salivary cortisol, heart rate, arousal questionnaire) and other visual analogue scales for ratings of well-being with/without sand cover. | — |
Countries
Germany
Contacts
Public ContactStephanie Müller
Universität Leipzig Paul-Flechsig Institut für Hirnforschung
Outcome results
None listed