europhysiological Correlates of Deep Pressure Stimulation in Adult Patients with ADHD Compared to Healthy Controls - EEG and PET-fMRI sca

Phase 2

Conditions: F90.0
Disturbance of activity and attention

Registration Number: DRKS00028001

Lead Sponsor: niversität Leipzig Paul-Flechsig Institut für Hirnforschung

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 40

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

- 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)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.<br>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.