eurofeedback in children with attention deficit hyperactivity disorder (ADHD)
- Conditions
- Attention deficit hyperactivity disorder (ADHD)Mental and Behavioural DisordersHyperkinetic disorders
- Registration Number
- ISRCTN76187185
- Lead Sponsor
- Ruhr-Universität Bochum (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 144
Subjects meeting all of the following criteria will be considered for admission to the trial:
1. Both males and females, aged 7 to less than 10 years inclusive
2. Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of ADHD, combined type
3. Ability of subject to understand character and individual consequences of clinical trial
4. Written informed consent must be available before enrolment in the trial
5. For women with childbearing potential, adequate contraception
1. Below IQ 80 (Culture Fair Test [CFT])
2. Bipolar disorder, psychosis, serious obsessive compulsive disorder (OCD), chronic serious tics or Tourette syndrome
3. Pharmacotherapy for severe anxiety and mood disorders and psychosis
4. Major neurological or medical illness
5. Non-German speaking child and primary caretaker
6. No telephone
7. Suicidal
8. Pregnancy and lactation
9. Participation in other clinical trials and observation period of competing trials, respectively
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in ADHD Rating Scale at pre-test, treatment phase, post-test 1, post-test 2, follow-up.
- Secondary Outcome Measures
Name Time Method The following will be assessed at pre-test, post-test 1, post-test 2, follow-up: <br>1. Clinical Global Impressions - Severity (CGI-S) Scale (at pre-test) and Clinical Global Impressions - Improvement (CGI-I) Scale (at post-test 1, post-test 2, follow-up)<br>2. Resumption of medication by choice of family during follow-up (yes/no) <br>3. Change in neuropsychological and neurophysiological parameters