fMRI neurofeedback training for improving cognitive control/attention in adults with attention deficit hyperactivity disorder

Completed

Conditions: Attention Deficit Hyperactivity Disorder
Mental and Behavioural Disorders

Registration Number: ISRCTN12390961

Lead Sponsor: BrainGain Consortium

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 20

Inclusion Criteria

1. Diagnosis of ADHD according to the DSM-IV TR criteria (American Psychiatric Association, 2000)
2. Aged 18 years and over
3. Psychopharmaca-naïve or –free, or being on a fixed dose of medication for the study period (patients may pro-actively opt for non-medical treatment)
4. Passing fMRI screening criteria, which consist of the following:
4.1. No previous brain operation
4.2. No epilepsy
4.3. No implants as for example pacemakers or an implanted insulin pump
4.4. No metal parts in the body (protheses, implants, clips on blood vessels, spiral, or other metal objects except teeth fillings and connectors)
4.5. No claustrophobia
4.6. No pregnancy
4.7. IQ > 100 according to block design and vocabulary test WAIS-III-NL (Uterwijk, 2005)

Exclusion Criteria

1. Participation in another clinical trial simultaneously
2. Previous participation in neurofeedback training
3. Other significant medical condition (e.g. neurological, heart or vascular diseases) or regular use of medication other than psychostimulants if the dosis of medication is not fixed for the study period
4. Current diagnosis of one or more Axis I diagnosis other than ADHD according to the DSM-IV TR criteria (American Psychiatric Association, 2000) (e.g. depression, psychosis, tics, autism, eating disorders or behavioural disorders)
5. Current alcohol or drug abuse according to the DSM-IV TR criteria (American Psychiatric Association, 2000)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The severity of ADHD symptoms are measured using the ADHD-DSM-IV rating scale fully based on the DSM-IV before and after training.

Secondary Outcome Measures

Name	Time	Method
1. Sustained attention is measured using both the Sustained Attention dots task (SA-DOTS) as well as the Sustained Attention to Response Task (SART) before and after training<br>2. Working memory is measured using the Digit Span subtest of the WAIS-III-NL to assess verbal working memory and the visuo-spatial Nback task to assess visuo-spatial working memory before and after training<br>3. Cognitive control during interference is measured using the Multi-Source Interference Task before and after training