Neurofeedback Study ADHD

ADHD Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01879644
• Other study ID #: NF-HC
• Status: Recruiting
• Phase: Phase 2
• First received: May 28, 2013
• Last updated: November 14, 2016
• Start date: January 2011
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: Philipps University Marburg Medical Center
• Contact: Hanna Christiansen, PhD
• Phone: 0049 6421 28
• Email: christih[@]staff.uni-marburg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Neurofeedback has proved to be effective in treating Attention deficit hyperactivity disorder (ADHD) in experimental settings. This study investigates whether neurofeedback can be used as a therapeutic intervention in regular outpatient care. The investigators compare high frequent neurofeedback with high frequent self-management therapy and suppose that both result in comparable effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

Inclusion Criteria:

• children with ADHD aged 7 to 11

• full command of the German language.

Exclusion Criteria:

• IQ below 80

Children with symptoms of:

• inattention,

• hyperactivity or

• impulsivity due to other medical reasons such as:

• hyperthyreosis,

• autism,

• epilepsy,

• brain disorders and

• any genetic or medical disorder associated with externalizing behavior that mimics ADHD.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• NF

• SM

• PE

• SU

Locations

Country	Name	City	State
Germany	Philipps-University Marburg, Department of Psychology, Clinical Child and Adolescent Psychology	Marburg	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Christiansen H, Reh V, Schmidt MH, Rief W. Slow cortical potential neurofeedback and self-management training in outpatient care for children with ADHD: study protocol and first preliminary results of a randomized controlled trial. Front Hum Neurosci. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core ADHD symptoms (inattention/hyperactivity/impulsivity) objectively assessed with the computer based Qb-Test (go-no-go-task with infrared camera)	Children perform the Qb-Test: T1 baseline diagnostic before therapy, 1 week; T2 post assessment after 36 therapy sessions, expected average of 12 weeks; T3 catamnestic measurement 6 months after T2; T4 catamnestic measurement 12 months after T2	Pre-Post-Change-Design; change for core symptoms from baseline to after 12 weeks, 6 and 12 months	No
Primary	Conners Psychopathology Scores	Conners parents & teacher rating scales: T1 baseline diagnostic before therapy, 1 week; T2 post assessment after 36 therapy sessions, expected average of 12 weeks; T3 catamnestic measurement 6 months after T2; T4 catamnestic measurement 12 months after T2	Pre-Post-Change-Design; change from baseline to psychopathology scores after 12 weeks, 6 and 12 months	No
Secondary	Social Support	Children's social support scale: T1 baseline diagnostic before therapy, 1 week; T2 post assessment after 36 therapy sessions, expected average of 12 weeks; T3 catamnestic measurement 6 months after T2; T4 catamnestic measurement 12 months after T2	Pre-Post-Change-Design; change from baseline to social support scores after 12 weeks, 6 and 12 months	No
Secondary	Self-Concept	Children's self-concept interview: T1 baseline diagnostic before therapy, 1 week; T2 post assessment after 36 therapy sessions, expected average of 12 weeks; T3 catamnestic measurement 6 months after T2; T4 catamnestic measurement 12 months after T2	Pre-Post-Change-Design; change from baseline to self-concept scores after 12 weeks, 6 and 12 months	No
Secondary	Perceived Criticism	Assessment of children's perceived criticism: T1 baseline diagnostic before therapy, 1 week; T2 post assessment after 36 therapy sessions, expected average of 12 weeks; T3 catamnestic measurement 6 months after T2; T4 catamnestic measurement 12 months after T2	Pre-Post-Change-Design; change from baseline to perceived criticism scores after 12 weeks, 6 and 12 months	No
Secondary	Parental Stress (ESF)	Parent Stress Questionnaire: T1 baseline diagnostic before therapy, 1 week; T2 post assessment after 36 therapy sessions, expected average of 12 weeks; T3 catamnestic measurement 6 months after T2; T4 catamnestic measurement 12 months after T2	Pre-Post-Change-Design; change from baseline to parental stress scores after 12 weeks, 6 and 12 months	No
Secondary	Cortisol	Assessed with hair-samples: T1 baseline diagnostic before therapy, 1 week; T2 post assessment after 36 therapy sessions, expected average of 12 weeks; T3 catamnestic measurement 6 months after T2; T4 catamnestic measurement 12 months after T2	Pre-Post-Change-Design; change from baseline to cortisol levels after 12 weeks, 6 and 12 month	No
Secondary	Blood/saliva samples for possible genetic correlates of therapy response	Either saliva sampling or blood samples for genotyping of ADHD candidate genes to establish possible correlates of therapy response	End of therapy after 36 sessions	No

External Links

•   Comparison of Neurofeedback and Self-Management Training in an outpatient clinic.