Neurofeedback Study ADHD
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Core ADHD symptoms (inattention/hyperactivity/impulsivity) objectively assessed with the computer based Qb-Test (go-no-go-task with infrared camera)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
- •epilepsy,
- •brain disorders and
- •any genetic or medical disorder associated with externalizing behavior that mimics ADHD.
Outcomes
Primary Outcomes
Core ADHD symptoms (inattention/hyperactivity/impulsivity) objectively assessed with the computer based Qb-Test (go-no-go-task with infrared camera)
Time Frame: Pre-Post-Change-Design; change for core symptoms from baseline to after 12 weeks, 6 and 12 months
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
Conners Psychopathology Scores
Time Frame: Pre-Post-Change-Design; change from baseline to psychopathology scores after 12 weeks, 6 and 12 months
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
Secondary Outcomes
- Social Support(Pre-Post-Change-Design; change from baseline to social support scores after 12 weeks, 6 and 12 months)
- Self-Concept(Pre-Post-Change-Design; change from baseline to self-concept scores after 12 weeks, 6 and 12 months)
- Perceived Criticism(Pre-Post-Change-Design; change from baseline to perceived criticism scores after 12 weeks, 6 and 12 months)
- Parental Stress (ESF)(Pre-Post-Change-Design; change from baseline to parental stress scores after 12 weeks, 6 and 12 months)
- Blood/saliva samples for possible genetic correlates of therapy response(End of therapy after 36 sessions)
- Cortisol(Pre-Post-Change-Design; change from baseline to cortisol levels after 12 weeks, 6 and 12 month)
Investigators
Winfried Rief
Prof. Dr.
Philipps University Marburg Medical Center