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Clinical Trials/NCT01879644
NCT01879644
Unknown
Phase 2

Neurofeedback Study ADHD

Philipps University Marburg Medical Center1 site in 1 country120 target enrollmentJanuary 2011
ConditionsADHD

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
ADHD
Sponsor
Philipps University Marburg Medical Center
Enrollment
120
Locations
1
Primary Endpoint
Core ADHD symptoms (inattention/hyperactivity/impulsivity) objectively assessed with the computer based Qb-Test (go-no-go-task with infrared camera)
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
December 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Winfried Rief

Prof. Dr.

Philipps University Marburg Medical Center

Eligibility Criteria

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)

Study Sites (1)

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