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Clinical Trials/NCT01883765
NCT01883765
Completed
N/A

Efficacy of a Neurofeedback Treatment in Adults With ADHD: a Triple-blind Randomized Placebo-controlled Study

University Hospital Tuebingen1 site in 1 country118 target enrollmentFebruary 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
University Hospital Tuebingen
Enrollment
118
Locations
1
Primary Endpoint
Changes in ADHD symptomatology
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Neurofeedback training (NFT) has been frequently investigated as an alternative treatment for ADHD mainly in children and adolescents. However, randomized double-blind trials that include a sham-neurofeedback control group are lacking, as well as studies examining the efficacy of NFT in adult ADHD populations. The inclusion of a sham-neurofeedback group is crucial to monitor and exclude unspecific effects.

This study aims to investigate the efficacy of NFT as compared to a sham-feedback condition and a cognitive behavioral treatment in adults with persistent ADHD.

Efficacy is assessed on several outcome parameters, such as symptom severity, neuropsychological variables (e.g., attention, memory), and EEG parameters.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
November 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Michael Schoenenberg

Efficacy of a Neurofeedback Treatment in Adults With ADHD: a Triple-blind Randomized Placebo-controlled Study

University Hospital Tuebingen

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Changes in ADHD symptomatology

Time Frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)

Conners' Adult ADHD Rating Scale (CAARS) Scores

Secondary Outcomes

  • Changes in neuropsychological variables: Interference(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
  • Changes in event-related potentials 1(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
  • Changes in event-related potentials 2(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
  • Changes in neuropsychological variables: Attention(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
  • Changes in co-morbid depression scores(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
  • Changes in co-morbid anxiety scores(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
  • Changes in neuropsychological variables: Cognitive Flexibility 1(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
  • Changes in electrophysiological markers(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
  • Changes in neuropsychological variables: Cognitive Flexibility 2(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))

Study Sites (1)

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