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NCT Number: NCT01852357

An Evaluation of Neurofeedback Efficacy in Adults With ADHD

The primary objective of this study is to evaluate the effectiveness of neurofeedback training (NFB) on objective measurements of attention in young adults with ADHD. The secondary objectives are to evaluate neurofeedback effects on self-report measures of attention, ADHD symptoms, and to identify electroencephalogram (EEG) markers of ADHD and neurofeedback efficacy. The study is a double-blind, placebo controlled clinical trial to test the efficacy and safety of EEG neurofeedback in individuals 18-40 years of age with attention deficit hyperactivity disorder (ADHD). Attention will be evaluated at baseline, after 12 and 24 training sessions (an average of 4 and 8 weeks, respectively), and 4 weeks after the last neurofeedback session. The primary outcome will be change from baseline on the Attention Performance Index (API) variable of the Test of Variables of Attention (TOVA) a standardized, well-normed, computerized test of attention, after 12 neurofeedback or sham training sessions (and average of 4 weeks). Secondary outcomes will be change from baseline on other TOVA variables after 12 and 24 sessions (an average of 4 and 8 weeks, respectively), at 4 weeks post-training follow-up, and changes from baseline at each time point on the Adult Self Report Scale (ASRS) and Mindful Awareness and Attention Scale (MAAS). EEG data collected during TOVA attention testing at baseline will be used to model EEG differences between ADHD and non-ADHD participants. Additional EEG data collected during the TOVA at midpoint (average of 4 weeks), after 24 NFB sessions (average of 8 weeks), and 4 weeks post-NFB will be used to develop statistical models to use as indicators of neurofeedback efficacy

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychology, UNC Wilmington

Wilmington, North Carolina, 28403, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be between the ages of 18 and 40 years old.
  • ADHD participants must have a previous diagnosis of ADHD (inattentive or mixed type) by a licensed psychologist or psychiatrist.
  • ADHD participants must have scores on the Adult Self-Report Scale V1.1 (ASRS; (Kessler et al. 2005)) > 24.
  • ADHD participants must have TOVA API z score < 0.
  • Ability to understand study procedures and to comply with them for the entire length of the study.
  • Men and women of reproductive capability will be enrolled. Contraception is not necessary or required.

Exclusion criteria

  • A history of psychiatric disorder.
  • Scores in clinical ranges on the Beck Depression Inventory II (20 or above) or Beck Anxiety Inventory (16 or above).
  • A history of seizures.
  • Known neurological disorders.
  • Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Inability or unwillingness of individual to give written informed consent.

Treatment and study plan

Neurofeedback

Other

The intervention will be 24 sessions of beta/sensorimotor rhythm (SMR) neurofeedback.

Other names: EEG biofeedback

Sham Neurofeedback

Other

Feedback generated by data not associated with the current participant.

Primary outcomes

  1. Attention Performance Index of the Test of Variables of Attention

    Time frame: After 12 neurofeedback or sham sessions (an average of 4 weeks).

    The primary outcome will be change from baseline on the Attention Performance Index (API) variable of the Test of Variables of Attention (TOVA) a standardized, well-normed, computerized test of attention, after 12 neurofeedback or sham training sessions (an average of 4 weeks).

Secondary outcomes

  1. Test of Variables of Attention

    Time frame: after 12 (average 4 weeks) and 24 sessions (average 8 weeks) and 1 month followup

    Secondary outcomes will be change from baseline on other TOVA variables after 12 and 24 sessions (4 and 8 weeks on average, respectively), at 4 weeks post-training follow-up

Other outcomes

  1. Adult Self-Report Scale

    Time frame: after 12 and 24 sessions (average of 4 and 8 weeks, respectively), 1 month followup

    A self report survey of ADHD symptoms.

  2. Mindful Awareness and Attention Scale

    Time frame: after 12 and 24 sessions (average of 4 and 8 weeks, respectively) and 1 month followup

    A self report scale that assesses mindful attention and awareness.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Wilmington

Other

Registry information

Official study title

A Placebo-Control Evaluation of Neurofeedback Efficacy in Adults With ADHD

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 13, 2013
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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