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An Evaluation of Neurofeedback Efficacy in Adults With ADHD

NCT01852357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-10-26

No results posted yet for this study

Summary

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

Conditions

  • ADHD

Interventions

OTHER

Neurofeedback

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

OTHER

Sham Neurofeedback

Feedback generated by data not associated with the current participant.

Sponsors & Collaborators

  • University of North Carolina, Wilmington

    lead OTHER

Principal Investigators

  • Julian R Keith, Ph.D · University of North Carolina, Wilmington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01852357 on ClinicalTrials.gov