An Evaluation of Neurofeedback Efficacy in Adults With ADHD

A Placebo-Control 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

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Other: Sham Neurofeedback; Other: Neurofeedback

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Wilmington, North Carolina, United States, 28403
      • Department of Psychology, UNC Wilmington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham control; This group will receive 12 sham neurofeedback sessions in which the feedback is based on pre-recorded data.	Other: Sham Neurofeedback; Feedback generated by data not associated with the current participant.
Experimental: Neurofeedback; The intervention will be 24 sessions of beta/SMR neurofeedback.	Other: Neurofeedback; The intervention will be 24 sessions of beta/sensorimotor rhythm (SMR) neurofeedback.; Other Names: EEG biofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention Performance Index of the Test of Variables of Attention	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).	After 12 neurofeedback or sham sessions (an average of 4 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test of Variables of Attention	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	after 12 (average 4 weeks) and 24 sessions (average 8 weeks) and 1 month followup

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adult Self-Report Scale	A self report survey of ADHD symptoms.	after 12 and 24 sessions (average of 4 and 8 weeks, respectively), 1 month followup
Mindful Awareness and Attention Scale	A self report scale that assesses mindful attention and awareness.	after 12 and 24 sessions (average of 4 and 8 weeks, respectively) and 1 month followup

Collaborators and Investigators

• Sponsor: University of North Carolina, Wilmington
• Investigators: Principal Investigator: Julian R Keith, Ph.D, University of North Carolina, Wilmington

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: April 26, 2013
• First Submitted That Met QC Criteria: May 8, 2013
• First Posted (Estimate): May 13, 2013

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: R15AT007226 (U.S. NIH Grant/Contract)