An Evaluation of Neurofeedback Efficacy in Adults With ADHD

NCT01852357 | Completed DMC

• 1 other identifier: R15AT007226
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Test of Variables of Attention

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

Other Outcomes (2)

• Adult Self-Report Scale

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

• Mindful Awareness and Attention Scale

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

Study Arms (2)

Sham control

SHAM COMPARATOR

This group will receive 12 sham neurofeedback sessions in which the feedback is based on pre-recorded data.

Other: Sham Neurofeedback

Neurofeedback

EXPERIMENTAL

The intervention will be 24 sessions of beta/SMR neurofeedback.

Other: Neurofeedback

Interventions

Neurofeedback OTHER

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

Also known as: EEG biofeedback

Neurofeedback

Sham Neurofeedback OTHER

Feedback generated by data not associated with the current participant.

Sham control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Wilmington: lead

Study Sites (1)

Department of Psychology, UNC Wilmington

Wilmington, North Carolina, 28403, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Julian R Keith, Ph.D

  University of North Carolina, Wilmington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: May 13, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2014-06

Locations

US (1)