An Evaluation of Neurofeedback Efficacy in Adults With ADHD

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852357
• Other study ID #: R15AT007226
• Status: Completed
• Phase: N/A
• First received: April 26, 2013
• Last updated: October 24, 2016
• Start date: April 2013
• Est. completion date: October 2016

Study information

• Verified date: June 2014
• Source: University of North Carolina, Wilmington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD

Intervention

Other:
• Neurofeedback
The intervention will be 24 sessions of beta/sensorimotor rhythm (SMR) neurofeedback.
• Sham Neurofeedback
Feedback generated by data not associated with the current participant.

Locations

Country	Name	City	State
United States	Department of Psychology, UNC Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Wilmington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Primary	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).	No
Secondary	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	No