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Trial record 12 of 155 for:    neurofeedback

An Evaluation of Neurofeedback Efficacy in Adults With ADHD

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ClinicalTrials.gov Identifier: NCT01852357
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Wilmington

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

Condition or disease Intervention/treatment Phase
ADHD Other: Neurofeedback Other: Sham Neurofeedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Control Evaluation of Neurofeedback Efficacy in Adults With ADHD
Study Start Date : April 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

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 Name: EEG biofeedback




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852357


Locations
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United States, North Carolina
Department of Psychology, UNC Wilmington
Wilmington, North Carolina, United States, 28403
Sponsors and Collaborators
University of North Carolina, Wilmington
Investigators
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Principal Investigator: Julian R Keith, Ph.D University of North Carolina, Wilmington

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Responsible Party: University of North Carolina, Wilmington
ClinicalTrials.gov Identifier: NCT01852357     History of Changes
Other Study ID Numbers: R15AT007226 ( U.S. NIH Grant/Contract )
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: June 2014