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Pilot Feasibility Study of Neurofeedback for Attention Deficit Hyperactivity Disorder (ADHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00886483
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : November 28, 2013
Last Update Posted : November 11, 2016
National Institute of Mental Health (NIMH)
Brain Resource Center
Information provided by (Responsible Party):
L. Eugene Arnold, Ohio State University

Brief Summary:
Neurofeedback is increasingly advocated for treatment of ADHD despite a thin evidence base. The numerous open and partially controlled studies suffer serious design flaws. In particular, there is no published double-blind randomized clinical trial (RCT), which would control for experimenter and participant biases. The primary aim of this R34 pilot study is to conduct a small-scale pilot with 39 8-12 year-olds with ADHD to prepare for such a larger RCT.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Device: Active Neurofeedback Device: Sham neurofeedback Not Applicable

Detailed Description:
Thirty-nine boys and girls aged 6-12 with rigorously diagnosed DSM-IV ADHD not currently taking medication will be twice-randomized: first to active neurofeedback (n=26) vs. sham neurofeedback (n=13), and simultaneously to 2 vs. 3 times a week treatment frequency (at least 18 in each frequency, 12 active and 6 sham) for 40 treatments. At treatment 24, major assessments will include measures of satisfaction and blinding, and subjects will be given the option of switching to the opposite treatment frequency for the remaining 16 treatments to generate a practical measure of schedule palatability. Major assessments (at baseline, treatment 12, treatment 24, treatment 40, and follow-up) will include measures of symptoms, functional impairment, academic performance/achievement, and neuropsychological tests of attention, vigilance, and executive functioning. Every 3 treatments parents will rate ADHD symptoms and every 6 treatments teachers will rate, to track the response curve over time. Baseline EEG arousal and ADHD subtype will be examined as possible moderators. By determining the optimal frequency and number of treatments and demonstrating feasibility of double blinding, this pilot study should pave the way for a definitive large RCT of neurofeedback.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Explorations of Neurofeedback Issues in ADHD
Study Start Date : August 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Active neurofeedback
In the active neurofeedback condition, the intervention is active neurofeedback (actual neurofeedback) either twice weekly or three times a week (randomized to frequency), with the same amount of total treatment over 40 sessions, varying only in frequency. Neurofeedback will be via the CyberLearning technology, using videogame race car speed and steering as feedback governed by EEG theta-beta ratio through the interface. the game controller is used in the usual fashion, but maximal speed is capped by the threshold theta-beta ratio, which changes from minute-to-minute by fuzzy logic based on the previous minute's ratio. If theta power exceeds a threshold, the rumble function of the controller comes on as a warning. The feedback is transparent to the patient, who just plays the videogame.
Device: Active Neurofeedback
A comparison of active neurofeedback to sham neurofeedback and of two treatment schedules: twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
Other Name: Electroencephalographic biofeedback, EEG biofeedback

Sham Comparator: Sham Neurofeedback
The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
Device: Sham neurofeedback
Active neurofeedback vs. sham neurofeedback for 40 treatments, either twice or three times per week.
Other Name: Electroencephalographic biofeedback or EEG biofeedback

Primary Outcome Measures :
  1. Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number [ Time Frame: 2 years ]
    The feasibility of the double-blind, sham-controlled design was examined in 3 ways, this first way was via the number of participants recruited.

  2. Feasibility of Double-blind, Sham-controlled Design #2. Retention [ Time Frame: 40th treatment sessions ~ 13-20 weeks ]
    The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The second way was via the percentage of participants retained the end of treatment (40th session).

  3. Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind [ Time Frame: Post-treatment at session 40 ]
    The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The 3rd way was the percentage of child and parent post-hoc guess regarding treatment assignment.

  4. Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction [ Time Frame: 24 treatments ~ 8-12 weeks ]
    Parent & child satisfaction of treatment frequency (x2 vs x3 treatments per week) was measured on a likert scale with anchors 0 (indicating low satisfaction) and 7 (indicating high satisfaction).

  5. Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice [ Time Frame: 24 treatments ~ 8-12 weeks ]
    Treatment frequency preference when given choice to change or not to change treatment frequency from 2 to 3X/wk or 3 to 2X/wk at treatment # 24.

  6. Necessary Duration of Treatment [ Time Frame: 40 treatment sessions ~ 13-20 weeks ]
    The necessary duration of treatments was examined via identifying the number of treatments at which improvement stabilized, as shown visually on graphs of parent-rated ADHD symptoms from the SNAP-IV (0-3 scale, lower score is better) for those participants in the Active Neurofeedback who completed 40 treatment sessions.The Sham group is not included in this outcome.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 6-12 inclusive.
  • Boys and girls.
  • Primary diagnosis of ADHD, inattentive or combined type.
  • Not currently taking medication for ADHD.
  • Primary caretaker who can provide frequent parent ratings.
  • Item mean ≥1.5 on a 0-3 metric on parent/teacher ratings of DSM-IV inattentive symptoms or on parent/teacher ratings of all 18 ADHD symptoms (while off medication).
  • IQ 80 or above and mental age of 6 years or more.
  • Willingness and ability to come for 40 treatment sessions and to cooperate with assessments.
  • Informed consent and assent

Exclusion Criteria:

  • Comorbid disorder requiring psychoactive medication including psychosis, bipolar disorder, severe major depression, and severe anxiety disorders. Patients with mild depression or anxiety not requiring pharmacotherapy will be included and the comorbid symptoms will be tracked.Pervasive developmental disorder is exclusionary by DSM-IV definition of ADHD.
  • Medical disorder requiring systemic chronic medication that has confounding psychoactive effects. Asthma inhalants will be allowed, but not chronic systemic corticoids.
  • Mental Retardation.
  • Anything that would interfere with assessments or study treatment or contraindicate study treatment.
  • Plans to move requiring school change during the next 4 months.
  • Antipsychotic agent in the 6 months prior to baseline assessment, fluoxetine or atomoxetine in the 4 weeks prior to baseline, stimulant in the week prior to baseline, or other psychiatric medication in the two weeks prior to baseline.
  • Previous neurofeedback training of more than 5 treatments.

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 identifier (NCT number): NCT00886483

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United States, Ohio
The Ohio State University Nisonger Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
L. Eugene Arnold
National Institute of Mental Health (NIMH)
Brain Resource Center
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Principal Investigator: L. Eugene Arnold, M.Ed., M.D. Ohio State University

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: L. Eugene Arnold, Professor Emeritus, Ohio State University Identifier: NCT00886483     History of Changes
Other Study ID Numbers: 2008H0019-A
1R34MH080775-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 23, 2009    Key Record Dates
Results First Posted: November 28, 2013
Last Update Posted: November 11, 2016
Last Verified: October 2016

Keywords provided by L. Eugene Arnold, Ohio State University:

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms