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Completed

NCT Number: NCT00886483

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Nisonger Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Neurofeedback

Device

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 names: Electroencephalographic biofeedback, EEG biofeedback

Sham neurofeedback

Device

Active neurofeedback vs. sham neurofeedback for 40 treatments, either twice or three times per week.

Other names: Electroencephalographic biofeedback or EEG biofeedback

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

L. Eugene Arnold

Other

Collaborators

  • Brain Resource Center
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Pilot Explorations of Neurofeedback Issues in ADHD

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Apr 23, 2009
Registry last updated
Nov 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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