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

This study has been completed.
Sponsor:
Collaborators:
Brain Resource Center
Information provided by (Responsible Party):
L. Eugene Arnold, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00886483
First received: April 22, 2009
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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 Intervention
Attention Deficit Hyperactivity Disorder
Device: Active Neurofeedback
Device: Sham neurofeedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Explorations of Neurofeedback Issues in ADHD

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The feasibility of the double-blind, sham-controlled design was examined in 3 ways, this first way was via the number of participants recruited.

  • Feasibility of Double-blind, Sham-controlled Design #2. Retention [ Time Frame: 40th treatment sessions ~ 13-20 weeks ] [ Designated as safety issue: No ]
    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).

  • Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind [ Time Frame: Post-treatment at session 40 ] [ Designated as safety issue: No ]
    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.

  • Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction [ Time Frame: 24 treatments ~ 8-12 weeks ] [ Designated as safety issue: No ]
    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).

  • Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice [ Time Frame: 24 treatments ~ 8-12 weeks ] [ Designated as safety issue: No ]
    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.

  • Necessary Duration of Treatment [ Time Frame: 40 treatment sessions ~ 13-20 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 39
Study Start Date: August 2008
Study Completion Date: June 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886483

Locations
United States, Ohio
The Ohio State University Nisonger Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
L. Eugene Arnold
Brain Resource Center
Investigators
Principal Investigator: L. Eugene Arnold, M.Ed., M.D. Ohio State University
  More Information

Additional Information:
Publications:
Responsible Party: L. Eugene Arnold, Professor Emeritus, The Ohio State University
ClinicalTrials.gov Identifier: NCT00886483     History of Changes
Other Study ID Numbers: 2008H0019-A, 1R34MH080775-01A1
Study First Received: April 22, 2009
Results First Received: July 2, 2012
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Neurofeedback

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014