Clinical trial NCT00886483: Pilot Feasibility Study of Neurofeedback for Attention Deficit Hyperactivity Disorder (ADHD)
Official title: Pilot Explorations of Neurofeedback Issues in ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Neurofeedback
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Brain Resource Center
First posted: 2009-04-23
Enrollment: 39
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number
timeFrame: 2 years
measure: Feasibility of Double-blind, Sham-controlled Design #2. Retention
timeFrame: 40th treatment sessions ~ 13-20 weeks
measure: Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind
timeFrame: Post-treatment at session 40
measure: Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction
timeFrame: 24 treatments ~ 8-12 weeks
measure: Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice
timeFrame: 24 treatments ~ 8-12 weeks
measure: Necessary Duration of Treatment
timeFrame: 40 treatment sessions ~ 13-20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Nisonger Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: L. Eugene Arnold, M.Ed., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lofthouse N, Arnold LE, Hersch S, Hurt E, DeBeus R. A review of neurofeedback treatment for pediatric ADHD. J Atten Disord. 2012 Jul;16(5):351-72. doi: 10.1177/1087054711427530. Epub 2011 Nov 16.
citation: Arnold LE, Lofthouse N, Hersch S, Pan X, Hurt E, Bates B, Kassouf K, Moone S, Grantier C. EEG neurofeedback for ADHD: double-blind sham-controlled randomized pilot feasibility trial. J Atten Disord. 2013 Jul;17(5):410-9. doi: 10.1177/1087054712446173. Epub 2012 May 22.