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

Not Applicable

Completed

Conditions: Attention Deficit Hyperactivity Disorder

Interventions: Device: Sham neurofeedback
Device: Active Neurofeedback

Registration Number: NCT00886483

Lead Sponsor: L. Eugene Arnold

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 39

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Neurofeedback	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.
Active neurofeedback	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number	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.
Necessary Duration of Treatment	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.
Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice	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.
Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind	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.
Feasibility of Double-blind, Sham-controlled Design #2. Retention	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).
Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction	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).