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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Explorations of Neurofeedback Issues in ADHD

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Device: Active Neurofeedback
* Device: Sham neurofeedback


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active neurofeedback<br>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<br>* 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.<br>* Other names: Electroencephalographic biofeedback, EEG biofeedback;|
| Sham Comparator: Sham Neurofeedback<br>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<br>* Active neurofeedback vs. sham neurofeedback for 40 treatments, either twice or three times per week.<br>* Other names: Electroencephalographic biofeedback or EEG biofeedback;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number | 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 years | 
| Feasibility of Double-blind, Sham-controlled Design #2. Retention | 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). | 40th treatment sessions   13-20 weeks | 
| Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind | 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. | Post-treatment at session 40 | 
| Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction | 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). | 24 treatments   8-12 weeks | 
| Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice | 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. | 24 treatments   8-12 weeks | 
| Necessary Duration of Treatment | 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. | 40 treatment sessions   13-20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurofeedback