N/A Completed N=39 Randomized Quadruple-blind Treatment

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

Attention Deficit Hyperactivity Disorder

Source: ClinicalTrials.gov NCT00886483 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2013

Primary outcomePrimary: Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number — 26; 13 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number	26; 13	—
PRIMARY Feasibility of Double-blind, Sham-controlled Design #2. Retention	92.3; 76.9	—
PRIMARY Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind	35; 35; 29; 29; 32; 32	—
PRIMARY Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction	5.21; 5.40; 5.62; 5.08	—
PRIMARY Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice	44; 44; 22; 22	—
PRIMARY Necessary Duration of Treatment	1.91; 1.86; 1.52; 1.51; 1.48; 1.56	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00886483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.