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Pilot Explorations of Neurofeedback Issues in Attention Deficit Hyperactivity Disorder (ADHD) - NCT00886483-43210(Clinical Trial 288377)



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City:  Columbus
State:  
OH
Zip Code: 43210
Conditions: Attention Deficit Hyperactivity Disorder
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 36 8-12 year-olds with ADHD to prepare for such a larger RCT.
Study summary: Thirty-six 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=24) vs. sham neurofeedback (n=12), and simultaneously to 2 vs. 3 times a week treatment frequency (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.
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.
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Data Source: ClinicalTrials.gov
Date Processed: June 22, 2010
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