Pilot Explorations of Neurofeedback Issues in Attention Deficit Hyperactivity Disorder (ADHD)
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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.
| Condition | Intervention |
|---|---|
|
Attention Deficit Hyperactivity Disorder |
Device: Neurofeedback |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pilot Explorations of Neurofeedback Issues in ADHD |
- Parent and teacher questionnaire rating of ADHD symptoms. [ Time Frame: At baseline, every 3 treatments for parents, every 6 treatments for teachers, and 2-months post-treatment ] [ Designated as safety issue: No ]
- Functional impairment at home, in school and with peers measured by parent, teacher and clinician rating scales. [ Time Frame: At baseline, treatment 12, treatment 24, treatment 40 and 2-month post-treatment. ] [ Designated as safety issue: No ]
| Enrollment: | 36 |
| Study Start Date: | August 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
|
Device: Neurofeedback
Active neurofeedback vs. sham neurofeedback for 40 treatments, either twice or three times per week.
Other Name: Electroencephalographic biofeedback or EEG biofeedback
|
|
Sham Comparator: 2
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: Neurofeedback
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.
Other Name: Electroencephalographic biofeedback, EEG biofeedback
Device: Neurofeedback
Active neurofeedback vs. sham neurofeedback for 40 treatments, either twice or three times per week.
Other Name: Electroencephalographic biofeedback or EEG biofeedback
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Ohio | |
| The Ohio State University Nisonger Center | |
| Columbus, Ohio, United States, 43210 | |
| Principal Investigator: | L. Eugene Arnold, M.Ed., M.D. | Ohio State University |
More Information
Additional Information:
Publications:
| Responsible Party: | L. Eugene Arnold, Professor Emeritus, Ohio State University |
| ClinicalTrials.gov Identifier: | NCT00886483 History of Changes |
| Other Study ID Numbers: | 2008H0019-A, 1R34MH080775-01A1 |
| Study First Received: | April 22, 2009 |
| Last Updated: | April 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University:
|
Neurofeedback |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013