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

NCT ID: NCT00886483

Last Updated: 2016-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-06-30

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Neurofeedback

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Active Neurofeedback

Intervention Type: DEVICE

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.

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.

Group Type: SHAM_COMPARATOR

Sham neurofeedback

Intervention Type: DEVICE

Active neurofeedback vs. sham neurofeedback for 40 treatments, either twice or three times per week.

Interventions

Active 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.

Intervention Type: DEVICE

Sham neurofeedback

Active neurofeedback vs. sham neurofeedback for 40 treatments, either twice or three times per week.

Intervention Type: DEVICE

Other Intervention Names

Electroencephalographic biofeedback, EEG biofeedback; Electroencephalographic biofeedback or EEG biofeedback

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Brain Resource Center

OTHER

Sponsor Role: collaborator

L. Eugene Arnold

OTHER

Sponsor Role: lead

Responsible Party

L. Eugene Arnold

Professor Emeritus

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

L. Eugene Arnold, M.Ed., M.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Nisonger Center

Columbus, Ohio, United States

Countries

United States

References

Lofthouse N, Arnold LE, Hersch S, Hurt E, DeBeus R. A review of neurofeedback treatment for pediatric ADHD. J Atten Disord. 2012 Jul;16(5):351-72. doi: 10.1177/1087054711427530. Epub 2011 Nov 16.

Reference Type: BACKGROUND

PMID: 22090396 (View on PubMed)

Arnold LE, Lofthouse N, Hersch S, Pan X, Hurt E, Bates B, Kassouf K, Moone S, Grantier C. EEG neurofeedback for ADHD: double-blind sham-controlled randomized pilot feasibility trial. J Atten Disord. 2013 Jul;17(5):410-9. doi: 10.1177/1087054712446173. Epub 2012 May 22.

Reference Type: RESULT

PMID: 22617866 (View on PubMed)

Other Identifiers

1R34MH080775-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2008H0019-A

Identifier Type: -

Identifier Source: org_study_id