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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Pilot Explorations of Neurofeedback Issues in ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886483
• Other study ID #: 2008H0019-A
• Secondary ID: 1R34MH080775-01A
• Status: Completed
• Phase: N/A
• First received: April 22, 2009
• Last updated: September 26, 2013
• Start date: August 2008
• Est. completion date: June 2011

Study information

• Verified date: September 2013
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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

Locations

Country	Name	City	State
United States	The Ohio State University Nisonger Center	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
L. Eugene Arnold	Brain Resource Center, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epu — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No

External Links

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