NCT00886483

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

November 28, 2013

Completed
Last Updated

November 11, 2016

Status Verified

October 1, 2016

Enrollment Period

2.1 years

First QC Date

April 22, 2009

Results QC Date

July 2, 2012

Last Update Submit

October 5, 2016

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Neurofeedback

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Active neurofeedback

ACTIVE COMPARATOR

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.

Device: Active Neurofeedback

Sham Neurofeedback

SHAM COMPARATOR

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: Sham neurofeedback

Interventions

Active NeurofeedbackDEVICE

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.

Also known as: Electroencephalographic biofeedback, EEG biofeedback
Active neurofeedback
Sham neurofeedbackDEVICE

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

Also known as: Electroencephalographic biofeedback or EEG biofeedback
Sham Neurofeedback

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Nisonger Center

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

  • 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.

    PMID: 22090396BACKGROUND

  • 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.

    PMID: 22617866RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Limitations and Caveats

1. Small sample. 2. Self-selection families willing to stop/delay meds. 3. Failure to select for high TBR. 4. Small/medium pre-post ES suggests particular Tx technology may not have been the most effective. 5. Sham NF may not have been inert.

Results Point of Contact

Title
L. Eugene Arnold, M.D. M.Ed.
Organization
The Ohio State University
L.Arnold@osumc.edu
614-685-6708

Study Officials

  • L. Eugene Arnold, M.Ed., M.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Emeritus

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 23, 2009

Study Start

August 1, 2008

Primary Completion

September 1, 2010

Study Completion

June 1, 2011

Last Updated

November 11, 2016

Results First Posted

November 28, 2013

Record last verified: 2016-10

Locations

US(1)