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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active Neurofeedback

Sham neurofeedback

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Neurofeedback

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Ohio State University Nisonger Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active neurofeedback

Sham Neurofeedback

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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).

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.

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).

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00886483

First Posted

April 22, 2009

Last Updated

October 5, 2016

Sponsor

L. Eugene Arnold

Collaborators

National Institute of Mental Health (NIMH), Brain Resource Center

1. Study Identification

Unique Protocol Identification Number

NCT00886483

Brief Title

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

Official Title

Pilot Explorations of Neurofeedback Issues in ADHD

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

L. Eugene Arnold

Collaborators

National Institute of Mental Health (NIMH), Brain Resource Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

Keywords

Neurofeedback

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active neurofeedback

Arm Type

Active Comparator

Arm Description

Arm Title

Sham Neurofeedback

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Active Neurofeedback

Other Intervention Name(s)

Electroencephalographic biofeedback, EEG biofeedback

Intervention Description

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

Intervention Name(s)

Sham neurofeedback

Other Intervention Name(s)

Electroencephalographic biofeedback or EEG biofeedback

Intervention Description

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

Primary Outcome Measure Information:

Title

Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number

Description

The feasibility of the double-blind, sham-controlled design was examined in 3 ways, this first way was via the number of participants recruited.

Time Frame

2 years

Title

Feasibility of Double-blind, Sham-controlled Design #2. Retention

Description

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).

Time Frame

40th treatment sessions ~ 13-20 weeks

Title

Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind

Description

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.

Time Frame

Post-treatment at session 40

Title

Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction

Description

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).

Time Frame

24 treatments ~ 8-12 weeks

Title

Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice

Description

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.

Time Frame

24 treatments ~ 8-12 weeks

Title

Necessary Duration of Treatment

Description

Time Frame

40 treatment sessions ~ 13-20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ohio State University Nisonger Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22090396

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.

Results Reference

background

PubMed Identifier

22617866

Citation

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.

Results Reference

result

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

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