Attention Deficit Hyperactivity DisorderNCT00886483

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

A study testing Active Neurofeedback in people with Attention Deficit Hyperactivity Disorder, run by L. Eugene Arnold at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 6 to 12 years
Conditions the study is for: Attention Deficit Hyperactivity Disorder
What is being tested?: Active Neurofeedback
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: 1 siteUnited States
Study dates: Aug 2008to Jun 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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).

Show all 9Show fewer

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University Nisonger Center
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Pilot Explorations of Neurofeedback Issues in ADHD

Read the 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
Being tested: Active Neurofeedback, Sham neurofeedback
Keywords: Neurofeedback
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active NeurofeedbackDevice
Also called Electroencephalographic biofeedback, EEG biofeedback
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 neurofeedbackDevice
Also called Electroencephalographic biofeedback or EEG biofeedback
Active neurofeedback vs. sham neurofeedback for 40 treatments, either twice or three times per week.

Study groups in NCT00886483
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Sham neurofeedback

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 40 treatment sessions ~ 13-20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Jun 2011

First posted23 Apr 2009 (estimated)
Study startAug 2008
Primary completionSep 2010
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00886483
Sponsor's protocol ID: 2008H0019-A
Other IDs: 1R34MH080775-01A1
Status last verified: Oct 2016
First submitted: 22 Apr 2009
Last updated: 11 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 22090396
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.
PubMed 22617866

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Explorations of Neurofeedback Issues in ADHD
ClinicalTrials.gov ID: NCT00886483
Acronym / sponsor ID: 2008H0019-A
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Neurofeedback
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: L. Eugene ArnoldUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH), Brain Resource Center
Study start: Aug 2008
Primary completion: Sep 2010 (actual)
Study completion: Jun 2011 (actual)
First posted: 23 Apr 2009 (estimated)
Results: Posted 28 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active neurofeedback	Active comparator	Device: Active NeurofeedbackIn 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.
Sham Neurofeedback	Sham comparator	Device: Sham neurofeedbackThe 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.

Who may qualify

Ages: 6 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active NeurofeedbackAlso: Electroencephalographic biofeedback, EEG biofeedbackA 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.	Device	Active neurofeedback
Sham neurofeedbackAlso: Electroencephalographic biofeedback or EEG biofeedbackActive neurofeedback vs. sham neurofeedback for 40 treatments, either twice or three times per week.	Device	Sham Neurofeedback

Primary outcome

Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number
Time frame: 2 years
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
Time frame: 40th treatment sessions ~ 13-20 weeks
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
Time frame: Post-treatment at session 40
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
Time frame: 24 treatments ~ 8-12 weeks
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
Time frame: 24 treatments ~ 8-12 weeks
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
Time frame: 40 treatment sessions ~ 13-20 weeks
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.

Results and safety

Results posted to the registry on 28 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Neurofeedback	26	24
Sham Neurofeedback	13	10

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

Time frame: 2 years. Number. Unit: participants

Measure	Neurofeedback n = 26	Sham Neurofeedback n = 13
Value	26	13

Population analysed: Based on inclusion \& exclusion criteria and randomization in a 2:1 ratio to active NF vs. sham NF.

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

Time frame: 40th treatment sessions ~ 13-20 weeks. Number. Unit: percentage of participants

Measure	Active Neurofeedback n = 26	Sham Neurofeedback n = 13
Value	92.3	76.9

Population analysed: Number randomized was denominator for percentage of participants completing 40 treatment sessions.

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

Time frame: Post-treatment at session 40. Number. Unit: percentage of participants

Measure	Active Neurofeedback n = 24	Sham Neurofeedback n = 10
Declined to guess by children	35	35
Declined to guess by parent	29	29
Correct guesses by children	32	32
Correct guesses by parents	24	24
Incorrect guesses by children	32	32
Incorrect guesses by parent	47	47

Population analysed: Participants in both Active and Sham Neurofeedback completing 40 treatment sessions.

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

Time frame: 24 treatments ~ 8-12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Active Neurofeedback n = 24	Sham Neurofeedback n = 10
x2 wk Satisfaction	5.21 (1.80)	5.40 (1.07)
x 3/wk Satisfaction	5.62 (1.27)	5.08 (1.73)

Population analysed: Those completing 24 treatments

Adverse events

Time frame: 40 treatment sessions. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Neurofeedback	0 of 26 (0%)	0 of 26 (0%)	Not reported
Sham Neurofeedback	0 of 13 (0%)	0 of 13 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22090396Lofthouse 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 publication: PubMed 22617866Arnold 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.

Related trials for Attention Deficit Hyperactivity Disorder

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

Ohio State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active Neurofeedback in people with Attention Deficit Hyperactivity Disorder, run by L. Eugene Arnold at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00886483, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2016.