Attention-Deficit/Hyperactivity DisorderNCT02251743
Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD
A study testing Neurofeedback treatment in people with Attention-Deficit/Hyperactivity Disorder, run by Ohio State University at 2 sites in United States.
Trial summary
Additional treatments with long-term benefit for attention-deficit/hyperactivity disorder (ADHD) are needed; one of the more promising is neurofeedback (EEG biofeedback), which has several randomized controlled trials showing significant benefit, but which are inconclusive because they were not double-blinded; the… Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- Neurofeedback treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Aug 2020
- 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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boys and girls age 7 to 10
- IQ>80
- diagnosed DSM-5 ADHD inattentive presentation or combined presentation
- an item mean ≥1.5 sd above norms on a 0-3 metric both on parent ratings of either DSM-IV inattentive symptoms or all 18 ADHD symptoms and on teacher ratings of either inattentive symptoms or all 18 ADHD symptoms
- an eyes-open QEEG with theta-beta power ratio >4.5 at Cz or Fz
Who cannot join
- comorbid disorder requiring psychoactive medication other than FDA-approved ADHD medication
- a medical disorder requiring systemic chronic medication with confounding psychoactive effects
- sleep apnea
- restless legs syndrome
- IQ <80
- plans to move requiring school change during the next 3 months
Show all 12Show fewer
- plans to start other ADHD treatment in the next 3 months
- antipsychotic agent in the 6 months prior to baseline assessment
- fluoxetine in the 4 weeks prior to baseline
- other psychiatric medication in the two weeks prior to baseline
- ->5 previous NF treatments
- Vitamin D deficiency will be a temporary exclusion
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Asheville
Asheville, North Carolina, 28804
The Ohio State University Nisonger Center
Columbus, Ohio, 43215
About this study
Additional treatments with long-term benefit for attention-deficit/hyperactivity disorder (ADHD) are needed; one of the more promising is neurofeedback (EEG biofeedback), which has several randomized controlled trials showing significant benefit, but which are inconclusive because they were not double-blinded; the benefit could have been nonspecific (placebo response). Because of neurofeedback's labor-intensive cost (1 treatment costing as much as a month's medication), It is important to know how much specific benefit it yields. This 2- site placebo-controlled double-blind randomized clinical trial is the first to test for a specific benefit of neurofeedback with adequate power, the first designed and implemented collaboratively by experts in neurofeedback, ADHD, and clinical trials, the first to rigorously monitor quality not only of treatment, but also of placebo and blinding, and the first to follow up for 2 years to examine enduring effect; the results, whether positive or negative, will provide evidence for clinical practice and public policy regarding ADHD.
Read the detailed description
Current established, evidence-based treatments for attention-deficit/hyperactivity disorder (ADHD) are incompletely effective and not universally acceptable, and appear to wane in effect over time despite significant immediate benefit. E.g., FDA-approved medication, which shows large acute benefit, leaves a third of children only partially treated even when combined with behavioral treatment, and has not been demonstrated effective beyond 2 years. Additional treatments are needed that are effective with persisting benefit, preferably related to a biomarker predicting treatment response. A good candidate is electroencephalographic (EEG) biofeedback, called neurofeedback (NF). It is based on 1) observations that patients with ADHD often have excessive theta band (4-8 Hz) quantitative EEG power, low beta band (13-21 Hz) power, and excessive theta beta ratio (TBR), and 2) theoretical application of operant conditioning to correct this EEG imbalance. Metaanalysis of 6 randomized clinical trials found a large benefit for inattentive symptoms and medium benefit for hyperactive-impulsive symptoms. Unfortunately, none of these were blinded. Three of 4 small blinded studies found no advantage for NF over sham, but used suboptimal NF, leaving the situation inconclusive. Because of the expense and time required by NF, there is a public health need to determine whether it has a specific effect beyond the obvious nonspecific benefit of doing a focused activity several times a week with a friendly,encouraging adult who reinforces for attending to the task. Experts in NF, ADHD, clinical trials, statistics, and data management have joined to design a double-blind sham-controlled randomized clinical trial to answer several pressing scientific and clinical questions in a way that will be credible to all. At each of 2 sites (1 university \& 1 NF clinic) 70 children (total N=140) age 7 through 10 with rigorously diagnosed moderate to severe ADHD and TBR>5 will be randomized in a 3:2 ratio to active TBR downtraining by NF vs. a sham training of equal duration, intensity, and appearance. To keep both participants and study staff blind, the sham will utilize pre-recorded EEGs with the participant's artifacts superimposed. The sham will be programmed into the equipment via internet by an off-site statistician-guided person who has no contact with participants. Treatment fidelity will be trained and monitored by 2 acknowledged NF leaders in a manner that protects blinding. Multi-domain assessments at baseline, mid-treatment, treatment end, and follow-ups at 6 months, 1 year, and 2 years will include parent and teacher ratings of symptoms \& impairment, neuropsychological tests,clinician ratings, and quantitative EEG as well as tests of blinding and of sham inertness. Hypotheses include that NF will improve parent- and teacher-rated inattentive symptoms (primary outcome) and other outcomes more than sham,that benefit will persist for 2 years after training, that initial TBR will moderate treatment response, and that change in TBR will mediate response. Research Domain Criteria and EEG brain changes will be explored, including relationship of TBR to clinical symptoms, executive-function impairment, and sleep.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- Neurofeedback treatment
- Keywords
- ADHD, Attention-Deficit/Hyperactivity Disorder, neurofeedback, EEG
- 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.
Neurofeedback treatmentDevice
Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks:
- The number of half-second periods that they met the reward parameters (i.e. theta mV below threshold; beta mV above threshold)
- Average voltage of theta waves
- Average voltage of beta
- Average ratio of theta to beta power (TBR)
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback treatment | Experimental | The intended treatment is downtraining of theta power and uptraining of beta power for 38 treatments of active NF. Receives: Device: Neurofeedback treatment |
| Sham neurofeedback treatment | Placebo comparator | Participants assigned to sham and their trainers will be fed EEG data from pre-recorded files (recorded during live clinical NF) rather than from the participant's live signal. In order to prevent unblinding of experienced NF trainers/technicians, artifacts from the participant's EMG and EOG are blended into the pre-recorded EEG so that the trainer controlling the feedback cannot differentiate between live and simulated data. To insure trainer/technician blindness, the pre-recorded EEG will be 38 consecutive EEGs from the same age-matched clinical case so that EEGs of the sham group will also show "training progress" over successive sessions, like real NF. Receives: Device: Neurofeedback treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores of Teacher and Parent Rated Inattentive Symptoms
The primary outcome measure is the composite scores of teacher and parent-rated inattentive symptoms on the Conners-3, rated on a scale of 0-3. Lower scores represent a better outcome, with a maximum score of 3 and a minimum score of 0.
Measured: Assessed at Baseline, Mid-treatment (2 months), End-treatment (4 months), at 6 month follow up, at 13 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2019
- Study completionAug 2020
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 (5)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of North Carolina
- Responsible party
- Principal investigator, L. Eugene Arnold, Ohio State University
- Investigators
- L. Eugene Arnold, MD, MEd, Principal investigator, The Ohio State University Nisonger CenterRoger deBeus, Ph.D., Principal investigator, University of North Carolina at Asheville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251743
- Sponsor's protocol ID
- 2013H0417
- Other IDs
- 1R01MH100144-01A1
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2014
- Last updated
- 29 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ging-Jehli NR, Painter QA, Kraemer HA, Roley-Roberts ME, Panchyshyn C, deBeus R, Arnold LE. A diffusion decision model analysis of the cognitive effects of neurofeedback for ADHD. Neuropsychology. 2024 Feb;38(2):146-156. doi: 10.1037/neu0000932. Epub 2023 Nov 16.
PubMed 37971859Ging-Jehli NR, Kraemer HC, Eugene Arnold L, Roley-Roberts ME, deBeus R. Cognitive markers for efficacy of neurofeedback for attention-deficit hyperactivity disorder - personalized medicine using computational psychiatry in a randomized clinical trial. J Clin Exp Neuropsychol. 2023 Mar;45(2):118-131. doi: 10.1080/13803395.2023.2206637. Epub 2023 May 8.
PubMed 37157126Roley-Roberts ME, Pan X, Bergman R, Tan Y, Hendrix K, deBeus R, Kerson C, Arns M, Ging Jehli NR, Connor S, Schrader C, Arnold LE. For Which Children with ADHD is TBR Neurofeedback Effective? Comorbidity as a Moderator. Appl Psychophysiol Biofeedback. 2023 Jun;48(2):179-188. doi: 10.1007/s10484-022-09575-x. Epub 2022 Dec 16.
PubMed 36526924Neurofeedback Collaborative Group. Neurofeedback for Attention-Deficit/Hyperactivity Disorder: 25-Month Follow-up of Double-Blind Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2023 Apr;62(4):435-446. doi: 10.1016/j.jaac.2022.07.862. Epub 2022 Dec 12.
PubMed 36521694Neurofeedback Collaborative Group. Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13-Month Follow-up. J Am Acad Child Adolesc Psychiatry. 2021 Jul;60(7):841-855. doi: 10.1016/j.jaac.2020.07.906. Epub 2020 Aug 25.
PubMed 32853703
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD
- ClinicalTrials.gov ID
- NCT02251743
- Acronym / sponsor ID
- 2013H0417
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Keywords
- ADHD, Attention-Deficit/Hyperactivity Disorder, neurofeedback, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of North Carolina
- Study start
- Sep 2014 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Posted 1 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Additional treatments with long-term benefit for attention-deficit/hyperactivity disorder (ADHD) are needed; one of the more promising is neurofeedback (EEG biofeedback), which has several randomized controlled trials showing significant benefit, but which are inconclusive because they were not double-blinded; the benefit could have been nonspecific (placebo response). Because of neurofeedback's labor-intensive cost (1 treatment costing as much as a month's medication), It is important to know how much specific benefit it yields. This 2- site placebo-controlled double-blind randomized clinical trial is the first to test for a specific benefit of neurofeedback with adequate power, the first designed and implemented collaboratively by experts in neurofeedback, ADHD, and clinical trials, the first to rigorously monitor quality not only of treatment, but also of placebo and blinding, and the first to follow up for 2 years to examine enduring effect; the results, whether positive or negative, will provide evidence for clinical practice and public policy regarding ADHD.
Detailed description
Current established, evidence-based treatments for attention-deficit/hyperactivity disorder (ADHD) are incompletely effective and not universally acceptable, and appear to wane in effect over time despite significant immediate benefit. E.g., FDA-approved medication, which shows large acute benefit, leaves a third of children only partially treated even when combined with behavioral treatment, and has not been demonstrated effective beyond 2 years. Additional treatments are needed that are effective with persisting benefit, preferably related to a biomarker predicting treatment response. A good candidate is electroencephalographic (EEG) biofeedback, called neurofeedback (NF). It is based on 1) observations that patients with ADHD often have excessive theta band (4-8 Hz) quantitative EEG power, low beta band (13-21 Hz) power, and excessive theta beta ratio (TBR), and 2) theoretical application of operant conditioning to correct this EEG imbalance. Metaanalysis of 6 randomized clinical trials found a large benefit for inattentive symptoms and medium benefit for hyperactive-impulsive symptoms. Unfortunately, none of these were blinded. Three of 4 small blinded studies found no advantage for NF over sham, but used suboptimal NF, leaving the situation inconclusive. Because of the expense and time required by NF, there is a public health need to determine whether it has a specific effect beyond the obvious nonspecific benefit of doing a focused activity several times a week with a friendly,encouraging adult who reinforces for attending to the task. Experts in NF, ADHD, clinical trials, statistics, and data management have joined to design a double-blind sham-controlled randomized clinical trial to answer several pressing scientific and clinical questions in a way that will be credible to all. At each of 2 sites (1 university \& 1 NF clinic) 70 children (total N=140) age 7 through 10 with rigorously diagnosed moderate to severe ADHD and TBR>5 will be randomized in a 3:2 ratio to active TBR downtraining by NF vs. a sham training of equal duration, intensity, and appearance. To keep both participants and study staff blind, the sham will utilize pre-recorded EEGs with the participant's artifacts superimposed. The sham will be programmed into the equipment via internet by an off-site statistician-guided person who has no contact with participants. Treatment fidelity will be trained and monitored by 2 acknowledged NF leaders in a manner that protects blinding. Multi-domain assessments at baseline, mid-treatment, treatment end, and follow-ups at 6 months, 1 year, and 2 years will include parent and teacher ratings of symptoms \& impairment, neuropsychological tests,clinician ratings, and quantitative EEG as well as tests of blinding and of sham inertness. Hypotheses include that NF will improve parent- and teacher-rated inattentive symptoms (primary outcome) and other outcomes more than sham,that benefit will persist for 2 years after training, that initial TBR will moderate treatment response, and that change in TBR will mediate response. Research Domain Criteria and EEG brain changes will be explored, including relationship of TBR to clinical symptoms, executive-function impairment, and sleep.
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 |
|---|---|---|
| Neurofeedback treatment | Experimental | Device: Neurofeedback treatmentThe intended treatment is downtraining of theta power and uptraining of beta power for 38 treatments of active NF. |
| Sham neurofeedback treatment | Placebo comparator | Device: Neurofeedback treatmentParticipants assigned to sham and their trainers will be fed EEG data from pre-recorded files (recorded during live clinical NF) rather than from the participant's live signal. In order to prevent unblinding of experienced NF trainers/technicians, artifacts from the participant's EMG and EOG are blended into the pre-recorded EEG so that the trainer controlling the feedback cannot differentiate between live and simulated data. To insure trainer/technician blindness, the pre-recorded EEG will be 38 consecutive EEGs from the same age-matched clinical case so that EEGs of the sham group will also show "training progress" over successive sessions, like real NF. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Boys and girls age 7 to 10
- IQ>80
- diagnosed DSM-5 ADHD inattentive presentation or combined presentation
- an item mean ≥1.5 sd above norms on a 0-3 metric both on parent ratings of either DSM-IV inattentive symptoms or all 18 ADHD symptoms and on teacher ratings of either inattentive symptoms or all 18 ADHD symptoms
- an eyes-open QEEG with theta-beta power ratio >4.5 at Cz or Fz
Key exclusion criteria (12 listed)
- comorbid disorder requiring psychoactive medication other than FDA-approved ADHD medication
- a medical disorder requiring systemic chronic medication with confounding psychoactive effects
- sleep apnea
- restless legs syndrome
- IQ <80
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 |
|---|---|---|
| Neurofeedback treatmentEach session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks: 1. The number of half-second periods that they met the reward parameters (i.e. theta mV below threshold; beta mV above threshold) 2. Average voltage of theta waves 3. Average voltage of beta 4. Average ratio of theta to beta power (TBR) | Device | Neurofeedback treatment, Sham neurofeedback treatment |
Primary outcome
Scores of Teacher and Parent Rated Inattentive Symptoms
Time frame: Assessed at Baseline, Mid-treatment (2 months), End-treatment (4 months), at 6 month follow up, at 13 month follow up
The primary outcome measure is the composite scores of teacher and parent-rated inattentive symptoms on the Conners-3, rated on a scale of 0-3. Lower scores represent a better outcome, with a maximum score of 3 and a minimum score of 0.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37971859Ging-Jehli NR, Painter QA, Kraemer HA, Roley-Roberts ME, Panchyshyn C, deBeus R, Arnold LE. A diffusion decision model analysis of the cognitive effects of neurofeedback for ADHD. Neuropsychology. 2024 Feb;38(2):146-156. doi: 10.1037/neu0000932. Epub 2023 Nov 16.
- Derived from this study: PubMed 37157126Ging-Jehli NR, Kraemer HC, Eugene Arnold L, Roley-Roberts ME, deBeus R. Cognitive markers for efficacy of neurofeedback for attention-deficit hyperactivity disorder - personalized medicine using computational psychiatry in a randomized clinical trial. J Clin Exp Neuropsychol. 2023 Mar;45(2):118-131. doi: 10.1080/13803395.2023.2206637. Epub 2023 May 8.
- Derived from this study: PubMed 36526924Roley-Roberts ME, Pan X, Bergman R, Tan Y, Hendrix K, deBeus R, Kerson C, Arns M, Ging Jehli NR, Connor S, Schrader C, Arnold LE. For Which Children with ADHD is TBR Neurofeedback Effective? Comorbidity as a Moderator. Appl Psychophysiol Biofeedback. 2023 Jun;48(2):179-188. doi: 10.1007/s10484-022-09575-x. Epub 2022 Dec 16.
- Derived from this study: PubMed 36521694Neurofeedback Collaborative Group. Neurofeedback for Attention-Deficit/Hyperactivity Disorder: 25-Month Follow-up of Double-Blind Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2023 Apr;62(4):435-446. doi: 10.1016/j.jaac.2022.07.862. Epub 2022 Dec 12.
- Derived from this study: PubMed 32853703Neurofeedback Collaborative Group. Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13-Month Follow-up. J Am Acad Child Adolesc Psychiatry. 2021 Jul;60(7):841-855. doi: 10.1016/j.jaac.2020.07.906. Epub 2020 Aug 25.
- Individual participant dataSharing planned: No
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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, MD, MEd principal investigator
The Ohio State University Nisonger Center
Roger deBeus, Ph.D. principal investigator
University of North Carolina at Asheville
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback treatment in people with Attention-Deficit/Hyperactivity Disorder, run by Ohio State University at 2 sites 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 5 inclusion and 12 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 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 Sep 2020). 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?
Scores of Teacher and Parent Rated Inattentive Symptoms (time frame: Assessed at Baseline, Mid-treatment (2 months), End-treatment (4 months), at 6 month follow up, at 13 month follow up). 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 NCT02251743, which also lists 5 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 29 Sep 2020.