Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD

NCT02251743 | Completed Results

• 2 other identifiers: 2013H04171R01MH100144-01A1
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Attention-Deficit/Hyperactivity Disorder

Keywords

ADHD; Attention-Deficit/Hyperactivity Disorder; neurofeedback; EEG

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed at Baseline, Mid-treatment (2 months), End-treatment (4 months), at 6 month follow up, at 13 month follow up

Study Arms (2)

Neurofeedback treatment

EXPERIMENTAL

The intended treatment is downtraining of theta power and uptraining of beta power for 38 treatments of active NF.

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.

Device: Neurofeedback treatment

Interventions

Neurofeedback treatment DEVICE

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: 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)

Neurofeedback treatment; Sham neurofeedback treatment

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ohio State University: lead
• National Institute of Mental Health (NIMH): collaborator
• University of North Carolina: collaborator

Study Sites (2)

University of North Carolina at Asheville

Asheville, North Carolina, 28804, United States

Location

The Ohio State University Nisonger Center

Columbus, Ohio, 43215, United States

Location

Related Publications (5)

• 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.

  PMID: 37971859 DERIVED

• Ging-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.

  PMID: 37157126 DERIVED

• Roley-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.

  PMID: 36526924 DERIVED

• Neurofeedback 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.

  PMID: 36521694 DERIVED

• Neurofeedback 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.

  PMID: 32853703 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

This study tested only one of the standard ADHD protocols, theta-beta NF. Results cannot be generalized to the other standard protocols of slow cortical potential (SCP) and sensory-motor rhythm (SMR) neurofeedback, nor fMRI neurofeedback.

Results Point of Contact

• Title: Dr. L Eugene Arnold
• Organization: Ohio State University

L.Arnold@osumc.edu

614-685-6701

Study Officials

• L. Eugene Arnold, MD, MEd

  The Ohio State University Nisonger Center

  PRINCIPAL INVESTIGATOR

• Roger deBeus, Ph.D.

  University of North Carolina at Asheville

  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: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus of Psychiatry

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 29, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2019
• Study Completion: August 1, 2020
• Last Updated: September 29, 2020
• Results First Posted: September 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)