N/A
Completed N=144
Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD
Source: ClinicalTrials.gov NCT02251743 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Scores of Teacher and Parent Rated Inattentive Symptoms — 2.00; 2.08; 1.51; 1.60 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Scores of Teacher and Parent Rated Inattentive Symptoms |
2.00; 2.08; 1.51; 1.60; 1.43; 1.54 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 5 previous NF treatments
- Vitamin D deficiency will be a temporary exclusion
Data sourced from ClinicalTrials.gov (NCT02251743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.