In plain terms: EEG Neurofeedback has been tested in human trials aimed at the relevant outcome and did not show benefit at the doses and durations studied. The animal research may be encouraging, but it has not yet translated to humans in these trials.
EEG Neurofeedback
The evidence as the record states it
Neurofeedback Collaborative Group (J Am Acad Child Adolesc Psychiatry, 2021; PMID 32853703): double-blind sham-controlled trial, 144 children aged 7 to 10 with ADHD; no specific effect at the end of treatment or at 13 months. Neurofeedback Collaborative Group (J Am Acad Child Adolesc Psychiatry, 2023; PMID 36521694): the 25-month follow-up of the same trial, again without a specific effect. Westwood et al. (JAMA Psychiatry, 2025; PMID 39661381): meta-analysis of 38 randomized trials, 2,472 participants; with probably blinded ratings the effect on total ADHD symptoms was absent (SMD 0.04, 95% CI -0.10 to 0.18); restricted to standard protocols it was small (SMD 0.21), and the authors conclude neurofeedback does not meaningfully benefit people with ADHD at the group level. van Dongen-Boomsma et al. (J Clin Psychiatry, 2013; PMID 24021501): independent double-blind trial, 41 children aged 8 to 15, 30 sessions of EEG neurofeedback against placebo neurofeedback; no treatment effect on ADHD symptoms or clinical improvement, and children and parents could not guess their assignment better than chance. Cortese et al. (J Am Acad Child Adolesc Psychiatry, 2016; PMID 27238063): meta-analysis; effects disappeared with probably blinded ratings or sham controls. Mei et al. (Front Psychiatry, 2026; PMID 42358407): network meta-analysis of 37 randomized trials, 2,922 participants, of many digital interventions in children and adolescents with ADHD; its neurofeedback ranking rests on unblinded subjective behavioral ratings and cannot carry a grade on its own. The null under blinding is replicated across two sham-controlled trials and two meta-analyses.
Trials showing no benefit
Moderate to high. Largest sham-controlled trial; null at every time point.
Moderate. SMD 0.04 on blinded ratings.
Moderate. Independent trial; null, with blinding confirmed by guess rates at chance.
Why Grade D Route 2 and not Grade C
Grade D Route 2 applies when a compound has been tested in humans and benefit was not shown. EEG Neurofeedback has been tested in 3 human trials on endpoints relevant to the claim being evaluated, and the primary endpoint was not met.
A randomized, placebo-controlled trial pre-specifying a meaningful clinical or functional endpoint and demonstrating statistically significant benefit would move this to Grade C or higher, depending on effect size, population size, and whether it is independently replicated.
What this grade covers and what it does not
What would move this grade
A randomized, placebo-controlled trial pre-specifying a clinical aging endpoint and demonstrating statistically significant benefit on that primary endpoint would be sufficient to move this to Grade C or higher, depending on effect size and population.