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Biofeedback and neurofeedback

Biofeedback reduced migraine and tension headache against waiting lists and headache monitoring, and did not beat drugs or CBT. For ADHD, neurofeedback lowered symptoms only when rated by people who knew the treatment, and not under blinded ratings or against sham. It helped constipation from pelvic floor dyssynergia and added to pelvic floor training for incontinence. No harms were reported.

Checked 2026-11-13
Status
The FDA classifies a biofeedback device, an instrument that gives a visual or sound signal matching a body measure such as brain waves, muscle activity or skin temperature so a person can learn to control it, as a Class II medical device. Prescription battery-powered devices for relaxation training and muscle re-education are exempt from premarket notification [1]. No separate US license for biofeedback practitioners was sourced.
Also called
biofeedback, neurofeedback, EEG biofeedback, EEG neurofeedback, theta/beta training, slow cortical potential training, heart rate variability biofeedback, HRV biofeedback, resonance breathing biofeedback, EMG biofeedback, thermal biofeedback, skin temperature biofeedback, blood volume pulse biofeedback, anorectal biofeedback, pelvic floor biofeedback, brain training
Used for
migraine, tension headache, ADHD, attention and focus, anxiety, stress, chronic back pain, constipation, bladder leakage, urinary incontinence, bowel leakage, fecal incontinence, pelvic floor problems, performance, relaxation

Strong several reviews agree · Moderate one review or consistent trials · Limited one or a few small studies · Untested no study in people, listed with what it rests on

Reported risks0

No risks sourced yet.

What it is used for, and what was found

Shown to help8

Strong

Migraine in adults, compared with a waiting list

Shown to reduce migraine frequency and severity against a waiting list in two meta-analyses, with effects lasting more than a year in follow-up.

Compared with waiting list [2]; control conditions the source abstract does not describe [3]

The numbers and sources
Effect
Across 55 studies, all biofeedback approaches together gave a medium effect (d 0.58, 95% CI 0.52 to 0.64) that held over an average 17 months of follow-up, and outcomes improved more with biofeedback than with control conditions. Attack frequency improved most, and blood-volume-pulse feedback gave larger effects than skin temperature or muscle feedback [3]. A 2025 review of 9 trials (558 participants) found biofeedback reduced headache frequency and severity against a waiting list [2].
Population
55 studies, including randomized trials and before-and-after studies [3]. Adults with migraine in 9 randomized trials [2].
Sources
[3], [2]
Caveats
The 2007 analysis included before-and-after studies with no control group [3]. A waiting list cannot control for attention or expectation.
ModerateStudied in children

Migraine in children, compared with a waiting list

Shown to cut migraine attacks by about 2 a month against a waiting list in children and adolescents, in five small trials.

Compared with waiting list [4]

The numbers and sources
Effect
Biofeedback reduced migraine frequency (mean difference -1.97, 95% CI -2.72 to -1.21), attack duration (-3.94) and headache intensity (-1.77) compared with a waiting list [4].
Population
137 children and adolescents in 5 trials [4].
Sources
[4]
Caveats
Only 40% of risk-of-bias judgments were low, and reporting was often incomplete [4].
Moderate

Tension-type headache

Shown to reduce tension-type headache with a medium to large effect (d 0.73) that lasted about 15 months, more than headache monitoring, placebo or relaxation.

Compared with headache monitoring, placebo, and relaxation therapies [5]

The numbers and sources
Effect
Across 53 studies, biofeedback gave an effect size of 0.73 (95% CI 0.61 to 0.84) that held over an average 15 months of follow-up. Headache frequency improved most, with gains in muscle tension, anxiety, depression and pain medication use. Biofeedback combined with relaxation gave the largest effects, and effects were especially large in children and adolescents [5].
Population
53 studies of tension-type headache [5].
Sources
[5]
Caveats
One meta-analysis from one research group. The abstract does not say how many studies were randomized [5].
Moderate

Anxiety and stress, heart rate variability biofeedback

Shown to reduce self-reported stress and anxiety with a large effect (Hedges' g 0.83) against control conditions, in a meta-analysis of 24 studies.

Compared with control conditions the source abstract does not describe [9]

The numbers and sources
Effect
Heart rate variability biofeedback reduced stress and anxiety within groups (g 0.81) and against control conditions (g 0.83). The effect did not depend on study year, risk of bias, share of women, number of sessions or whether people had an anxiety disorder [9].
Population
484 participants in 24 studies [9].
Sources
[9]
Caveats
Small studies, and outcomes were self-reported. The authors call for more well-controlled trials [9].
Moderate

Chronic back pain

Shown to reduce chronic back pain intensity with a moderate effect (Hedges' g 0.60) that held over about 8 months, alone or added to other treatment.

Compared with control conditions the source abstract does not describe, with before-and-after studies included [10]

The numbers and sources
Effect
Biofeedback reduced pain intensity (g 0.60, 95% CI 0.44 to 0.76), and the effect held at an average 8-month follow-up (g 0.62). It also reduced depression (g 0.40), disability (g 0.49) and muscle tension (g 0.44). Effects held when only controlled studies were analyzed [10].
Population
1,062 patients in 21 studies [10].
Sources
[10]
Caveats
The analysis included uncontrolled studies, and the abstract does not describe the controls [10].
Limited

Constipation from pelvic floor dyssynergia, compared with sham biofeedback

One trial found 4.6 complete bowel movements a week with biofeedback against 2.8 with sham biofeedback at 3 months.

Compared with sham biofeedback [11]

The numbers and sources
Effect
At 3 months, complete spontaneous bowel movements averaged 4.6 a week with manometry biofeedback and 2.8 with sham biofeedback (mean difference 1.80, 95% CI 1.25 to 2.35) [11].
Population
52 adults with chronic constipation and dyssynergic defecation in one trial [11].
Sources
[11]
Caveats
One small trial, and the Cochrane review rated the evidence low or very low [11].
Moderate

Constipation from pelvic floor dyssynergia, compared with laxatives and other treatment

Shown to improve constipation from pelvic floor dyssynergia more often than laxatives, diazepam or other non-biofeedback treatment, in trials rated low in quality.

Compared with laxatives with diet and lifestyle advice, oral diazepam, and standard care [11]; non-biofeedback therapy [12]

The numbers and sources
Effect
Against non-biofeedback therapy, biofeedback raised the odds of clinical improvement (OR 3.63, 95% CI 1.10 to 11.93, 6 trials), and 63% of treated patients improved [12]. In one trial, 80% given biofeedback improved at 6 and 12 months against 22% given laxatives (RR 3.65). In another, 70% improved against 23% on diazepam (RR 3.00). Some surgical procedures did better than biofeedback [11].
Population
725 adults in 11 trials [12]. 931 adults in 17 trials, most with dyssynergic defecation [11].
Sources
[12], [11]
Caveats
Sixteen of 17 trials were at high risk of bias for blinding, and heterogeneity was high [11][12].
ModerateStudied in women

Urinary incontinence in women, added to pelvic floor training

Shown to raise the share of women reporting cure or improvement when biofeedback was added to pelvic floor muscle training, though biofeedback groups often had more contact time.

Compared with pelvic floor muscle training alone [13]

The numbers and sources
Effect
Women given biofeedback with pelvic floor muscle training were more likely to report their incontinence cured or improved than those given training alone; the review reports a risk ratio of 0.75 (95% CI 0.66 to 0.86) [13].
Population
1,583 women with stress, urgency or mixed urinary incontinence in 24 trials [13].
Sources
[13]
Caveats
Women in biofeedback arms often had more contact with a health professional, and many trials were at moderate to high risk of bias [13].

Mixed results2

ModerateStudied in children

ADHD symptoms, rated by those closest to treatment

Mixed results: neurofeedback lowered ADHD ratings slightly (SMD 0.35) when rated by those closest to treatment, the least blinded raters, an effect that disappeared under blinded ratings.

Compared with control conditions in randomized trials, rated by the assessors closest to the treatment setting [6]

The numbers and sources
Effect
With ratings from the assessors most proximal to the treatment setting, the least blinded measure, neurofeedback lowered total ADHD symptoms (SMD 0.35, 95% CI 0.11 to 0.59), inattention (0.36) and hyperactivity-impulsivity (0.26). The same trials showed no significant effect when probably blinded ratings were used [6].
Population
520 children and adolescents in 13 trials [6].
Sources
[6]
Caveats
These were the least blinded measures in the review. Only 4 studies checked whether children learned to change their brain activity [6].
Limited

Fecal incontinence

Limited evidence: single small trials found biofeedback added to exercises or electrical stimulation improved continence, and the Cochrane review could not draw firm conclusions.

Compared with sphincter exercises alone [14]; electrical stimulation alone [14]; sham training [14]; sacral nerve stimulation [14]

The numbers and sources
Effect
Biofeedback plus exercises beat exercises alone (RR for not reaching full continence 0.70, 95% CI 0.52 to 0.94, one trial), and adding biofeedback to electrical stimulation beat stimulation alone (RR 0.47, one trial). Rectal volume discrimination training improved continence more than sham training in some data. Sacral nerve stimulation gave fewer incontinence episodes than conservative care including biofeedback [14].
Population
1,525 adults in 21 trials [14].
Sources
[14]
Caveats
Few trials for each comparison and methodological weaknesses [14].

Not shown to help2

Moderate

Migraine, compared with drugs or other active treatment

Not shown to reduce migraine frequency more than drug treatment or cognitive behavioral therapy in adults, or more than other active treatment in children.

Compared with pharmacotherapy or cognitive behavioral therapy [2]; other active treatment and other behavioral treatment [4]

The numbers and sources
Effect
In 3 trials (278 participants), headache frequency did not differ between biofeedback and active treatments such as drugs or CBT [2]. In children, biofeedback added nothing when combined with other behavioral treatment and had no significant advantage over active treatment [4].
Population
Adults in 3 trials [2]. Children and adolescents in 5 trials [4].
Sources
[2], [4]
Caveats
Few trials, and the 2025 review authors also report a possible added benefit when combined with drugs [2].
Strong

ADHD symptoms, blinded ratings and sham-controlled trials

Not shown to reduce ADHD symptoms when rated by people who did not know the treatment, or against sham neurofeedback, in two meta-analyses and a double-blind trial.

Compared with control conditions rated by assessors probably unaware of the treatment, including active and sham controls [6][7]; sham neurofeedback using prerecorded brain-wave recordings [8]

The numbers and sources
Effect
In 38 trials, ADHD symptom reports by people probably unaware of the treatment showed no improvement (SMD 0.04, 95% CI -0.10 to 0.18, 20 trials, 1,214 participants). Limited to trials using standard protocols, a small improvement appeared (SMD 0.21, 95% CI 0.02 to 0.40). Of five lab measures of thinking, only processing speed improved slightly (SMD 0.35) [7]. An earlier meta-analysis found no significant effect with probably blinded ratings or in trials with active or sham controls, and no effect on lab measures of inhibition or attention [6]. In 144 children given theta/beta neurofeedback or a sham of equal length, parent- and teacher-rated inattention improved in both groups and did not differ at the end of treatment (d 0.01) or 13 months later (d 0.23). Responders were 61% and 54% [8].
Population
2,472 participants aged 5 to 40 in 38 trials [7]. 520 children and adolescents in 13 trials [6]. 142 children aged 7 to 10 with moderate or severe ADHD [8].
Sources
[7], [6], [8]
Caveats
Blinding in the sham trial was rated excellent [8]. The unblinded results are in the block below.

Protocols studied

Headache trials used blood-volume-pulse, skin temperature or muscle (EMG) feedback, often with home practice, which gave larger effects [3]. Tension-type headache trials often combined biofeedback with relaxation [5]. ADHD trials mostly trained brain-wave frequency bands such as theta/beta [6][8], and the sham-controlled trial played back prerecorded brain-wave recordings with each child's own movement artifacts added [8]. Anxiety and stress trials used heart rate variability biofeedback [9]. Constipation trials used anorectal manometry or EMG feedback [11].

Risks

Checked, no increase found1

Limited

Adverse events

Not found: no adverse events were reported for biofeedback in constipation trials, and in a double-blind ADHD trial events occurred as often with sham.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
No adverse events were reported for biofeedback in the Cochrane constipation review, though most trials did not report on harms [11]. In the double-blind ADHD trial, adverse events were distributed proportionally between neurofeedback and sham [8].
Population
931 adults in 17 trials [11]. 142 children [8].
Sources
[11], [8]
Caveats
Harms were not systematically recorded in most trials [11].

Claims tested and not found

  1. That neurofeedback reduces ADHD symptoms beyond sham. Inattention did not differ from a sham of equal length in 142 children, at treatment end or 13 months later [8].
  2. That neurofeedback improves ADHD symptoms under blinded ratings. Probably blinded ratings showed no improvement in 20 trials (SMD 0.04) [7].
  3. That neurofeedback improves inhibition or attention on lab tests. Effects were not significant [6].
  4. That biofeedback prevents migraine better than drugs or CBT. Headache frequency did not differ in 3 trials [2].

Sources

  1. U.S. Food and Drug Administration. 21 CFR 882.5050 Biofeedback device. Code of Federal Regulations. 2026. https://www.ecfr.gov/current/title-21/section-882.5050
  2. Paudel P, Sah A. Efficacy of biofeedback for migraine: a systematic review and meta-analysis. Complementary Therapies in Medicine. 2025. https://doi.org/10.1016/j.ctim.2025.103153
  3. Nestoriuc Y, Martin A. Efficacy of biofeedback for migraine: a meta-analysis. Pain. 2007. https://doi.org/10.1016/j.pain.2006.09.007
  4. Stubberud A, Varkey E, McCrory DC, et al. Biofeedback as Prophylaxis for Pediatric Migraine: A Meta-analysis. Pediatrics. 2016. https://doi.org/10.1542/peds.2016-0675
  5. Nestoriuc Y, Rief W, Martin A. Meta-analysis of biofeedback for tension-type headache: efficacy, specificity, and treatment moderators. Journal of Consulting and Clinical Psychology. 2008. https://doi.org/10.1037/0022-006x.76.3.379
  6. Cortese S, Ferrin M, Brandeis D, et al. Neurofeedback for Attention-Deficit/Hyperactivity Disorder: Meta-Analysis of Clinical and Neuropsychological Outcomes From Randomized Controlled Trials. Journal of the American Academy of Child and Adolescent Psychiatry. 2016. https://doi.org/10.1016/j.jaac.2016.03.007
  7. Westwood SJ, Aggensteiner PM, Kaiser A, et al. Neurofeedback for Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-Analysis. JAMA Psychiatry. 2025. https://doi.org/10.1001/jamapsychiatry.2024.3702
  8. Neurofeedback Collaborative Group (Arnold LE, et al.). Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13-Month Follow-up. Journal of the American Academy of Child and Adolescent Psychiatry. 2021. https://doi.org/10.1016/j.jaac.2020.07.906
  9. Goessl VC, Curtiss JE, Hofmann SG. The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis. Psychological Medicine. 2017. https://doi.org/10.1017/s0033291717001003
  10. Sielski R, Rief W, Glombiewski JA. Efficacy of Biofeedback in Chronic Back Pain: a Meta-Analysis. International Journal of Behavioral Medicine. 2017. https://doi.org/10.1007/s12529-016-9572-9
  11. Woodward S, Norton C, Chiarelli P. Biofeedback for treatment of chronic idiopathic constipation in adults. Cochrane Database of Systematic Reviews. 2014. https://doi.org/10.1002/14651858.CD008486.pub2
  12. Moore D, Young CJ. A systematic review and meta-analysis of biofeedback therapy for dyssynergic defaecation in adults. Techniques in Coloproctology. 2020. https://doi.org/10.1007/s10151-020-02230-9
  13. Herderschee R, Hay-Smith EJ, Herbison GP, et al. Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women. Cochrane Database of Systematic Reviews. 2011. https://doi.org/10.1002/14651858.CD009252
  14. Norton C, Cody JD. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database of Systematic Reviews. 2012. https://doi.org/10.1002/14651858.CD002111.pub3

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