Randomized placebo-controlled trial of high-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), to reduce frequency and severity of migraines
This was a single center, single blind, randomized, placebo-controlled research study for individuals with episodic migraine, who had at least two headache episodes, but no more than 14 headache days per month. The goal was to assess whether the addition of 6 to 16 sessions of HIRREM to usual care would reduce the number and severity of headaches compared to a sham HIRREM placebo plus usual care. The primary outcome was a daily headache diary over the two months following completion of the HIRREM or placebo. A total of 30 participants completed the study protocol.
During the post-intervention period, the HIRREM group had a 33.3% reduction in the likelihood of experiencing headache compared to their baseline, compared to only a 13.5% reduction for those in the placebo group. This promising, clinically relevant effect size for reduced headache frequency was observed for the HIRREM intervention in this pilot trial, beyond that observed for a placebo condition. Exploratory analysis also suggested decreased high frequency temporal asymmetry following HIRREM. The safety, and positive effects to 8 weeks post-intervention suggested that larger controlled trials are warranted.
Results were presented as a poster at the International Headache Conference, Boston, Mass, June 2013.
Open label, randomized, crossover pilot trial of high-resolution,
relational, resonance-based, electroencephalic mirroring (HIRREM) to
This project used a
single center, open label, wait list control, crossover study design,
with a total of 20 participants, 10 per group. Analysis for
differential change of the Insomnia Severity Index (ISI) in the initial
intervention period for HIRREM plus usual care (HUC) compared to
continuation of usual care alone (UC), showed a drop of -10.3 points
(95% CI: -13.7 to -6.9, p < 0.0001, standardized effect size of
2.68). A key secondary outcome included statistically identical
differential change for the crossed-over UC group after they received a
course of HIRREM, and persistence of the effect on the ISI up to 4 weeks
This pilot clinical
trial, the first using HIRREM as an intervention, suggested that HIRREM
is feasible and effective for individuals having moderate to severe
insomnia, with clinically relevant, statistically significant benefits
based on differential change in the ISI. The effects persisted for 4
weeks after completion of HIRREM. This study suggested that larger
controlled research trials were warranted.
were initially presented as a poster at the Sleep 2012 meeting in
Boston, and a manuscript of the results was published in 2012 (see Publications and Presentations).