Completed Projects

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 relieve insomnia 

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 post-HIRREM.

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.

Results 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).


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