The therapy is known as HIRREM, which stands for high-resolution, relational, resonance-based, electroencephalic mirroring. For the treatment, patients place sensors — which measure the brain's electrical activity, or brainwaves — on their scalp. The sensors are used to detect whether there are imbalances in the brain's activity between the left and right sides of the brain.
Such imbalances can reflect improper regulation of the autonomic nervous system — the system that's responsible for controlling unconscious bodily functions, such as breathing and heart rate, the researchers said.
A computer then identifies the dominant (or most prominent) brain frequencies, and a software program coverts these brain frequencies into auditory tones, which are played back in real time. Patients listen to these sounds through headphones.
The researchers call these sounds a "reflection" of the brain's activity. They say that the brain can recognize that the tones reflect what is going on in the organ. Once a patient starts hearing the tones, "the electrical pattern tends to shift towards improved balance," study co-author Hossam Shaltout, an assistant professor in the Hypertension and Vascular Research Center at Wake Forest School of Medicine in North Carolina, said in a statement.
In one small study, the researchers tested HIRREM on 10 men and women with high blood pressure. They underwent about 18 HIRREM sessions over 10 days, after which their average systolic blood pressure was reduced from 152 to 136 millimeters of mercury (mm Hg), and their average diastolic pressure was reduced from 97 to 81 mmHg. (Systolic blood pressure is the "top" number in a blood pressure reading and diastolic pressure is the "bottom" number.)
The participants' heart rate variability — which is a measure of the variations in the interval between heartbeats — increased, on average, from 43 to 57 milliseconds. This is a good outcome, because it means that the body has more flexibility to change heart rate in response to blood pressure, Shaltout said.
In another study, 52 adults with migraines underwent about 16 HIRREM sessions over nine days. At the end of the study, participants reported improvements in their headache symptoms.
Because the findings are preliminary and the studies are small, more research is needed to confirm the results, and to determine the ways in which the therapy could be working, the researchers said.
Dr. Kevin Weber, a neurologist and headache specialist at The Ohio State University Wexner Medical Center, who was not involved in the studies, pointed out that neither of these studies included a control group, or a group that received a placebo or "dummy" treatment. The inclusion of a control group is important, because it's possible that the results were due to the placebo effect, Weber said. A placebo effect is one that results from people's belief that the treatment works, rather than from any physiological effect of the treatment.
"I think it is a promising technology," Weber said. However, more research is needed "to make sure that it actually works, as opposed to just being a placebo effect," Weber said.
In 2013, the same group of researchers did conduct a smaller migraine study that included a control group. In that study, which was presented at the 2013 International Headache Congress in Boston, 16 people received the HIRREM treatment and 14 people received a placebo treatment. For the placebo treatment, the participants heard randomly generated musical tones, as opposed to tones that reflected their brainwaves.
The study showed that after the treatments, the likelihood of experiencing a headache was about the same in both groups. But this could have been because the study was too small to detect a meaningful difference between the groups, the researchers said.
Migraines are thought to be caused by abnormalities in the electrical activity of the brain, so it's possible that a treatment like HIRREM, which alters the brain's electrical activity, could affect migraines, Weber said. And the brain and nervous system also play a role in the regulation of blood pressure, so it's possible that HIRREM could have an effect on blood pressure as well, he said.
The researchers also noted that patients in the blood pressure study experienced reduced symptoms of insomnia and anxiety, which might also have an effect on blood pressure.
The studies will be presented this week at the American Heart Association's Council on Hypertension 2016 Scientific Sessions in Orlando. The HIRREM technology is a product of the company Brain State Technologies, which is based in Scottsdale, Arizona. Researchers at Wake Forest School of Medicine have been evaluating HIRREM since 2011, with funding mainly from non-industry sources.
The two new studies were funded by The Susanne Marcus Collins Foundation.
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