Wearable Brain Stimulator Shows Early Promise In Stroke Recovery

A wearable cap that provides multifocal transcranial magnetic stimulation promotes beneficial brain reorganization and may help improve recovery for stroke survivors, according to a small preliminary study.

In this initial, randomized, double-blind, sham-controlled clinical trial of 30 survivors of ischemic stroke, the treatment produced significant increases in physiological brain activity in areas near the injured brain tissue, as measured by functional MRI.

"The robustness of the increase in physiological brain activity was surprising. With only 30 subjects, a statistically significant change was seen in brain activity," lead investigator Dr. David Chiu, director of the Eddy Scurlock Stroke Center at Houston Methodist Hospital in Texas, said in a news release.

"If confirmed in a larger multicenter trial, the results would have enormous implications. This technology would be the first proven treatment for recovery of motor function after chronic ischemic stroke," said Dr. Chiu.

The results were presented February 20 at the American Stroke Association's International Stroke Conference in Los Angeles.

The 30 study participants had lingering weakness at least 3 months following the stroke. Half received 20 brain stimulation sessions, each lasting 40 minutes, over 4 weeks. The other half received sham stimulation. Researchers analyzed physiologic brain activity before, immediately after and 1 month after treatment.

Active stimulation with the wearable device was well tolerated and produced significantly greater increases in brain activity: nearly nine times higher than the sham stimulation, the researchers report.

Although statistical power was inadequate to establish clinical-endpoint benefits, numerical improvements were observed in five of six clinical scales of motor function and these improvements persisted during a three-month follow-up period.

A multicenter trial is planned, according to the news release.

Commenting on the study in a podcast, Dr. Mitchell Elkind, American Heart Association president-elect and chair of the Advisory Committee of the American Stroke Association, said he views recovery as the "black box of stroke management."

Stroke prevention and acute interventions like endovascular therapy have improved, he explained, "but we're still just beginning to crack open the possibility of what we can do around stroke recovery, and promoting brain reorganization after someone has a stroke," said Dr. Elkind of Columbia University in New York City.

Transcranial magnetic stimulation has been "an exciting potential approach" to doing this and this small study represents a "proof of principle," he added, by demonstrating a change in cortical organization and activation, suggesting that there is "potentially a beneficial effect on the brain, from this approach. This study was too small to prove that there was a clinical benefit, but it really wasn't intended to show that. And there were suggestive benefits even in clinical outcomes also."

"The advantage to this kind of wearable magnetic stimulation is that the patient could have it at home with them. They don't necessarily have to come in to the clinic or to the academic medical center to have this sort of treatment applied to them," said Dr. Elkind.

This study, he said, "really sets the stage for important studies that will be coming down the line in the area of stroke recovery."

The trial was funded by the Houston Methodist Research Institute Translational Research Initiative and Seraya Medical, LLC, the company developing the device.

—Megan Brooks

Source