A headband that emits electrical current is being tested in a study of people with depression at the Seattle Police Department, in collaboration with researchers at Washington State University.
The study is part of a larger effort to promote wellness among department employees and to assess new ways of improving mental health.
“There is a group of people that select into law enforcement that don’t generally think twice about risking their safety for somebody else, but they often have a difficult time taking care of themselves, or accessing self-care,” Loren Atherly, director of performance analytics and research at SPD, told GeekWire.
SPD has a longstanding program to improve mental health of its employees through peer support and other traditional measures. But it also investigates new ways to provide psychological support.
Though the study is short term and is not designed to assess persistence of any effects, Atherly said that “as an effort to normalize access to self-care, this project is already a success.”
SPD is operating under stress exacerbated by low staffing in the wake of recent budget cuts and employee attrition after the protests sparked by the murder of George Floyd, said WSU researcher Lois James, principal investigator of the study and an associate professor in the college of nursing.
Supporting the mental health of officers benefits the community, said Atherly.
“Healthy employees are best equipped to serve our community. Any opportunity to remind people of the importance of health and wellness reinforces that ethos,” he said.
Old technique, little data
The new study will test a device made by Fisher Wallace Laboratories, a 15 year-old New York City-based company sponsoring the study. The device uses a technology called cranial electrotherapy stimulation (CES) to deliver an electric current to the temples.
It’s an old technique: the first CES device, called the Somniatron, was invented in the Soviet Union in the early part of the 1900s.
Fisher Wallace and other companies sell thousands of such devices each year to treat conditions ranging from anxiety to insomnia and depression.
But despite their longstanding use, little is known about how CES devices work.
Brain imaging studies suggest they could affect neural activity, and some people think they may affect projections of the the vagus nerve, providing calming signals to the heart, gut and other body systems. There is also little known about CES effectiveness, particularly for depression, according to a recent review of the field.
One study of the Fisher Wallace device showed that it reduced depressive symptoms, and another showed no effect on depression compared to a control group. But both studies involved only small numbers of subjects and evaluated them for only a few weeks.
“Clinical trials using this particular device are unimpressive,” Andrew Ko, a neurosurgeon and associate professor in the department of neurological surgery at the University of Washington, said in an email. Many initially promising therapies for depression, especially involving brain stimulation, succeed in pilot studies but fail upon further testing, said Ko.
“Other CES devices exist, and systematic reviews generally conclude there is insufficient evidence to support effectiveness,” added Ko, who is not involved in the SPD study. “This is not to say that this therapy cannot not work, or that it is a bad idea to test these devices on a wider scale. In fact, doing so in a real-world situation is probably a good thing.”
The new study is designed to overcome some of the limitations of previous studies, aiming for large study group with a high mental health burden. Researchers are aiming to enroll 200 police department employees with mild to moderate depression, including first responders.
Police officers have “very high rates of chronic fatigue, excessive daytime sleepiness, and they also have very high rates of anxiety and depression and PTSD. It’s a population that I think is desperately in need of interventions like this,” James said.
James is a research advisor for the International Association of Chiefs of Police, and is also working with SPD on a study assessing the effect of short e-learning modules on sleep and fatigue.
Activate the electrodes
The department has already enrolled more 50 people in the new study since it launched in February. People are treated with the device for eight weeks, and half initially receive a sham device for two weeks, as a control. Participants’ symptoms are evaluated by a physician at telehealth appointments before starting the study and at four weeks, and at other times by self-reporting.
In addition researchers will measure fatigue with a FitBit or other device. The care team is providing access to a device made by a Vancouver, B.C. company, Fatigue Science. The company’s ReadiBand, worn around the wrist, tracks movement and sleep and the accompanying software tracks fatigue and predicts mental performance and reaction times.
Researchers will also track adverse effects. One of the previous studies testing the Fisher-Wallace device for depression showed an association with poor concentration and malaise, but another showed no increase in side effects in the treated population. One survey estimated that side effects like vertigo and headaches occur about 1% of the time.
The technique “is fairly cheap and seems safe,” said Ko. He notes, however, that the SPD study is limited by its short duration, so whether the device can have an effect long term will remain unknown.
Moreover, in other brain stimulation studies for psychiatric diseases, patients can experience a withdrawal effect. That risk is mitigated by the study’s screening of patients for depression and psychiatric conditions, but the protocol could have been strengthened with a specific plan for patients to continue with the device as part of the study if it is helping them, said Ko.
Fisher Wallace aims to submit data from its study to the U.S. Food and Drug Administration this December. The FDA has allowed the sale of Fisher Wallace and other CES devices for years but is now asking companies to submit clinical trial data to support their use. And for depression, the FDA is now requiring a formal approval process.
The company has submitted data to the FDA on a separate study for for anxiety that it said showed an effect, according to a spokesperson.
The headband is currently available on the Fisher Wallace website for $499 and the company makes no other products. It pulled in $4.3 million in revenue last year and has raised in $2.5 million in venture funding and $6.3 million in “equity crowdfunding,” according to a spokesperson. People can invest in the company via a link on its website to the crowdfunding site StartEngine.
The study could also pave the way for future research at SPD.
“This is our first approach in a suite of research projects that we’re calling practical wellness research,” said Atherly, who has used the Fisher Wallace device himself. SPD has no financial interest in the company. “We’re open and receptive to other projects that might help support people’s behavior and well-being.”
Atherly was hired to focus on department analytics and data as part of the 2012 federal “consent decree” designed to reform the department. His four-member team also works with researchers studying criminology, criminal justice and psychology.
“The promise of the consent decree is to build a police department that is able to engage evidence-based decision-making on a pretty agile basis, and where we don’t have evidence for those kind of things, begin to move the science forward and discover more,” said Atherly.
Added Atherly: “Another component of this is also just normalizing accessing self-care technologies.”