Oct. 22, 2024 – A headset that can be worn at home to stimulate the brain and treat depression has passed an important research milestone.
The tiny current from the headset may be felt as a faint tingle, and the results of a phase II clinical trial published Monday in the journal Nature Medicine showed that people who used the device for about 2½ months had significant improvement in their depression symptoms.
People in the study who used a device that didn’t provide any current, called a sham device that was used as a control, also saw their depression symptoms get better. But the placebo effect was not as strong as the effect on the people who used the real thing.
Among those who used the real headset, 45% had remission, compared to 22% in the control group, according to a summary of the research published by the University of Texas Health Science Center at Houston, where some of the researchers work.
The headsets use a technology called transcranial direct current stimulation (tDCS) that works by priming nerve cells, called neurons, in the frontal brain regions to more readily send messages throughout the body. This latest study didn’t find any serious safety concerns, although two people did get electrical burns.
“Both were probably caused by insufficient sponge moistening; neither instance of electrical burn developed into residual skin lesions or scarring, and participants were keen to continue the tDCS sessions after a brief break,” the study authors wrote.
The headsets are made by the Swedish company Flow Neuroscience and are already available in Europe over the counter for just under $500, with a monthly rental option around $100. They are not yet fully FDA-approved in the U.S. Even in Europe, the device maker sells the headsets with the recommendation that “if you have depression, you should be under the supervision of a doctor.”
Prior studies of tDCS have been small, and experts have cautioned that the placebo effect has been prominent in many. The draw of at-home treatment without a prescription may be particularly attractive due to the long wait times in the U.S. for psychiatric appointments.
For the study, people used the device at home for 10 weeks; at first, five times per week, and then just three times per week. Sessions lasted 30 minutes.
All of the 174 people were having a depressive episode considered at least moderate in severity according to the Hamilton Depression Rating Scale, which asks about 17 areas ranging from mood to insomnia to digestive symptoms. The average age of the people in the study was 37 years old, and 120 were women and 54 were men. Half were randomly assigned to use the Flow Neuroscience tDCS device, and the other half used a sham device.
Depression is a common mental illness that causes a range of mental, emotional, and physical symptoms almost every day for more than two weeks. The symptoms are so severe that they cause a clear change in a person’s daily functioning, such as impacting their work or school performance, relationships, or hobbies.
Treatment with tDCS is a potential alternative to brain stimulation options that either require in-patient hospitalization or sometimes weeks of daily visits for in-clinic treatments. The latter two stimulation technologies are known as electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS), respectively. ECT is done under general anesthesia and causes a brief seizure, and TMS uses magnetic pulses to induce electric currents in the brain. ECT has been in use for decades, and TMS was first FDA-approved for depression in 2008.
ECT and TMS are often used for treatment-resistant depression, meaning that antidepressant medication or psychotherapy aren’t effective. About one-third of people with major depression have treatment resistant-depression. It’s a particularly challenging condition because ruling out the effectiveness of antidepressants and therapy can take months, and the nature of depression symptoms can impact people’s motivation to try more treatments.
“There is no such thing as the perfect medical intervention. Medication can have unintended side effects, while therapy is both time- and resource-intensive. Our hope is that tDCS can provide a viable third alternative for people with moderate to severe depression to help them better manage their symptoms,” study author Rachel Woodham, MSc, a research assistant at the University of East London, said in a statement.
