Oct. 22, 2024 – A headset that will be worn at home to stimulate the brain and treat depression has reached a significant research milestone.
The headset's tiny current will be felt as a faint tingling sensation, and the outcomes of a Phase II clinical trial were published within the journal on Monday Natural medicine showed that individuals who used the device for about two and a half months showed significant improvement of their depression symptoms.
Participants within the study who used a tool that didn't provide electricity, a so-called sham device that served as a control, also had their depression symptoms improve. However, the placebo effect was not as strong because the effect in individuals who used the unique.
Among those that used the actual headset, 45% experienced remission, in comparison with 22% within the control group, in keeping with one study Summary of research published by the University of Texas Health Science Center at Houston, where a few of the researchers work.
The headsets use a technology called transcranial direct current stimulation (tDCS), which prepares nerve cells called neurons within the frontal regions of the brain to send messages more easily throughout the body. This latest study found no serious safety concerns, although two people suffered electrical burns.
“Both were probably caused by inadequate wetting of the sponge; None of the electrical burn cases progressed to permanent skin lesions or scarring, and participants were eager to continue tDCS sessions after a short break,” the study authors wrote.
The headsets are manufactured by the Swedish company Flow neuroscience and are already available over-the-counter in Europe for slightly below $500, with a monthly rental option of around $100. They aren't yet fully approved by the FDA within the US. Even in Europe, the device manufacturer sells the headsets with the suggestion: “If you suffer from depression, you should be under medical supervision.”
Previous studies on tDCS have been small, and so have the experts warned that the placebo effect was strong for a lot of. Because of the long wait times within the United States for psychiatric appointments, the lure of home treatment with out a prescription will be particularly attractive.
For the study, participants used the device at home for 10 weeks; initially five times per week, then only 3 times per week. The sessions lasted half-hour.
All 174 people had a depressive episode that, in keeping with the study, was classified as not less than moderately severe Hamilton Depression Rating Scalewherein 17 areas are queried, starting from mood to insomnia to digestive symptoms. The average age of the study participants was 37 years, of which 120 were women and 54 were men. Half were randomly assigned to make use of Flow Neuroscience's tDCS device, and the opposite half used a sham device.
depression is a standard mental illness that causes a variety of mental, emotional and physical symptoms almost each day for greater than two weeks. Symptoms are severe enough to cause a big change in an individual's each day functioning, reminiscent of: B. an impairment of their work or school performance, their relationships or hobbies.
tDCS treatment is a possible alternative to brain stimulation options that require either inpatient hospitalization or sometimes weeks of each day visits to the clinic for treatments. The latter two stimulation technologies are known as electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS), respectively. ECT is performed under general anesthesia and causes a transient seizure, and TMS uses magnetic pulses to induce electrical currents within the brain. ECT has been used for many years, and TMS was first approved by the FDA to treat depression in 2008.
ECT and TMS are sometimes used for treatment-resistant depression, meaning antidepressants or psychotherapy aren't effective. About a 3rd of individuals with severe depression have treatment-resistant depression. It is a very difficult condition because it may well take months to find out the effectiveness of antidepressants and therapy, and the character of depression symptoms can affect people's motivation to try further treatments.
“There isn't any perfect medical procedure. Medications can have unintended unintended effects, while therapy is each time and resource intensive. “We hope that tDCS may provide a viable third alternative for people with moderate to severe depression to help them better manage their symptoms,” study creator Rachel Woodham, MSc, a research fellow on the University of East London, said in an announcement Explanation.