Home do-it-yourself (DIY) brain stimulation devices, such as transcranial direct current stimulation (tDCS), are gaining popularity for common mental illnesses such as depression, anxiety, and post-traumatic stress disorder (PTSD). However, questions have arisen about its safety and effectiveness. .
However, the U.S. Food and Drug Administration (FDA) has not yet “fully” approved these devices and has only granted breakthrough device designation to a small number. Additionally, most portable products are not marketed as medical interventions per se, and therefore sit in a regulatory “gray zone” with little oversight.
This has created a freeing environment where individuals can purchase these products online and perform their own “treatments,” often without the guidance or even knowledge of a health care provider.
So how effective and safe are these non-invasive brain stimulators, and what guidance can clinicians give to patients who are using or considering using a brain stimulator at home? Does it need to be provided? What does the research show and what are the ethical considerations?
What the research shows
Data from studies examining unsupervised home use and use under physician supervision are mixed. Results from a recent randomized trial with more than 200 participants found no significant differences in safety or efficacy between adjunctive home-based tDCS and home-based sham tDCS for depressive symptoms.
“To be fair, they didn’t find any unexpected safety issues. What they found was that there was no clear indication that it was working. ,” said Noah S. Phillip, M.D., professor of psychiatry and human behavior at Brown’s Warren Alpert School of Medicine. Providence College in Rhode Island told Medscape Medical News.
Dr. Noah S. Phillip
Philip, who also serves as director of mental health research at the Brown Center for Neural Restoration and Neurotechnology in Providence, Rhode Island, was not involved in this study, but has published other research papers on studies such as depression and adult diseases. He noted that more promising results have been shown for other diseases. Conditions such as attention-deficit/hyperactivity disorder (ADHD) and pain are often not placebo-controlled or include large numbers of patients.
Still, he added, the increased use of these devices reflects the fact that standard treatments often do not meet patients’ needs.
“Broadly speaking, part of the promise with brain stimulation is to try to affect the relevant brain tissue more directly, instead of taking drugs, thus avoiding the problem of systemic side effects from drugs. So there’s certainly a hunger for better interventions,” Philip said.
tDCS involves passing a low-intensity electrical current through electrodes in the scalp to influence brain activity. Generally, less energy is released than other types of non-invasive brain stimulation, such as transcranial magnetic stimulation. “The tradeoff is that it’s a little harder to find a clear signal about how it works,” Philip said.
Therefore, it is important for clinicians to become familiar with these devices, ask about patient use, and set up systematic evaluations of efficacy and adverse events, he added.
Results from a randomized trial published last year in The Lancet found no significant effect of combining in-office use of tDCS and selective serotonin reuptake inhibitors with sham tDCS for major depression.
Meanwhile, a randomized trial published earlier this year in the journal Brain Stimulation showed that older adults who received active tDCS had greater reductions in depressive and anxiety symptoms than the sham group. Ta.
Additionally, results from a small study of eight participants published last year in SAGE Open Medicine showed that adjuvant tDCS helps patients with refractory PTSD. Finally, a randomized trial of 54 veterans from Philip’s own team showed that tDCS and virtual reality were effective for combat-related PTSD.
Although some studies have shown the potential of tDCS for Alzheimer’s disease, Gayatri Devi, MD, of Hofstra/Northwell School of Medicine in Hempstead, New York, and Donald and Barbara Zucker School of Medicine, in Medscape Neurology Decision Point, He states: All of these studies are very small, meaning there are so many different variables in how to interpret the response. ”
On-demand brain stimulation
For home use, this type of device is now widely available online, allowing individuals to provide daily brain stimulation via a headset, eliminating the need to consult a clinician. Most are battery powered and emit low levels of current.
Philip pointed out that there are basically two ways to obtain such a device. Some are easily available in online stores, while others require a prescription. Prescriptions typically include guidelines on how to use the device.
So far, none of these portable products have received full FDA clearance, but the FDA has granted breakthrough device designation to Sooma Medical’s depression treatment device in 2023 and Flow Neuroscience in 2022. Ta.
In August 2023, Flow announced that its device is currently under review for full FDA approval, based on trial results showing home tDCS was “twice as effective” as antidepressants. It was announced that there is. The company received regulatory approval in Europe in 2019.
Other studies have shown “encouraging” results for these home devices for conditions such as ADHD in adults and pain relief with remote monitoring.
Philip noted that more high-quality randomized controlled trials are definitely needed and that “many companies will probably be publishing data soon.”
Is there a possibility that a placebo effect is at work here? “Yes, in part,” said Philip. Users often become more mindful of managing depression and other symptoms, which leads to behavioral changes, he said.
How to easily fix a broken system?
Joseph J. Fins, M.D., and E. William Davis, Jr., M.D., professor of medical ethics and head of the division of medical ethics at Weill Cornell Medical College in New York City, also agree that a placebo effect may be at play. That’s what I think.
“It’s important not to assume the effectiveness of a device without recognizing the placebo effect,” he told Medscape Medical News. That’s why larger, placebo-controlled trials are needed, he added.
There are many reasons why patients choose to use their own home devices. Examples include lack of medicines and lack of timely access to psychiatrists.
“I think this speaks to the sense of isolation that leads them to do this on their own. These devices become a technological band-aid to a fatally broken system. “There’s nothing wrong with that, but at some point they need to be a patient and need a clinician to help them,” he said.
Fins said he is also concerned about regulatory oversight due to how the devices are classified. He likened them to supplements, which, because they don’t make specific claims, are not regulated with the same rigor as other products and fall into the realm of “between the regulatory realms.”
“I think we’re taking an old regulatory framework and trying to better adjust it to accommodate new and evolving technology, and then doing some serious research on how to protect patients who have become consumers. I think we need to make sure that we have enough safety and security that we don’t get so desperate that we don’t get fooled,” Fins said.
When it comes to safety, household devices are unlikely to cause physical harm, at least when used as intended. “The more dangerous situations are when people develop it on their own, use it in excess, or use it in combination with drugs or alcohol or other factors that can produce unpredictable results.” “It happens when you do something,” Philip said.
It added that DIY-assembled products pose a higher risk of burns and excessive energy output. A 2016 “open letter” from a group of neurologists, published in the Annals of Neurology and reported at the time by Medscape Medical News, warned of the dangers of DIY tDCS.
Additionally, Philip said he has witnessed cases of patients becoming manic after using home-based tDCS, especially when attempting to improve cognitive performance.
“In such situations, we have seen a number of unique side effects emerge; typically, in addition to the appearance of mania, anxiety, panic attacks, and sensitivity to bright light; “This will require extensive psychiatric intervention,” he said.
“So it’s important that when people do something like this, there’s some degree of medical involvement,” Philip added.
ethical considerations
Roy Hamilton, M.D., professor of neurology, psychiatry, and physical therapy and rehabilitation at the University of Pennsylvania in Philadelphia, says that in an environment with proper training, proper clinician communication, and proper supervision Home-based tDCS is ethically problematic.
Dr. Roy Hamilton
“For people who have conditions that clearly have a significant negative impact on their quality of life and health, the risk-benefit ratio in terms of potential for harm appears to be quite good,” said Hamilton, who is also the director. from the Penn Center for Neuroscience, Translation, Innovation, and Coordination.
Additionally, tDCS and other transcranial electrical stimulation techniques appear to be safer than “many other things that send patients home to treat pain,” he said.
On the other hand, this risk calculation changes in a scenario where the patient is neurologically intact, he said.
Hamilton pointed out that the brain exhibits functional differences based on the areas that are stimulated. This means that users have to follow certain prescribed methods. However, he noted that those using commercially available devices often lack clear guidance on where to place the electrodes and what strength to use.
“This raises concerns because how the device is used is important,” he said.
Hamilton also highlighted important ethical considerations regarding cognitive enhancement through technology or pharmaceutical intervention. The potential for forced use raises questions about fairness and equity, particularly where individuals feel pressured to use such devices to maintain a competitive edge in academic or professional settings. cause.
This reflects current issues surrounding stimulant use among students, and students without ADHD may be forced to use these drugs to improve their grades. Furthermore, the ability to access cognitively enhancing devices may further exacerbate existing inequalities.
“Whenever we introduce technological interventions, we need to worry about discriminatory justice, where people who can afford such devices or who have access to experts who can provide them “Only those who can receive cognitive improvements,” Hamilton said.
Neither the American Academy of Neurology nor the American Psychiatric Association has established practice guidelines for tDCS for use in clinical settings or at home. Hamilton believes this is due to a current lack of data, noting that organizations would likely want more approval and widespread use before creating guidelines. .
Mr. Finn noted that the use of these devices is becoming a public health issue and emphasized the need for organized medicine to sponsor research. He expressed concern that some devices are marketed as non-medical interventions, even though they involve medical procedures such as brain stimulation. He concluded that scrutiny was necessary but that the current situation should be approached without judgment.
Fins reports no relevant financial relationships. Philip served on Pulvinar Neuro’s Scientific Advisory Board and reported past involvement in clinical trials related to these devices and home use. Mr. Hamilton reported that he serves on the board of the McKnight Brain Research Foundation, which is dedicated to promoting healthy cognitive aging.
