Carol Seeger, after enduring debilitating depression, found a semblance of relief through experimental treatment involving electrodes implanted in her brain and a pacemaker-like device placed in her chest. However, when the device’s batteries malfunctioned, her insurance refused to cover the necessary repairs, causing her to descend back into a dangerous state of mental health.

Seeger's experience underscores a significant issue faced by individuals with experimental neural implants aimed at treating various conditions, including depression and quadriplegia. These patients take substantial risks to aid scientific progress, yet they often find no assurance that their devices will be maintained after clinical trials conclude. There is currently no obligation for companies or insurers to support ongoing care for these experimental treatments.

A research initiative led by Dr. Gabriel Lázaro-Muñoz at Harvard University sought to create collaborations among stakeholders in the burgeoning field of neural implants to tackle barriers in access and post-trial care. Unfortunately, the abrupt cancellation of hundreds of National Institutes of Health grants by the Trump administration jeopardized this project, leaving hope dim for patients like Seeger, who continuously worry about the future of their health and treatment.

Unlike standard medications, implanted devices require regular maintenance, including parts replacements, battery changes, and possible surgeries. While insurance typically covers expenses for federally approved devices deemed medically necessary, it rarely extends to experimental devices. Dr. Lázaro-Muñoz noted that a single battery replacement procedure can exceed $15,000 without insurance coverage.

Patients often join clinical trials aware of the risks but insufficiently informed about the lack of long-term support regarding device maintenance. Despite the FDA mandating informed consent procedures to outline foreseeable risks, it does not require detailed plans for the ongoing care of experimental devices post-trial. Many participants recall feeling overwhelmed during the consent process, focusing more on the potential benefits rather than the long-term implications.

Brandy Ellis, a 49-year-old resident of Boynton Beach, Florida, revealed her desperation led her to enroll in a trial testing the same DBS treatment that helped Seeger. Faced with numerous failed treatments, Ellis signed the consent forms, viewing them as a necessary sacrifice for potential healing. “I was facing death,” she recalled, emphasizing the life-or-death stakes involved.

Both Ellis and Seeger, after exhausting conventional treatments, sought help through DBS as a last resort. Ellis, who received her device in 2011 at Emory University in Atlanta, expressed surprise at its effectiveness. She has undergone three surgeries to replace batteries thus far—two single-use replacements and currently, one rechargeable battery. Despite her insurance covering these procedures, she remains concerned about future coverage. “I can’t count on any coverage,” she stated, underscoring the lack of guarantees for patients reliant on such devices.

Seeger, who received her device in 2012 at Emory, experienced a four-month period without a functioning device when her insurance wouldn’t pay for battery replacement. Eventually, a combination of advocacy from her research team and financial aid from the hospital’s indigent care program enabled her to afford the necessary procedures.

While Lázaro-Muñoz intended his research project to advocate for the rights and needs of patients like Seeger and Ellis, NIH funding cuts positioned a significant setback to ongoing efforts aimed at addressing the complexities surrounding experimental brain devices. Ellis emphasized the importance of developing protocols at the initiation of clinical trials surrounding treatment continuity and device maintenance rather than depending on the goodwill of researchers or the unpredictability of insurance policies.

“If this turns off, I get sick again. Like, I’m not cured,” expressed Ellis, highlighting the ongoing dependency on the functionality of her device. “This is a treatment that works, but only as long as I have a working device.”