NIH cuts spotlight a hidden crisis facing patients with experimental
brain implants
[July 28, 2025]
By LAURA UNGAR
Carol Seeger finally escaped her debilitating depression with an
experimental treatment that placed electrodes in her brain and a
pacemaker-like device in her chest. But when its batteries stopped
working, insurance wouldn’t pay to fix the problem and she sank back
into a dangerous darkness.
She worried for her life, asking herself: “Why am I putting myself
through this?”
Seeger’s predicament highlights a growing problem for hundreds of people
with experimental neural implants, including those for depression,
quadriplegia and other conditions. Although these patients take big
risks to advance science, there's no guarantee that their devices will
be maintained — particularly after they finish participating in clinical
trials — and no mechanism requiring companies or insurers to do so.
A research project led by Gabriel Lázaro-Muñoz, a Harvard University
scientist, aimed to change that by creating partnerships between players
in the burgeoning implant field to overcome barriers to device access
and follow-up care.
But the cancellation of hundreds of National Institutes of Health grants
by the Trump administration this year left the project in limbo, dimming
hope for Seeger and others like her who wonder what will happen to their
health and progress.
An ethical quagmire
Unlike medications, implanted devices often require parts, maintenance,
batteries and surgeries when changes are needed. Insurance typically
covers such expenses for federally approved devices considered medically
necessary, but not experimental ones.
A procedure to replace a battery alone can cost more than $15,000
without insurance, Lázaro-Muñoz said.
While companies stand to profit from research, “there’s really nothing
that helps ensure that device manufacturers have to provide any of these
parts or cover any kind of maintenance,” said Lázaro-Muñoz.
Some companies also move on to newer versions of devices or abandon the
research altogether, which can leave patients in an uncertain place.
Medtronic, the company that made the deep brain stimulation, or DBS,
technology Seeger used, said in a statement that every study is
different and that the company puts patient safety first when
considering care after studies end.
People consider various possibilities when they join a clinical trial.
The Food and Drug Administration requires the informed consent process
to include a description of “reasonably foreseeable risks and
discomforts to the participant,” a spokesperson said. However, the FDA
doesn’t require trial plans to include procedures for long-term device
follow-up and maintenance, although the spokesperson stated that the
agency has requested those in the past.
While some informed consent forms say devices will be removed at a
study’s end, Lázaro-Muñoz said removal is ethically problematic when a
device is helping a patient. Plus, he said, some trial participants told
him and his colleagues that they didn’t remember everything discussed
during the consent process, partly because they were so focused on
getting better.
Brandy Ellis, a 49-year-old in Boynton Beach, Florida, said she was
desperate for healing when she joined a trial testing the same treatment
Seeger got, which delivers an electrical current into the brain to treat
severe depression. She was willing to sign whatever forms were necessary
to get help after nothing else had worked.
[to top of second column]
|
Carol Seegar, who has a deep brain stimulator, powered by an Abbott
Brio IPG, implanted in her body, poses for a photo on Thursday, July
24, 2025, in Atlanta. (AP Photo/Mike Stewart)
 “I was facing death,” she said. “So
it was most definitely consent at the barrel of a gun, which is true
for a lot of people who are in a terminal condition.”
Patients risk losing a treatment of last resort
Ellis and Seeger, 64, both turned to DBS as a last resort after
trying many approved medications and treatments.
“I got in the trial fully expecting it not to work because nothing
else had. So I was kind of surprised when it did,” said Ellis, whose
device was implanted in 2011 at Emory University in Atlanta. “I am
celebrating every single milestone because I’m like: This is all
bonus life for me.”
She’s now on her third battery. She needed surgery to replace two
single-use ones, and the one she has now is rechargeable. She’s
lucky her insurance has covered the procedures, she said, but she
worries it may not in the future.
“I can’t count on any coverage because there’s nothing that says
even though I’ve had this and it works, that it has to be covered
under my commercial or any other insurance,” said Ellis, who
advocates for other former trial participants.
Even if companies still make replacement parts for older devices,
she added, “availability and accessibility are entirely different
things,” given most people can’t afford continued care without
insurance coverage.
Seeger, whose device was implanted in 2012 at Emory, said she went
without a working device for around four months when the insurance
coverage her wife’s job at Emory provided wouldn’t pay for battery
replacement surgery. Neither would Medicare, which generally only
covers DBS for FDA-approved uses.
With her research team at Emory advocating for her, Seeger
ultimately got financial help from the hospital's indigent care
program and paid a few thousand dollars out of pocket.
She now has a rechargeable battery, and the device has been working
well. But at any point, she said, that could change.
Federal cuts stall solutions
Lázaro-Muñoz hoped his work would protect people like Seeger and
Ellis.
“We should do whatever we can as a society to be able to help them
maintain their health,” he said.
Lázaro-Muñoz's project received about $987,800 from the National
Institute of Mental Health in the 2023 and 2024 fiscal years and was
already underway when he was notified of the NIH funding cut in May.
He declined to answer questions about it.
Ellis said any delay in addressing the thorny issues around
experimental brain devices hurts patients.
Planning at the beginning of a clinical trial about how to continue
treatment and maintain devices, she said, would be much better than
depending on the kindness of researchers and the whims of insurers.
“If this turns off, I get sick again. Like, I’m not cured,” she
said. “This is a treatment that absolutely works, but only as long
as I’ve got a working device.”
All contents © copyright 2025 Associated Press. All rights reserved |
