Trial tests fever-inducing device as potential treatment for ALS

BTT Medical Institute is launching an early-stage clinical trial to test the safety of the Abreu BTT 700 Temperature Management System — a device that slowly raises body temperature to induce a controlled fever — with the goal of developing it as a possible treatment for amyotrophic lateral sclerosis (ALS).

The trial (NCT07564440) aims to enroll approximately 20 healthy volunteers, ages 18 to 65. All participants will undergo one-time treatment with the Abreu BTT 700 System, with the main goal of monitoring safety outcomes. The study is enrolling by invitation at BTT’s site in Florida.

According to a press release from BTT, the launch of this trial “represents the formal clinical translation of a scientific journey spanning more than a decade.” The study will lay the foundation for future clinical trials involving people with ALS and other neurodegenerative disorders, in whom the fever is expected to induce certain cellular responses that will help protect nerve cells.

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An original Abreu BTT 700 system was cleared by U.S. regulators in 2010 for continuous noninvasive temperature-monitoring in clinical settings. The device now being tested in the clinical trial adds a temperature modulating capability that can slowly and precisely raises a person’s body temperature into a controlled fever range.

The launch of the trial comes less than a year after the publication of a case report in which the system was used to treat a 56-year-old woman with ALS. The woman had been diagnosed and was receiving standard treatment, but her disease was nonetheless continuing to worsen over time. Based on the typical trajectory of ALS, she was told she probably had three to five years left to live.

But after undergoing the fever-based treatment, the woman’s ALS completely reversed: she regained motor function, to the point that she was able to resume activities like swimming and pickleball. Clinical tests also no longer showed any signs of the nerve damage that typically characterizes ALS. She stopped other ALS treatments, and more than a year later, she has remained free from any sign of ALS.

This one report does not definitively prove that the Abreu BTT 700 System can safely and effectively reverse ALS. Spontaneous reversal — where ALS suddenly goes away for no clear reason — is exceedingly rare, but it has been documented before. Nonetheless, researchers are optimistic that this case report may represent a first step toward therapy that can meaningfully improve outcomes for ALS patients.

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Device inspired by Nobel Prize winner’s work

The idea of inducing fevers to treat neurological problems is not new — in fact, almost a century ago, in 1927, Austrian physician Julius Wagner-Jauregg was awarded a Nobel Prize in recognition of his discovery that a deliberately induced fever could cure neurological disease.

Wagner-Jauregg’s work specifically focused on treating people with severe complications related to syphilis, a bacterial infection that can cause neurological problems. Wagner-Jauregg found that the disease could be cured by using malaria to induce a high-grade fever — though this approach also killed a substantial portion of patients, and it stopped being used after the advent of antibiotics.

In Wagner-Jauregg’s early experiments, fever was effective for syphilis because it could help the body’s immune system fight off the bacterial infection more effectively.

The Abreu BTT 700 System was inspired by Wagner-Jauregg’s work, but instead of using fever to battle an infection, the goal in ALS and related diseases is to activate the heat-shock response — a quality-control system the body uses to keep proteins functional when cells are under stress, including in high temperatures.

In ALS, toxic clumps of proteins accumulate in nerve cells. By activating the heat-shock response, the system may help refold abnormal proteins, prevent clumping, or clear proteins that can’t be repaired, ultimately reducing the neurological damage that drives disease progression.