Early neurotechnology trials have seen some success. Here are the details

Neuromodulation technology, also known as neurotechnology, is making a return as a form of treatment for a range of medical conditions. Most recently, it’s appeared in clinical trials for Alzheimer’s, depression, and chronic pain therapies.

Here’s a roundup of three ongoing neurotech studies that we’re keeping an eye on.

Alzheimer’s

Massachusetts-based biotech company Sinaptica Therapeutics is using repetitive transcranial magnetic stimulation treatment, which activates nerve cells in the brain with magnetic fields, to help improve symptoms of Alzheimer’s-related dementia as well as cognitive and functional decline.

The treatment is personalized to match each patient’s brain activity patterns. Sinaptica’s most recent data—from a small, 52-week Phase 2 trial of 32 Alzheimer’s patients with mild to moderate symptoms—expands on the company’s findings that the tech improved symptoms of Alzheimer’s at 24 weeks. The findings were published in a 2022 study in journal Brain.

Compared to control patients who received a placebo, or “fake stimulation,” the 32 participants who successfully received the weekly treatments in the study ranked 1.09 points higher on the Clinical Dementia Rating Scale, a five-point rating system that evaluates cognitive and functional performance in patients impacted by Alzheimer’s and related dementia. According to researchers, the 1.09-point difference is “statistically significant” and correlates to a noticeable change in the progression of disease.

Sinaptica is planning to recruit around 300 patients for its upcoming Phase 3 trial slated for next year, according to Mariash.

Depression

Sweden-based Flow Neuroscience is using at-home transcranial direct current stimulation (tDCS), which delivers a low-level electrical current to the brain, as a treatment for depression symptoms in adults.

Results from a 174-person Phase 2 trial in October showed that patients who received the treatment, as opposed to a placebo, reported on average a 2.27 point larger decrease in depression symptoms as ranked by the Hamilton Depression Rating Scale, a 17-question assessment clinicians widely used to evaluate the symptoms and severity of depression in a patient. Scores range from zero to 52, and those over 24 are generally categorized as severe depression.

“The idea of doing it at home is interesting,” Ankur Butala, a neurologist at Johns Hopkins Medicine (who was not involved in the study), told Healthcare Brew, noting that this could extend the accessibility of trials since it wouldn’t require patients to go to a care facility.

“The way [tDCS has] been used most of the time that I’m familiar with is to enhance rehabilitation,” he added.

However, the downside of tDCS, Butala noted, is that the effect is often minimal, and it tends to fizzle out once patients stop treatment. Plus, not everyone responds to tDCS in the same way because each patient’s brain and what’s being treated are different.

Pain

Researchers from the University of Arizona are currently working with devices company ni2o on a clinical trial to evaluate the use of tDCS for pain treatment. The trial uses the Rhode Island-based company’s tKIWI device, which analyzes brain activity signals and provides “customized currents for treatment,” according to the company’s website.

“A lot of the tDCS is still clinical trial-type work. We’re still trying to get data,” Todd Vanderah, professor of pharmacology and director of the University of Arizona Health Sciences Comprehensive Center for Pain and Addiction—as well as an author on one clinical trial evaluating ni2o’s device for chronic pain and substance use disorder management—told Healthcare Brew.

Researchers have more evidence showing that the amygdala is behind the emotional component of pain, and that the anterior cingulate cortex could power the decision-making part of the brain that figures out what to do about the pain.

“Now that you start to find these areas in the brain that play a role in this, the question is, can we use technology to change that firing pattern of those neurons?” Vanderah said.