January 07, 2022 – A portable neuromodulation device can put the user in a meditative state with the potential to ease chronic pain, according to its teenage inventors.

The Fluxwear Shift pulses electromagnetic energy into the user's brain, synchronizing neurons in patterns that resemble meditation, said Kamran Ansari, the company's 16-year-old CEO.

Kamran Ansari and his sister, Nadia Ansari, introduced the product at CES 2022, the annual trade show of the Consumer Technology Association.

Yes, you read that right: 16 years old. Kamran Ansari, a math prodigy who studied calculus in middle school, set to work on the device after his sister, Nadia Ansari, 18, began to experience pain from Guillain-Barré syndrome in July 2017. The pain was so severe that she had to stop her high school studies.

Nadia Ansari had tried medication and various other treatments for pain, eventually turning to neuromodulation – a method of altering nerve activity via electrical stimulation. The large neuromodulation devices used to treat her sometimes provided relief, but they were awkward and the effects inconsistent, she said.

"What I found to be the most effective was pulsation magnetic field, or PMF," said Kamran Ansari. "I found that a lot of the devices that we would bring home for Nadia to use were a little bit more clunky or so hard to use that they didn't allow her to use it portably. My goal became creating a PMF device that allowed her to be comfortable to go to school and do all the things that she wanted to do while receiving therapy."

He designed a device that could be built into a cadet-style cap, delivering low levels of energy through a high number of emitters to create multidirectional fields, and thus increase "synchronicity or functional connectivity of different brain regions," a condition found in profound meditation, he says. "We found this device replicates that effect in 25 minutes of use."

Nadia Ansari began using the device in October 2020 and by March 2021 was feeling much better. "I was able to go back to a lot of physical activity," she said. "Before, I would have trouble just walking around. I had to go undergo a bunch of diet changes to help with the pain, but I was able to go back to eating everything I could before. And I will go back to school to full time."

Kamran Ansari has tested the product on other patients, measuring changes in electroencephalography. The company has also launched clinical trials to see if it can document effects on pain and anxiety, he said. It has not yet published any data.

For now, the device has Class I clearance from the FDA, which covers devices that "present minimal potential for harm to the user and are often simpler in design." Fluxwear is currently promoting the Shift as a meditation aid, not as a treatment for pain or any other medical condition.

Tales of a teenage CEO inventing a cool new product are always fun, but Ansari is serious about Fluxwear and the effectiveness of the company's first product. As they developed the Shift, the siblings received guidance from a group of experts, including Christine Kraus, PhD, a clinical neuropsychologist and associate clinical professor at the University of California, Irvine; Ali Elahi, MD, a Newport Beach neurologist with expertise in repetitive transcranial magnetic stimulation; and Shaista Malik, MD, PhD, MPH, a UCI professor of medicine and executive director of the Susan Samueli Integrative Health Institute.

While neuromodulation is not new, the exact mechanism of the process is not yet determined, and there are many forms that differ by the type of energy and the area of the brain targeted, but some have proven effective in clinical trials for pain, said Sarah Prinsloo, PhD, an assistant professor of palliative, rehabilitation and integrative medicine in the Department of Neurosurgery at the University of Texas MD Anderson Cancer Center in Houston.

"[Neuromodulation] is just something patients can have in their toolbox to help treat their symptoms without adding another medication, especially in populations that are already pretty heavily medicated, such as for pain," Prinsloo said. "I get really nothing but positive feedback from physicians."

Transcranial magnetic stimulation can cause side effects, including seizures, but those occur mostly with the large, powerful devices used in medical clinics, said Prinsloo, who has no connection to the Ansaris or knowledge of the Shift other than the information from the company website. Fluxwear so far reports no side effects with their device.

For now, the company is collecting preorders for the Shift. It also offers weekly demonstrations open to the public at its offices in Irvine, California, said Nadia Ansari, also the company's chief operating officer. "We want people to actually try it and see how it works for them before they buy it," she said.

The Ansaris plan to commercialize the Shift in spring of this year. In the meantime, they will continue their studies at their high school in Newport Beach, CA.