Virtual, Augmented and Medically Extended Reality

Brennan Spiegel, MD, calls the brain a shape-shifting organ. Bombard it long enough with pain signals from somewhere – lower back, head – and the brain will generate its own pain signals.

“If there is pain in the body it will sensitize the nerves. The nerves will fire over and over again,” said Spiegel, who directs Cedar-Sinai’s Clinical and Translational Science Institute in Los Angeles. "We can use opioids to reduce inflammation, but it won’t reduce pain occurrence.”

Virtual reality, he continued, is a time-tested, known intervention that can change how the brain perceives pain. “VR is a top-down approach, used with traditional [pain-healing] approaches to intercept this signal.”

Brennan M. Spiegel, MD, MSHS

The use of VR–Spiegel’s preferred term is medically extended reality, or MXR – and its sister technology, augmented reality–have become more commonplace in the medical device world. The breadth of how and where these technologies are being deployed is remarkable, from easing a woman’s pain when giving birth¹ to a new study looking at how AR can help veterans with post-traumatic stress syndrome.²

Other trials are looking at how these technologies can help those with diseases like cancer, disorders like cerebral palsy and behaviors like smoking cessation.³ Approved devices incorporating VR include diagnostic help to ascertain autism spectrum disorder and to relieve lower back pain.⁴

The FDA has responded to this rapid growth: the agency now has staff dedicated to the review of medical device applications that include augmented and virtual reality incorporated devices. In a statement, the FDA said it will “continue to develop software and digital health technical expertise to provide assistance for premarket submissions that include…Virtual, Mixed, and Augmented Reality (VR/MR/AR)” and other digital health technologies.”

Since 2020, the agency has approved at least 350 devices using artificial intelligence and or deep learning –these are closely connected technologies to the AR/VR realms.⁵

What is also worthy of note are the number of breakthrough designations that the FDA’s Center for Devices and Radiological Health has awarded over the years. In fiscal year 2018, that number was 62; last year, it was 187. These devices have serious, important medical intent: stimulating the vagus nerve for stroke patients during their rehabilitation; a 3-D printed replacement talus for those with avascular necrosis of the ankle joint; and a portable neuromodulation stimulator for patients with multiple sclerosis to help with gait problems.⁵

VR is also being used in surgical training. In its July 2022 Patient Engagement Advisory Committee report, the FDA said VR has “the ability to train surgeons with less need for cadavers, animal models or on-site facilities may open up new opportunities for surgical specialty training in historically marginalized communities that suffer from shortages of specialists.”⁶

A peek at those companies using AR/VR are not exactly household names. But that could change in the future. “We do have some future solutions in the pipeline,” wrote Linh Dinh, digital communications director, GE Healthcare, in an email.

A brief on terminology

For those who grew up with PacMan as opposed to Oculus Quest 2 and are a little confused over which reality does what, a short explanation of both.

Augmented reality uses sensors and cameras to record the user’s surrounding environment, and then its software takes that information and combines it with computer generated information that makes it more valuable. When artificial intelligence is used to create AR software, surgeons, for example, can find lesions they might not otherwise have found. ⁷

Ophthalmologists are particularly interested in AR in treating low vision, amblyopia and visual field defects caused by stroke or glaucoma.⁸

A VR-based device is approved to help the most common problem there is: lower back pain.⁹

“We are working with evidence-based approaches,” said Matthew Stoudt, cofounder and CEO of AppliedVR, whose product, Relievrx, (formerly Easevrx) received breakthrough designation in 2020 and approved last November. This VR-based product is approved for use on lower back pain.

Matthew Stoudt, cofounder and CEO of AppliedVR.

The opioid epidemic has been a major motivator to design a non-pharmaceutical therapy to help with pain, he said. Those he is working with, he said, including physicians from Stanford and Cedars-Sinai, are “motivated to get rid of the opioid epidemic. “We do believe in strong advocacy to find non pharmaceutical solutions,” said Stoudt. The software, he said, was developed by AppliedVR with those key pain researchers. The hardware was developed by Pico.

The company is continuing with more clinical studies of its product. “We have to prove to the doctors it works, and then we can get the payers on board.”

Some doctors besides Spiegel and his team already do. Spiegel, who has published numerous articles and a book about MXR, said about 200 hospitals, including Cedars-Sinai, are using MXR in some way to treat patients. So far, his hospital has treated more than 3,000 patients.

Issues and studies

In a recent report the FDA discussed possible issues with the use of VR/AR,¹⁰ mainly because the technology has not been in use long enough to ascertain if there are any serious issues with it, like overuse. Spiegel said Cedars-Sinai monitors for dependency and addiction, mainly be seeing how often patient uses the headset. Patients are likely to get nauseous if they use it for more than 20 minutes at a time. “It has an anti-abuse effect,” he said.

Christine Bahls is a freelance writer for medical, clinical trials, and pharma information.

References

1. Wong MS, Spiegel BMR, Gregory KD. Virtual Reality Reduces Pain in Laboring Women: A Randomized Controlled Trial. Am J Perinatol. 2021 Aug;38(S 01):e167-e172. doi: 10.1055/s-0040-1708851. Epub 2020 Jun 2.
2. CAREN vs Augmented Reality 3MDR for PTSD PTSD: A Randomized Controlled Trial (CARE4PTSD) Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT05244564?term=augmented+reality&recrs=a&type=Intr&draw=3&rank=20
3. Clinical trials.gov https://clinicaltrials.gov/ct2/results?cond=&term=augmented+reality&type=Intr&rslt=&recrs=d&age_v=&gndr=&intr=&titles=&outc=&spons=&lead=&id=&cntry=&state=&city=&dist=&locn=&rsub=&strd_s=&strd_e=&prcd_s=&prcd_e=&sfpd_s=&sfpd_e=&rfpd_s=&rfpd_e=&lupd_s=&lupd_e=&sort=
4. Programmatic Accomplishments. Center for Devices and Radiological Health. 2021. https://www.fda.gov/media/155793/download
5. Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Deviceshttps://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices
6. U.S. Food and Drug Administration. Augmented reality and virtual reality medical devices. Executive summary for the Patient Engagement Advisory Committee meeting. July 12-13, 2022.
7. Cem Dilmegani. 13+ AI Applications & Use Cases in Augmented Reality in 2022. AI Multiple. https://research.aimultiple.com/ar-ai/#9-ai-ar-applications-in-industry Sept. 13, 2022.
8. Li T, Li C, Zhang X, Liang W, Chen Y, Ye Y, Lin H. Augmented Reality in Ophthalmology: Applications and Challenges. Front Med (Lausanne). 2021 Dec 10;8:733241. doi: 10.3389/fmed.2021.733241.
9. FDA press release. FDA Authorizes Marketing of Virtual Reality System for Chronic Pain Reduction. Nov. 16, 2021.https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-virtual-reality-system-chronic-pain-reduction
10. Executive Summary for The Patient Engagement Advisory Committee Meeting Augmented Reality and Virtual Reality Medical Devices. July 12 – 13, 2022.https://www.fda.gov/media/159709/download