Clinical Trials and Medical Devices

Feedback from readers has made us realize that many people think clinical trials are only for the desperate: Either those who are looking for a cure of last resort or those who need money so badly they’re willing to be human guinea pigs. While it is true that many participate in clinical trials for those reasons, the real purpose of clinical trials is to gather medical knowledge, which often leads to new treatments; for that reason, clinical trials are of wide-spread value. Of especial interest to seniors, trials are held for devices, as well as medications.

If you participate in a clinical trial, nothing like this will happen. Image courtesy: CuddlyCavies

If you participate in a clinical trial, nothing like this will happen. Image courtesy: CuddlyCavies

The FDA’s “basic” definition of a medical device is nearly 130 words long, so it’s easier to go with what they say it isn’t:  “If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug.”

In other words, many devices can be non-invasive. They can be new types of monitors and sensors, some of which may be implanted under the skin, but many of which may simply be worn over clothing. They can also be assistive technologies that range from elaborate exoskeltons and other robotics to training systems for fall prevention.

Participating in a clinical trial, like donating blood or bone marrow, can be a selfless gift to people you’ll never meet, or a way to potentially help yourself or family members who suffer from particular conditions. If you are interested in discovering the wide-range of clinical trials, please check clinicaltrials.gov, which will let you search for trials by various terms, including topic and location.

Re-thinking fall prevention

The poisonous plants of the decorating world. Beautiful, but deadly.

Area Rugs, the poisonous plants of interior decoration. Like Oleander, beautiful but deadly.

We trust that you all know that if you’re concerned with fall prevention, you don’t want area rugs in your home. But even if, like Sleeping Beauty’s parents and spindles, you eliminate every area rug you can, the world is still full of curbs, ice and other risks, so your best defense is strengthening your own balance. To that end, Clive Pei, a professor in the Department of Physical Therapy at the  University of Illinois in Chicago, is making seniors fall.

The idea, as explained in this AP article with optional video, is a new take on balance-training: Instead of general muscle conditioning, it lets people practice catching themselves before a fall. Participants train on a mechanized version of an area rug: a moving walkway that is programmed to slide and cause falls. Because they are wearing safety harnesses, they never fall far enough to injure themselves, but the repeated falling motion lets them continuously reinforce the instinctive movements to stop a fall. The study, located in Chicago, is currently recruiting participants.

Of course, you could just buy a cane, but yeah, we know, makes ya look old. Well, if you fear such an accessory might make you seem less than fully virile, we found (oh Internet!) one made from, er, blush, “the reproductive organ of a bull.” For the ladies, bling it on!

Potential Relief for Cluster Headaches in Clinical Trials

Cluster headaches are in the news because Harry Potter star Daniel Radcliffe has the misfortune to suffer from them. While the “typical” patient may be a young man like Radcliffe, cluster headaches can present for the first time in mid-life or even advanced old age in both men and women (up to four percent of elderly patients in headache clinics). Fortunately, doctors are now testing an implantable neurostimulator to manage the pain.

“Cluster headache is one of the most severe and disabling chronic pain conditions known to humankind,” says Dr. Ali Rezai, director of the Neuroscience program at Ohio State’s Wexner Medical Center. Working with device manufacturer Autonomic Technologies, Inc., he and his colleagues are developing a neurostimulator  system to block pain signals from the sphenopalatine ganglion (SPG). The normal role of this cluster of nerves is simply to allow the face to be sensitive to touch and other sensations, but it can also be the source of excruciating pain, resulting from conditions ranging from shingles to migraines and cluster headaches.

One of the most common current treatments is an SPG block, in which anesthetic is injected near the SPG. By contrast, this new approach requires surgery to implant a stimulator, which patients activate with a handheld controller at the first sign of pain.

The system has been successfully deployed in Europe, but has not yet been approved in the United States. Currently,  Ohio State is enrolling cluster headache patients for an ongoing clinical trial. A migraine trial with the device is open in Europe.

[youtube https://www.youtube.com/watch?v=X1GdGgMGEZM]

GaitAid in Clinical Trial for Falls

The training device GaitAid is already being used to help improve locomotion for those with Parkinson’s disease and other neurological disorders. Now, a clinical trial is enrolling subjects to test whether it might also help prevent falls in the elderly. According to the CDC, falls are “the leading cause of both fatal and nonfatal injuries” in older adults.

GaitAid is actually a miniature augmented reality system, created by Technion computer science professor Yoram Baram. He had seen a news report describing how Parkinson’s patients were able to walk much more naturally on tile floors, with their high contrast patterns, than on monochrome floors. With his experience developing virtual reality systems for NASA, he set about creating a simple VR system that could reproduce the effect.

The GaitAid headpiece looks more like stylish sunglasses than a clunky VR visor; it connects to a pager-sized unit whose motion sensors dynamically superimpose a black-and-white tile pattern as the patient walks along. Headphones amplify the patient’s steps, giving feedback to re-enforce a proper a proper rhythm.

Currently, GaitAid, available for $1995 online, is being used by patients to practice stride length and rhythm in order to restore a more normal walking pattern and reduce “freezing,” a Parkinson’s condition in which the legs don’t respond to the brain’s signal to walk.

Now, Technion and Weill Medical College of Cornell University in New York City have teamed up to determine whether GaitAid might also help in fall prevention. The trial is extremely simple: Participants will be asked to walk without aid, then walk using GaitAid, and then asked to walk again, unaided. Researchers will evaluate whether the brief time using GaitAid made a discernible, helpful difference.

Information on participating in the trial can be found here.

[youtube http://www.youtube.com/watch?v=ZVIKRYNyiug#t=384]