A device developed by the NINDS Intramural Research Division to help people with the swallowing disorder dysphagia
has moved one step closer to commercial development. The vibrotactile
device—developed in the laryngeal and speech section of the Medical Neurology Branch by then senior scientist Dr. Christy Ludlow—was recently fully licensed by a private company.
The company, Passy Muir, will further develop
it for eventual commercialization.
|The vibrotactile device shown above was used in previous NIH studies. A more clinical form that is easy to use is being developed. Dr. Christy Ludlow (r) created the vibrotactile device.
“Dr. Ludlow’s device presents extraordinary potential to patients who would otherwise be unable to swallow,” said Laurie Arrants of NINDS’s technology transfer office, which handled
developmental tech transfer and licensing activities along with NIH’s Office of Technology Transfer. “Translating such inventive scientific work to a commercial product made available to patients takes a dedicated scientist, a supportive
institute, a coordinated team of tech transfer and licensing specialists and a qualified commercial company. We hope that the device can reach the market in 3 to 5 years and the patient/public health benefits of Dr. Ludlow’s work will be fully realized.”
The vibrotactile device was designed to improve swallowing and reduce the risk of choking for people who develop chronic swallowing problems
after brain injury such as stroke. While at NINDS, Ludlow—who has been developing the device for 13 years—conducted several studies to perfect it.
One study compared the effects of patients retraining their own swallowing using a vibrotactile
device with an implanted muscle stimulator to find which is better at improving swallowing in people with dysphagia. The device is strapped to the outside of the throat near the larynx and provides sensory stimulation when the user tries to swallow. Study participants were randomized to one of the two device groups.
“Overall most patients in both groups reported
improvement and were able to increase their food intake even though they had not previously
been able to take anything orally for well over a year prior to the study,” said Ludlow, now director of the Laboratory on Neural Bases of Communication and Swallowing at James Madison
University. She and her colleagues are still analyzing data from the study and hope to submit the results soon for publishing.
Dysphagia is a common disorder caused by brain damage following stroke, traumatic
brain injury or tumor removal and is also seen in people with neurodegenerative
disorders such as Parkinson’s disease. People with dysphagia have difficulty swallowing and may experience aspiration, i.e., food or liquid going into the windpipe
while swallowing. Some people may be completely unable to swallow or may have trouble swallowing liquids, food or saliva.
According to Ludlow, people at risk of choking on fluid or food for several weeks or months face a significant risk of aspiration pneumonia, are restricted in their intake by mouth and may need to be fed by a tube. The survival rate in some of these cases is estimated to be only 17 percent after 3 years. The purpose of the vibrotactile device is to increase survival and quality of life by reducing risk of aspiration and improving swallowing function.
Newlin Morgan and George Dold, engineers with the NIMH/NINDS section on instrumentation, were co-inventors of the vibrotactile device and worked with Ludlow and her staff on the initial engineering development. Other co-inventors included former NINDS researchers Drs. Ianessa Humbert, Soren Lowell and Christopher Poletto.
Because the device used in previous NIH studies was a research device, Ludlow says, “a more clinical form of the device that is easy for patients to use needs to be developed.” The next step is to evaluate a more user-friendly version and then test it with patients and speech pathologists.
Since leaving NIH and assuming the JMU post, Ludlow has received an NINDS grant to develop a valid and reliable diagnostic test for spasmodic dysphonia. Spasmodic dysphonia is a neurological disorder affecting the brain control of voice muscles in the larynx, or voice box. Many people go undiagnosed for several years and may undergo unnecessary procedures because they do not have an early, accurate
diagnosis, Ludlow noted.
“We hope that this new diagnostic and assessment procedure will provide methods
to enhance early treatment and research on this poorly understood disorder,” she said.