In case you want your doctor to use this to treat your ataxic gait.
What is Ataxic Gait?
Ataxic gait is often characterized by difficulty walking in a straight line, lateral veering, poor balance, a widened base of support, inconsistent arm motion, and lack of repeatability. These symptoms often resemble gait seen under the influence of alcohol.
If you want to evaluate your ataxia yourself in violation of doctor's purview, here you go.
Scale for Assessment and Rating of AtaxiaThe latest here:
Novel Device OK'd to Treat MS Gait Deficits - Tongue stimulator generates pulses to combat ataxia
A novel stimulator device to treat gait deficits in multiple sclerosis (MS) patients with mild to moderate symptoms earned a nod from the FDA Friday.
The device, known as the Portable Neuromodulation Stimulator (PoNS),
generates electrical pulses on the tongue to stimulate trigeminal and
facial nerves to treat motor deficits. To be available by prescription,
it is to be used only as part of a supervised therapeutic exercise
program in MS patients 22 and older, the agency said. The FDA authorized
the device through its "de novo" premarket review pathway for new
devices posing low to moderate risks for adverse effects.
"MS
is one of the most common neurological diseases in young adults.
Today's authorization offers a valuable new aid in physical therapy and
increases the value of additional therapies for those who live with MS
on a daily basis," Christopher Loftus, MD, acting director of the Office
of Neurological and Physical Medicine Devices in the FDA's Center for
Devices and Radiological Health, said in a statement.
Most people with MS experience their first symptoms between the ages
of 20 and 40 and the disease occurs more frequently in women than in
men. MS can cause a variety of symptoms, including problems with walking
and balance.
The PoNS device delivers mild neuromuscular electrical stimulation to
the dorsal surface of the patient's tongue. A control unit, worn around
the neck, sends signals to a mouthpiece the patient holds lightly in
place with their lips and teeth. A therapist can view usage data later
to identify "potential areas of missed or shortened sessions," the FDA
noted.
Two
clinical studies underpinned the agency's favorable review. One
involved 20 MS patients with gait deficits (10 who used PoNS; 10 who
used a sham device), the PoNS group showed "statistically significant
and clinically significant" improvement in Dynamic Gait Index (DGI)
scores at 14 weeks not seen in controls, the FDA said.
The other study, in 14 patients, demonstrated improvements from
baseline in sensory organization task scores (but not in DGI scores) at
14 weeks. No serious safety adverse events were reported in the clinical
studies or retrospective analysis of real-world data.
The PoNS device should not be used by patients with penetrating brain
injuries, neurodegenerative diseases, oral health problems, chronic
infectious diseases, unmanaged hypertension or diabetes, pacemakers, or a
history of seizures, the FDA cautioned. "Because the PoNS device
delivers electrical stimulation directly to the surface of the tongue,
precautions for use are similar to those for transcutaneous electrical
nerve stimulation," the agency said. Electrical stimulation should not
be used if there is an active or suspected malignant tumor, near recent
bleeding or open wounds, or in areas that lack normal sensation. The
PoNS device has not been tested on and should not be used by people
under age 22, who are pregnant, or who are sensitive to nickel, gold, or
copper.
This was device maker Helius Medical's second attempt to win FDA authorization; the agency rejected the PoNS device
in 2019 when the company sought clearance through the less rigorous
510(k) pathway, though it had been approved in Canada. It had been
featured extensively in the media after former television host Montel Williams promoted the device in 2016, which he used to treat his MS symptoms.
The latest here:
Novel Device OK'd to Treat MS Gait Deficits - Tongue stimulator generates pulses to combat ataxia
A novel stimulator device to treat gait deficits in multiple sclerosis (MS) patients with mild to moderate symptoms earned a nod from the FDA Friday.
The device, known as the Portable Neuromodulation Stimulator (PoNS), generates electrical pulses on the tongue to stimulate trigeminal and facial nerves to treat motor deficits. To be available by prescription, it is to be used only as part of a supervised therapeutic exercise program in MS patients 22 and older, the agency said. The FDA authorized the device through its "de novo" premarket review pathway for new devices posing low to moderate risks for adverse effects.
"MS is one of the most common neurological diseases in young adults. Today's authorization offers a valuable new aid in physical therapy and increases the value of additional therapies for those who live with MS on a daily basis," Christopher Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health, said in a statement.
Most people with MS experience their first symptoms between the ages of 20 and 40 and the disease occurs more frequently in women than in men. MS can cause a variety of symptoms, including problems with walking and balance.
The PoNS device delivers mild neuromuscular electrical stimulation to the dorsal surface of the patient's tongue. A control unit, worn around the neck, sends signals to a mouthpiece the patient holds lightly in place with their lips and teeth. A therapist can view usage data later to identify "potential areas of missed or shortened sessions," the FDA noted.
Two clinical studies underpinned the agency's favorable review. One involved 20 MS patients with gait deficits (10 who used PoNS; 10 who used a sham device), the PoNS group showed "statistically significant and clinically significant" improvement in Dynamic Gait Index (DGI) scores at 14 weeks not seen in controls, the FDA said.
The other study, in 14 patients, demonstrated improvements from baseline in sensory organization task scores (but not in DGI scores) at 14 weeks. No serious safety adverse events were reported in the clinical studies or retrospective analysis of real-world data.
The PoNS device should not be used by patients with penetrating brain injuries, neurodegenerative diseases, oral health problems, chronic infectious diseases, unmanaged hypertension or diabetes, pacemakers, or a history of seizures, the FDA cautioned. "Because the PoNS device delivers electrical stimulation directly to the surface of the tongue, precautions for use are similar to those for transcutaneous electrical nerve stimulation," the agency said. Electrical stimulation should not be used if there is an active or suspected malignant tumor, near recent bleeding or open wounds, or in areas that lack normal sensation. The PoNS device has not been tested on and should not be used by people under age 22, who are pregnant, or who are sensitive to nickel, gold, or copper.
This was device maker Helius Medical's second attempt to win FDA authorization; the agency rejected the PoNS device in 2019 when the company sought clearance through the less rigorous 510(k) pathway, though it had been approved in Canada. It had been featured extensively in the media after former television host Montel Williams promoted the device in 2016, which he used to treat his MS symptoms.
