NeuroMetrix Reports that Quell® Technology is to be Evaluated for Neuromyelitis Optica Spectrum Disorder (NMOSD) in a Random...
June 15 2021 - 9:00AM
NeuroMetrix, Inc. (Nasdaq: NURO) today announced that Quell
technology will be used in a double-blinded, randomized,
sham-controlled trial to determine whether transcutaneous
electrical nerve stimulation (TENS) is an effective, acceptable and
feasible method of pain relief in patients with NMOSD. The
principal investigator is Michael Levy, M.D., Ph.D., Director, NMO
Clinic and Research Laboratory, Massachusetts General Hospital,
Boston, MA.
NMOSD is a rare, chronic relapsing autoimmune disease of the
central nervous system that targets the optic nerves and spinal
cord and can cause paralysis and vision loss. Central neuropathic
pain (CNP), characterized by chronic burning, shooting or tingling
sensations in the arms, torso and legs, occurs in many cases. CNP
can be debilitating and current pharmacological treatments have
limited efficacy and significant side effects.
TENS is a safe, non-pharmacologic pain relief approach. It has
been shown to be effective in some forms of neuropathic pain, but
has not been extensively evaluated for NMOSD. Quell technology is
an advanced TENS platform that is enabled by a proprietary
neurostimulation microchip that provides flexible, precise,
high-power nerve stimulation in small wearable devices. Quell
supports Bluetooth® low energy (BLE) to communicate with mobile
applications. The trial will use a modified Quell device and mobile
app that allow for an alternative electrode placement and
stimulation pattern. The same system is being used in a large,
NIH-funded pragmatic clinical trial of TENS for fibromyalgia.
The current trial will enroll 46 patients with NMOSD. The
subjects will be randomized to an active or sham Quell device for 4
weeks. All subjects will then proceed into a 4-week open-label
active treatment phase. The primary outcome measure is the baseline
to 4-week change in pain intensity using the 11-point numerical
pain scale. Study details are available here.
"We are pleased to support Dr. Levy and his colleagues in this
clinical trial. NMOSD is a disabling disease without safe and
effective treatment options," said Shai N. Gozani, M.D., Ph.D.,
President and CEO of NeuroMetrix. "This rigorous randomized
controlled trial will add to the growing body of clinical data on
the utility of Quell technology in chronic pain conditions with a
neuropathic pain component. There are significant unmet clinical
needs in the treatment of neuropathic pain that Quell may be able
to eventually address.”
Note: The use of Quell for NMOSD and neuropathic pain is
investigational only. The safety and effectiveness for these
purposes has not been reviewed by the United States Food and Drug
Administration.
About NeuroMetrix
NeuroMetrix is an innovation-driven company focused on the
development and global commercialization of non-invasive medical
devices for the diagnosis and treatment of pain and neurological
disorders. The Company has three commercial products. DPNCheck® is
a diagnostic device that provides rapid, point-of-care detection of
peripheral neuropathies. ADVANCE® is a diagnostic device that
provides automated, in-office nerve conduction studies for the
evaluation of focal neuropathies. Quell® is a wearable
neurostimulation device indicated for symptomatic relief of lower
extremity chronic pain that is available over-the-counter. For more
information, visit www.NeuroMetrix.com.
Source: NeuroMetrix, Inc.
Thomas T. HigginsSVP and Chief Financial
Officer781-314-2761neurometrix.ir@neurometrix.com
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