CAMBRIDGE, Mass.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/Enobio?src=hash” target=”_blank”gt;#Enobiolt;/agt;–At the recent American Epilepsy Society Annual Meeting in New Orleans,
Neuroelectrics Corporation presented positive results from its clinical
trial treating patients with drug resistant epilepsy with Starstim™, a
device that uses mild electric currents applied on the scalp to calm
abnormal activity of the brain. Of the seventeen patients that completed
the study, treatment with Neuroelectrics’ Starstim™ device resulted in
a reduction in seizure frequency of at least 40% from baseline in 75% of
the patients, measured eight weeks after treatment. Also, no
device-related adverse events were reported during the study.
Neuroelectrics sponsored the FDA-approved investigational device study
of its Starstim™ product (NCT02866240) at Boston Children’s Hospital,
with adult patients being referred from nearby Beth Israel Deaconess
Medical Center. A parallel study following the same protocol was
conducted at the National Institute of Neurology and Neurosurgery in
All patients enrolled in the study had not responded to at least two
anti-epileptic medications, and for many the next step would be brain
surgery to resect the region of the brain where the seizures originate.
The treatment protocol used 20 minutes of daily stimulation applied for
10 days times over two weeks, followed by an eight-week monitoring
period to measure seizure frequency.
According to Co-Principal Investigator Alexander Rotenberg, MD, PhD,
Associate Professor of Neurology at Boston Children’s Hospital and
Harvard Medical School:
“We and our patients are delighted to have a non-invasive and
non-pharmacologic option for those whose seizures have not been
controlled by drugs or by surgery. Our patients and families have seen
clear improvements in well-being and quality of life.”
POTENTIAL IMPACT ON EPILEPSY PATIENTS
Sixty million patients – approximately 1% of the population worldwide –
live with epilepsy. Nearly one in three do not have their seizures well
controlled by medications. Neuroelectrics’ Starstim™ represents a
non-surgical alternative for seizure control for many of these patients.
In particular, this therapy has the potential to be used for both
patients who are not candidates for epilepsy surgery, and patients who
have undergone epilepsy surgery but continue to have seizures.
STARSTIM™: PRECISION, NON-INVASIVE NEUROMODULATION
Neuroelectrics’ Starstim™ employs a novel form of non-invasive
neuromodulation called transcranial current stimulation (tCS)
to deliver mild electrical currents to the brain. Neuroelectrics’
proprietary Precision-tCS™ technology develops a personalized
stimulation protocol to target the specific areas of the patient’s brain
where the seizures originate, as identified by the treating neurologist.
The Starstim™ device is worn for 20 minutes per day, and there is no
penetration of the brain or skin.
Ana Maiques, Neuroelectrics CEO, said:
“We are pleased that this clinical study has demonstrated the safety and
efficacy of Starstim™ in treating epilepsy. We are proud of having
conducted the first FDA-sanctioned clinical trial in transcranial
current stimulation in any indication, positioning
Neuroelectrics as the leader in developing an option for patients that
employs this powerful therapeutic brain stimulation technology.”
Partial funding for this program was provided under the Massachusetts
Life Sciences Center (MLSC) Cooperative Research Matching Grants.
Neuroelectrics develops therapies to treat brain disorders, combining
proprietary hardware, AI and machine learning. The company’s lead
therapy product is Starstim™, is a completely non-invasive
neuromodulation system that offers benefits comparable to surgically
implanted devices. Neuroelectrics also sells Enobio™, an FDA-cleared,
completely wireless EEG. Founded in 2011 in Barcelona, Neuroelectrics
has sold its research use products to over six hundred institutions
worldwide, and aims to become the world leader in digital brain
The attached photo shows Neuroelectrics’ Starstim™ device worn under a
“mouse cap” used with some of our pediatric patients.
Ana Maiques, CEO