Soterix Medical Inc. Awarded $2.5M NIH Grant to Run Phase-2 Efficacy Trial to Treat Aphasia After Stroke with HD-tDCS.

NEW YORK–(BUSINESS WIRE)– Soterix
Medical, Inc. (SMI), the leading non-invasive neuromodulation
medical technology company, announces the award of a $2.5 million grant
from the National Institute of Neurological Disorders and Stroke to
support a Phase-2 Clinical Trial aimed at establishing the effectiveness
of individualized High-Definition
transcranial Direct Current Stimulation (HD-tDCS ^TM) for
adjunctive treatment of anomia in chronic post-stroke aphasia. The
multi-center, randomized, sham-controlled, double-blind trial includes
collaborators from Georgetown University, University of North Carolina,
Medstar Research Institute, The City College of New York (CCNY) and
University of South Carolina. Additional trial information can be found here.

Aphasia
is an impairment of language, affecting production or comprehension of
speech and the ability to read or write. It is a debilitating long-term
consequence for 1 in 5 stroke cases. For these patients, HD-tDCS,
combined with speech therapy, has the potential to improve language
function. HD-tDCS delivers current to an individually targeted brain
region to enhance plasticity during speech therapy and thus improve
functional outcomes. Individualized targeting is particularly important
in stroke rehabilitation where the presence of brain lesions leads to
drastically altered stimulation pattern. Based on each patient brain
scan (MRI), therapy can be targeted by clinicians to specific viable
brain areas determined with functional MRI, making HD-tDCS, the first
non-invasive individualized neuromodulation technique.

The Phase-2 Clinical Trial follows a successful Phase-1 Clinical Trial
that demonstrated that Soterix Medical’s exclusive Neurotargeting
software could be used to individualize therapy to each patient,
with the goal to boost plasticity in the targeted brain regions. The
hardware system uses patent protected “HD” electrode arrays.

Dr. Abhishek Datta, Scientist and CTO of SMI and Dr. Lucas C. Parra,
Professor of Biomedical Engineering at CCNY will lead the study as
Principal Investigators.

“This grant from the National Institute of Health will advance the
validation of HD- tDCS as the only neuromodulation platform that is
non-invasive, low-intensity, and targeted. Soterix Medical is the
technology leader in non-invasive neuromodulation with a commitment to
enhance the treatment of neuropsychiatric disorders and
neuro-rehabilitation after injury. This trial supports our mission to
translate medical research in neuromodulation to clinical practice.”
said Dr. Datta. “I am very pleased that NIH has funded this extremely
important Phase-2 trial. The full development of this electrical
stimulation platform and the safety outcomes have potentially broader
clinical applicability included motor recovery in stroke and analgesic
effects in central pain,” said Dr. Parra.

CAUTION: tDCS is limited by Federal (or United States) law to
investigational use only.

BACKGROUND: High-Definition tDCS (HD-tDCS)
is an exclusive Neuromodulation technology developed by Soterix Medical
Inc. Invented at The City College of New York, it is the only technology
platform that allows tolerated non-invasive delivery of therapeutic
current to desired brain regions. As a result, HD-tDCS offers potential
for safe and effective treatment of neuropsychiatric disorders not
possible with any other technology. HD-tDCS is made possible through
innovations in electrode design allowing safe and tolerated passage of
current through proprietary “High-Definition” electrodes, individualized
brain current-flow modeling and through patented targeting
algorithms indicating how to place and energize HD-electrodes on the
head.

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