Trigeminal Nerve Stimulation is an
experimental new therapy for the treatment of seizures. The
development of the stimulator was modeled after the Vagus
Nerve Stimulator, an FDA approved, implanted device that
provides regular electrical stimulation to the Vagus pathway.
The Trigeminal Nerve Stimulator (TNS) also provides regular
electrical stimulation along a similar pathway; however it
is minimally invasive and can be applied to both sides of
the nervous system. Currently, the TNS is worn externally,
fastened with a belt on the head with electrodes located
near the nose under the cheek bone or above the eye. As safety
and efficacy of the device is established, it is anticipated
that an implanted, internal device will be used.
The LSU Epilepsy
Center of Excellence is sponsoring a short-term trial
of the safety and feasibility of the Trigeminal Nerve Stimulator.
In this preliminary
study, the device will be evaluated for its effects on the EEG recorded
from
scalp and intracranial electrodes in persons being evaluated for epilepsy
surgery. Consequently, the only persons eligible to participate
are those already scheduled
for 24-hour video/EEG monitoring with intracranial and scalp electrodes
as part of a presurgical evaluation.
However, the LSU Epilepsy
Center of Excellence is poised to join a NIH-sponsored,
multi-site study of the long-term safety and feasibility
of the TNS.
Upon
approval of this investigation, persons with epilepsy who have frequent
seizures and may
want to pursue surgical intervention (VNS implant, epilepsy surgery)
will be invited to volunteer for a preliminary safety and
efficacy study of the
external
version of the Trigeminal Nerve Stimulator. (If you are interested in participating in this research study,
please e-mail the Center at epicenter@lsuhsc.edu.)
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