The intervention we are studying is called transcutaneous auricular neurostimulation
(tAN). tAN is simply electrical nerve stimulation administered at the ear which targets
both the auricular branch of the vagus nerve (ABVN) and the auricular branch of the
trigeminal nerve (ATN). tAN will be administered using a the Spark Sparrow Ascent System
that PI Dr. Badran has used in a prior MUSC IRB-Approved Neonatal study and has also been
approved for human research applications as a non-significant risk investigational
device. The Sparrow Ascent tAN device, as of June 21, 2023, has received FDA 510(k)
clearance (K230796) and is indicated as a transcutaneous nerve field stimulator that is
intended to be used in both the inpatient and outpatient setting for patients
experiencing opioid withdrawal. However in this paradigm we will be using the device as
an research device in individuals with EDS, with identical stimulation guidelines that
are prescribed and used in the FDA indicated manner.
The Sparrow Ascent tAN System is intended to stimulate branches of the vagus and
trigeminal nerves on and/or around the ear. This is based on the first FDA-cleared device
that non-invasively stimulates both the vagus and trigeminal nerves. tAN has been shown
in multiple clinical trials to reduce pain associated with opioid withdrawal in adults
and neonates. The Sparrow Ascent System utilizes a flexible earpiece with embedded
hydrogel electrodes that adhere to the skin, the earpiece is disposable after use, and
delivers a non-opioid and non-pharmacological therapy. The system is capable of fully
customizing stimulation parameters to match each participants' therapeutic requirements.
Stimulation parameters on the Patient Controller can be using the interface on the
Patient Controller. The Patient Controller delivers electrical stimulation to the
earpiece via a removable cable. Patients can modulate therapy intensity by pressing
up/down buttons and check therapy status with LED lights. The Sparrow earpiece is applied
for each patient to position the electrodes to stimulate three key dermatome regions.
These regions are adjacent to several cranial nerves (V, VII, IX, X) and occipital
nerves. In particular, the electrodes are located on the cymba concha, on the
temporomandibular join region, just anterior to the tragus, and behind the auricle.
In this study, participants will be randomized to receive twice daily (1hr per session)
either active- or sham tAN treatment outlined below.
All participants will be randomized to receive either active or sham tAN in the first
blinded phase of this trial (2 weeks). Afterwards, all participants, regardless of
stimulation condition, will receive 2 additional weeks of active tAN in an open-label
arm. Thus participants may receive one of the following: