Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06105541 |
Other study ID # |
Pro00128818 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 5, 2023 |
Est. completion date |
July 1, 2025 |
Study information
Verified date |
October 2023 |
Source |
Medical University of South Carolina |
Contact |
Catherine Lewan, DPT |
Phone |
843-792-9414 |
Email |
lewan[@]musc.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Investigate whether at-home transcutaneous auricular VNS (tAN: transcutaneous auricular
neurostimulation) improves a battery of nine key physical and psychological symptoms of a
group of hEDS (Hypermobile Ehlers-Danlos Syndrome & Hypermobile Spectrum Disorder) patients
(n=30) using a randomized, double blind, sham controlled design. The study team will collect
clinical measures at baseline, after a two-week double-blind intervention phase, after a
following two-week open-label phase and finally at three months post intervention. The study
team will test patients in the following domains: pain, fatigue, sleep, anxiety, depression,
quality of life, GI function, immune function and autonomic function.
Description:
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:
- 2 weeks active tAN followed by an additional 2 weeks of active tAN
- 2 weeks sham tAN followed by an additional 2 weeks of active tAN