Clinical trial NCT06105541: Hypermobile Ehlers-Danlos Syndrome - Transcutaneous Auricular Neuromodulation
Official title: At-Home Transcutaneous Auricular Neuromodulation for Hypermobile Ehlers Danlos Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypermobile Ehlers-Danlos Syndrome
Hypermobile Spectrum Disorder
Ehlers-Danlos Syndrome
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two paralell groups:

Group 1: Double-blind phase Active, Open-label phase Active Group 2: Double-blind phase Sham, Open-label phase Active
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

* Participants who meet the 2017 diagnostic criteria for hEDS or HSD4-5 with persistent symptoms in at least two of the domains to be followed during the intervention (pain, fatigue, sleep, anxiety, depression, quality of life, GI function, autonomic function and immune function)
* Mentally capable of reading, writing, giving consent, and following instructions

Exclusion Criteria:

* MRI-contraindicated implanted medical devices;
* pregnant
* history of seizures
* prior history of trauma or damage to ear

Primary outcomes:
measure: Ehlers-Danlos Syndrome Symptom Battery
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: