Hypermobile Ehlers-Danlos SyndromehEDS-tANNCT06105541
Hypermobile Ehlers-Danlos Syndrome - Transcutaneous Auricular Neuromodulation
A study testing Transcutaneous Auricular Neurostimulation in people with Hypermobile Ehlers-Danlos Syndrome and Hypermobile Spectrum Disorder, run by Medical University of South Carolina at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypermobile Ehlers-Danlos Syndrome, Hypermobile Spectrum Disorder, Ehlers-Danlos Syndrome
- What is being tested?
- Transcutaneous Auricular Neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2023to 4 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- MRI-contraindicated implanted medical devices;
- pregnant
- history of seizures
- prior history of trauma or damage to ear
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: At-Home Transcutaneous Auricular Neuromodulation for Hypermobile Ehlers Danlos Syndrome
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.
Read the 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
- Being tested
- Transcutaneous Auricular Neurostimulation
- Medical subject headings
- Ehlers-Danlos syndrome type 3, Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular NeurostimulationDevice
Transcutaneous Auricular Neurostimulation (tAN) is a wearable, electrical stimulation device that delivers electricity to specific parts of the human ear.
| Study group | Role | What they receive |
|---|---|---|
| 2 Weeks Sham tAN followed by 2 Weeks Active tAN | Experimental | Participants will be randomized to receive 2 weeks of at-home, self-administered sham Transcutaneous Auricular Neurostimulation (tAN), followed by 2 weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN). Receives: Device: Transcutaneous Auricular Neurostimulation |
| Four Weeks of Active Transcutaneous Auricular Neurostimulation | Experimental | Participants will be randomized to receive 2 weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN), followed by 2 additional weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN) Receives: Device: Transcutaneous Auricular Neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ehlers-Danlos Syndrome Symptom Battery
The investigators have created an Ehlers-Danlos Syndrome Symptom Battery that measures a variety of different primary and secondary symptoms associated with Ehlers-Danlos Syndrome, including: Pain, Fatigue, Sleep, Anxiety, Depression, Quality of Life, and Gastrointestinal issues
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start5 Jul 2023
- Primary completion4 Feb 2026
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermobile Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Borckardt, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105541
- Sponsor's protocol ID
- Pro00128818
- Acronym
- hEDS-tAN
- Status last verified
- Oct 2025
- First submitted
- 9 Aug 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At-Home Transcutaneous Auricular Neuromodulation for Hypermobile Ehlers Danlos Syndrome
- ClinicalTrials.gov ID
- NCT06105541
- Acronym / sponsor ID
- hEDS-tAN / Pro00128818
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| 2 Weeks Sham tAN followed by 2 Weeks Active tAN | Experimental | Device: Transcutaneous Auricular NeurostimulationParticipants will be randomized to receive 2 weeks of at-home, self-administered sham Transcutaneous Auricular Neurostimulation (tAN), followed by 2 weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN). |
| Four Weeks of Active Transcutaneous Auricular Neurostimulation | Experimental | Device: Transcutaneous Auricular NeurostimulationParticipants will be randomized to receive 2 weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN), followed by 2 additional weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- MRI-contraindicated implanted medical devices;
- pregnant
- history of seizures
- prior history of trauma or damage to ear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular NeurostimulationTranscutaneous Auricular Neurostimulation (tAN) is a wearable, electrical stimulation device that delivers electricity to specific parts of the human ear. | Device | 2 Weeks Sham tAN followed by 2 Weeks Active tAN, Four Weeks of Active Transcutaneous Auricular Neurostimulation |
Primary outcome
Ehlers-Danlos Syndrome Symptom Battery
Time frame: 16 weeks
The investigators have created an Ehlers-Danlos Syndrome Symptom Battery that measures a variety of different primary and secondary symptoms associated with Ehlers-Danlos Syndrome, including: Pain, Fatigue, Sleep, Anxiety, Depression, Quality of Life, and Gastrointestinal issues
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Neurostimulation in people with Hypermobile Ehlers-Danlos Syndrome and Hypermobile Spectrum Disorder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ehlers-Danlos Syndrome Symptom Battery (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.