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NCT05212129 · ClinicalTrials.gov registry record · NA

Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome

A NA study of Postural Orthostatic Tachycardia Syndrome and Functional Gastrointestinal Disorders, sponsored by Medical College of Wisconsin.

Recruiting
Registry status
NA
Development phase
90
Enrollment target
1
Study location

NCT05212129: Recruiting NA study of Postural Orthostatic Tachycardia Syndrome and Functional Gastrointestinal Disorders, sponsored by Medical College of Wisconsin.

NCT05212129 is a NA study of Postural Orthostatic Tachycardia Syndrome and Functional Gastrointestinal Disorders that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 90 participants, below the 9,236-participant average among 11 other Postural Orthostatic Tachycardia Syndrome trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05212129, a NA study of Postural Orthostatic Tachycardia Syndrome and Functional Gastrointestinal Disorders, is actively recruiting participants, sponsored by Medical College of Wisconsin.

RECRUITING
Registry status
NA
Development phase
90 participants
Enrollment target
1
Study location

Study Summary

Hypermobile Ehlers-Danlos Syndrome (hEDS) is a connective tissue disorder characterized by hyperextensible skin, joint hypermobility and additional connective tissue manifestations. For unclear reasons, hEDS is associated with many gastrointestinal (GI) and autonomic nervous system (ANS) complaints such as postural orthostatic tachycardia syndrome (POTS). This study will address the clinical relationship between hEDS/Hypermobile Spectrum Disorders and autonomic regulation and see if there is a benefit of two forms of non-invasive vagal nerve stimulation therapies to reduce GI symptoms in hEDS and POTS. The study will also investigate plausible effects of these nerve stimulation therapies on gastric function and autonomic signaling.

Primary Outcome

Instrument assessing upper gastrointestinal symptoms including symptoms of gastroparesis; score range 0-100 with higher scores indicating worse symptoms

Conditions Studied

Postural Orthostatic Tachycardia Syndrome Functional Gastrointestinal Disorders Autonomic Nervous System Disease Autonomic Nervous System Imbalance Hypermobile Ehlers-Danlos Syndrome

Interventions

  • DEVICE Percutaneous vagal nerve stimulation (pVNS) device
  • OTHER Acoustic vagal nerve stimulation (aVNS) treatment

Study Locations (1)

Wisconsin

  • Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2021-04-05
Est. Completion 2026-12-31
Phase NA
Medical College of Wisconsin

447 total trials

What NCT05212129 shows while recruiting

NCT05212129 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 9,236-participant average among 11 other Postural Orthostatic Tachycardia Syndrome trials with a reported enrollment target (99% lower).

The record links to 5 conditions, with Postural Orthostatic Tachycardia Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Percutaneous vagal nerve stimulation (pVNS) device is the first listed.

NCT05212129 reports a single indexed study location in Wisconsin.

Frequently Asked Questions

What is clinical trial NCT05212129 about?

NCT05212129 is a clinical study titled "Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome". Hypermobile Ehlers-Danlos Syndrome (hEDS) is a connective tissue disorder characterized by hyperextensible skin, joint hypermobility and additional connective tissue manifestations. For unclear reasons, hEDS is associated with many gastrointestinal (GI) and autonomic nervous system (ANS) complaints ...

What is the current status of trial NCT05212129?

This trial is currently recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2021-04-05. Estimated completion is 2026-12-31.

What conditions does trial NCT05212129 study?

This clinical trial studies the following conditions: Postural Orthostatic Tachycardia Syndrome, Functional Gastrointestinal Disorders, Autonomic Nervous System Disease, Autonomic Nervous System Imbalance, Hypermobile Ehlers-Danlos Syndrome.

What interventions are being tested in trial NCT05212129?

The interventions under investigation include: Percutaneous vagal nerve stimulation (pVNS) device (DEVICE), Acoustic vagal nerve stimulation (aVNS) treatment (OTHER).

Who is sponsoring clinical trial NCT05212129?

This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05212129 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Postural Orthostatic Tachycardia Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05212129's enrollment target sits among peer trials

90 5th of 11 higher than 7 of 11 other Postural Orthostatic Tachycardia Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Postural Orthostatic Tachycardia Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05212129

Source: ClinicalTrials.gov NCT05212129, the US trial registry maintained by the National Library of Medicine. NCT05212129 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.