Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT05776251
Status:
RECRUITING
Last Update Posted:
2025-10-22
First Post:
2023-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
taVNS for Persistent Symptoms From Lyme Disease
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Persistent Symptoms From Lyme Disease: a Feasibility, Tolerability, and Safety Study
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is one of the first studies to investigate a non-antibiotic approach to the treatment of symptoms that persist after antibiotic treatment for Lyme disease (PTLS). Transcutaneous auricular vagus nerve stimulation (taVNS) offers the potential of being an effective and non-toxic approach to reduce the burden of multisystem symptoms in patients with PTLS. This study seeks to address an important goal: to assess the safety, feasibility, and tolerability of a new non-invasive, non-pharmacologic treatment for patients with symptoms that persist despite prior antibiotic treatment for Lyme disease.
Detailed Description:
Musculoskeletal pain, fatigue, and cognitive and mood problems are common persistent disabling symptoms among individuals with post-treatment Lyme Disease. Each year in the United States, approximately 476,000 individuals are newly diagnosed with Lyme disease and 10-20% of these go on to have persistent or relapsing symptoms that are not responding to the current best antibiotic therapies.
Individuals with persistent infection are likely to respond best to additional antibiotic therapy. Individuals with post- infectious causes require other approaches - such as ones that impact ongoing inflammation or altered neural circuits and metabolism. Safe and effective treatment for these individuals with persistent symptoms represents a prominent unmet need.
Vagus nerve stimulation (VNS) may be a treatment with considerable impact for patients with post-treatment Lyme disease. The vagus nerve (the 10th and longest cranial nerve) impacts the central nervous system, the autonomic nervous system (e.g, heart, lungs, digestive tract), and the systemic inflammatory response. It has also been shown to play a role in cognition, pain, mood disorders, inflammation, and immune function. Research over the last 2 decades has demonstrated that electrical stimulation of the vagus nerve can have multiple salutary effects in both animal models of disease and human illness. Until very recently, VNS has been considered an invasive intervention, reserved for patients with refractory disease, as it requires surgery to implant the device; this approach is costly and puts patients at risk of infection and other complications. These factors have limited the accessibility and broad application of VNS. A non-invasive approach to VNS would increase affordability, accessibility, and decrease risk. This is now possible. The first non-invasive external VNS device was cleared by the FDA for the treatment of cluster headaches and migraines in 2017.
Individuals with persistent infection are likely to respond best to additional antibiotic therapy. Individuals with post- infectious causes require other approaches - such as ones that impact ongoing inflammation or altered neural circuits and metabolism. Safe and effective treatment for these individuals with persistent symptoms represents a prominent unmet need.
Vagus nerve stimulation (VNS) may be a treatment with considerable impact for patients with post-treatment Lyme disease. The vagus nerve (the 10th and longest cranial nerve) impacts the central nervous system, the autonomic nervous system (e.g, heart, lungs, digestive tract), and the systemic inflammatory response. It has also been shown to play a role in cognition, pain, mood disorders, inflammation, and immune function. Research over the last 2 decades has demonstrated that electrical stimulation of the vagus nerve can have multiple salutary effects in both animal models of disease and human illness. Until very recently, VNS has been considered an invasive intervention, reserved for patients with refractory disease, as it requires surgery to implant the device; this approach is costly and puts patients at risk of infection and other complications. These factors have limited the accessibility and broad application of VNS. A non-invasive approach to VNS would increase affordability, accessibility, and decrease risk. This is now possible. The first non-invasive external VNS device was cleared by the FDA for the treatment of cluster headaches and migraines in 2017.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: