NCT04774705: SNV-Sepsis

Effectiveness of Non-invasive Vagus Nerve Stimulation as an Adjuvant Treatment in Patients With Sepsis in Intensive Care.

Recruiting now NA Last updated 17 July 2024

What this trial tests

NA trial testing SNV activ group (Non-invasive transcutaneous stimulation of the vagus nerve ) in Sepsis in 30 participants. Currently enrolling.

Timeline

29 March 2021

Primary endpoint
29 March 2025

29 March 2025

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	30
Start date	29 March 2021
Primary completion	29 March 2025
Estimated completion	29 March 2025
Sites	1 location across France

Drugs / interventions tested

• SNV activ group (Non-invasive transcutaneous stimulation of the vagus nerve )
• Placebo group

Conditions studied

• Sepsis — all drugs for Sepsis →
• Septic Shock — all drugs for Septic Shock →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Sepsis or Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sepsis is one of the leading causes of death in intensive care. About 50% of patients with septic shock die after 1 year; and 50% of survivors suffer from cognitive decline. The pathophysiological mechanisms of serious complications of sepsis are now well known. In fact, the systemic inflammation related to sepsis amplifies the release of pro-inflammatory cytokines and neurotoxic mediators, hence an increase in deleterious phenomena such as oxidative stress, mitochondrial dysfunction, endothelial activation, disruption of the blood-brain barrier, neuroinflammation (astrocytic and microglial activation) leading to multi-organ failure which compromises the patient's vital and functional prognosis. Although there has been progress in the understanding of its pathophysiology, the management of sepsis and septic shock in intensive care relies mainly on anti-infective treatments and the restoration of cardiovascular and respiratory functions. There is virtually no adjuvant therapy for the management of sepsis, apart from a few hormonal therapies such as insulin to maintain blood glucose levels below 180 mg / dL and low doses of corticosteroids and vasopressin. There is therefore a pressing need to develop innovative treatments targeting inflammatory and immunological processes in order to reduce the complications of sepsis and improve patient prognosis. Some recent work has shown that electrical vagus nerve stimulation (SNV), a technique used for the treatment of drug-resistant epilepsy, can modulate inflammatory and immune responses and control inflammation syndrome in animal models of sepsis, arthritis and rheumatism in humans. In this pilot study the investigators plan to evaluate the efficacy of transcutaneous (non-invasive) SNV as an adjuvant treatment in patients with sepsis in intensive care.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Chronic granulomatous disease with suspected secondary hemophagocytic lymphohistiocytosis: a case report and hypothesis-generating rationale for neuroimmune modulation.
   Goggins E, Afzali B, Okusa MD. · · 2026 · PMID 41840644 · DOI 10.1186/s13054-026-05945-7
2. Vagus Nerve Regulation of Inflammatory Responses in Sepsis: Mechanistic Insights and Translational Applications.
   Chen G, Yan Y, Liu S, He Y, et al · · 2026 · PMID 41737248 · DOI 10.2147/jir.s583388