NCT05225220

Multimodal Investigation of Post COVID-19 in Females

Completed NA Last updated 7 July 2023

What this trial tests

NA trial testing Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS) in Post COVID-19 in 25 participants. Completed in 6 January 2023.

Timeline

1 March 2022

Primary endpoint
6 January 2023

6 January 2023

Quick facts

Lead sponsor	Casa Colina Hospital and Centers for Healthcare
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	1 March 2022
Primary completion	6 January 2023
Estimated completion	6 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)

Conditions studied

• Post COVID-19 — all drugs for Post COVID-19 →
• Cognitive Dysfunction — all drugs for Cognitive Dysfunction →

Sponsor

Casa Colina Hospital and Centers for Healthcare

Who can join

Adults 18 to 85, female only, with Post COVID-19 or Cognitive Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to investigate the effects of transcutaneous vagus nerve stimulation (t-VNS) on Long Covid symptoms in females and to identify factors influencing susceptibility and recovery-particularly in the cognitive domain, as over 80% of long-haulers experience "brain fog".

Publications & conference data

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

1. Interventions for mental health, cognition, and psychological wellbeing in long COVID: a systematic review of registered trials.
   Hawke LD, Nguyen ATP, Ski CF, Thompson DR, et al · · 2022 · cited 45× · PMID 35768406 · DOI 10.1017/s0033291722002203
2. Detrimental effects of COVID-19 in the brain and therapeutic options for long COVID: The role of Epstein-Barr virus and the gut-brain axis.
   Hashimoto K. · · 2023 · cited 34× · PMID 37402856 · DOI 10.1038/s41380-023-02161-5
3. Transcutaneous vagus nerve stimulation improves Long COVID symptoms in a female cohort: a pilot study.
   Zheng ZS, Simonian N, Wang J, Rosario ER. · · 2024 · cited 16× · PMID 38756213 · DOI 10.3389/fneur.2024.1393371
4. Neuromodulation Strategies to Reduce Inflammation and Improve Lung Complications in COVID-19 Patients.
   Czura CJ, Bikson M, Charvet L, Chen JDZ, et al · · 2022 · cited 13× · PMID 35911909 · DOI 10.3389/fneur.2022.897124
5. The diversity of neuroimmune circuits controlling lung inflammation.
   Cremin M, Schreiber S, Murray K, Tay EXY, et al · · 2023 · cited 11× · PMID 36410021 · DOI 10.1152/ajplung.00179.2022
6. The effects of long COVID-19, its severity, and the need for immediate attention: Analysis of clinical trials and Twitter data.
   Bhattacharyya A, Seth A, Rai S. · · 2022 · cited 4× · PMID 36588926 · DOI 10.3389/fdata.2022.1051386
7. The Effects of Long COVID-19, its Severity, and the Need for Immediate Attention: Analysis of Clinical Trials and Twitter data
   Bhattacharyya A, Seth A, Rai S. · · 2022 · DOI 10.1101/2022.09.13.22279833