Multimodal Investigation of Post COVID-19 in Females

Purpose

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".

Conditions

  • Post COVID-19
  • Cognitive Dysfunction

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Biologically female at birth and at time of enrollment - At least 18 years of age or older - Experiencing persistent symptoms of brain fog/cognitive impairment beyond 3 months of COVID-19 infection that are not explained by an alternative diagnosis

Exclusion Criteria

  • Not t-VNS compatible (e.g. pacemaker implants) - Not MRI compatible (e.g. metal implants, claustrophobia) - Currently pregnant - Long COVID without cognitive impairment - History of neurological conditions prior to COVID-19 infection

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Transcutaneous Vagus Nerve Stimulation (t-VNS) 		Participants will receive 60 minutes of t-VNS stimulation every day for 10 consecutive days while wearing a fitness tracker.
  • Device: Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)
    Electrode clip will be placed on the left ear.

Recruiting Locations

More Details

NCT ID
NCT05225220
Status
Completed
Sponsor
Casa Colina Hospital and Centers for Healthcare

Detailed Description

Long COVID is a post-viral illness estimated to affect 10-30% of COVID-19 patients. Post-COVID symptoms can last for months and affect multiple organs. Major risk factors of long COVID include the female sex and pre-existing anxiety/depression. Because women already have higher rates of anxiety/depression, the combined risks could exacerbate their susceptibility. Based on the rationale that long COVID symptoms significantly overlap with functions of the vagus nerve, which serves as a conduit between the brain and body, the investigators propose to use non-invasive transcutaneous vagus nerve stimulation (t-VNS) as a novel treatment for long COVID in 20 female participants. This pilot study will utilize a holistic approach by integrating neuromodulation, neuroimaging, genetics, blood biomarkers, behavioral assessments, and wearable technology to examine the effects of VNS therapy on post COVID-19 symptoms and to identify factors that influence susceptibility and recovery, particularly in the cognitive domain, as over 80% of long-haulers report experiencing "brain fog" (i.e., cognitive disruptions).