Multimodal Investigation of Post COVID-19 in Females

Casa Colina Hospital and Centers for Healthcare

Status: Completed

Conditions: Cognitive Dysfunction; Post COVID-19

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05225220

IRB#00002372

Details and patient eligibility

About

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".

Full 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).

Enrollment: 25 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

Transcutaneous Vagus Nerve Stimulation (t-VNS)

Experimental group

Description:

Participants will receive 60 minutes of t-VNS stimulation every day for 10 consecutive days while wearing a fitness tracker.

Treatment:

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