Multimodal Investigation of Post COVID-19 in Females

NCT ID: NCT05225220

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-01-06

Brief Summary

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".

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).

Conditions

Post COVID-19; Cognitive Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Electrode clip will be placed on the left ear.

Interventions

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

Electrode clip will be placed on the left ear.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Casa Colina Hospital and Centers for Healthcare

OTHER

Sponsor Role: lead

Responsible Party

Amy Zheng

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Zheng, PhD

Role: PRINCIPAL_INVESTIGATOR

Casa Colina Hospital and Centers for Healthcare

Locations

Casa Colina Hospital and Centers for Healthcare

Pomona, California, United States

Countries

United States

Other Identifiers

IRB#00002372

Identifier Type: -

Identifier Source: org_study_id