Skip to main content
OpenTrials
Completed

NCT Number: NCT05225220

Multimodal Investigation of Post COVID-19 in Females

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".

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Covid-19 Anosmia Anxiety Disorders Behavior Behavioral Symptoms COVID-19 Chronic Disease Cognition Disorders Cognitive Dysfunction Coronaviridae Infections Coronavirus Infections Depression Disease Attributes Fatigue Infections Inflammation Lung Diseases Mental Disorders Mental Fatigue Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Nidovirales Infections Olfaction Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sensation Disorders Signs and Symptoms Virus Diseases

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Casa Colina Hospital and Centers for Healthcare

Pomona, California, 91769, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Electrode clip will be placed on the left ear.

Primary outcomes

  1. Change in Flanker Inhibitory Control and Attention Test (Flanker) scores

    Time frame: At baseline, at week 3, and at week 7

    Flanker is a non-verbal NIH Toolbox Cognition Battery assessment that measures both a participant's attention and inhibitory control.

  2. Change in Picture Sequence Memory Test (PSMT) scores

    Time frame: At baseline, at week 3, and at week 7

    PSMT is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's episodic memory.

  3. Change in Dimensional Change Card Sort Test (DCCS) scores

    Time frame: At baseline, at week 3, and at week 7

    DCCS is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's executive functioning.

  4. Change in Pattern Comparison Processing Speed scores

    Time frame: At baseline, at week 3, and at week 7

    Pattern Comparison Processing Speed is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's processing speed.

  5. Change in List Sorting Working Memory scores

    Time frame: At baseline, at week 3, and at week 7

    List Sorting Working Memory is an oral NIH Toolbox Cognition Battery assessment that measures a participant's working memory.

Secondary outcomes

  1. Change in Magnetic Resonance Imaging (MRI)

    Time frame: At baseline and at week 3

    MRI scans will be acquired on a Siemens Magnetom Verio 3T Scanner at Casa Colina Imaging Center to assess structural changes.

  2. Change in resting state Electroencephalograph (EEG) signals

    Time frame: At baseline and at week 3

    Using a 64-channel EEG system, we will perform resting-state EEG recordings to assess power spectral density changes.

  3. Change in blood marker levels

    Time frame: At baseline and at week 3

    Blood markers related to COVID-19, inflammation, brain injury, and neuroplasticity will be analyzed using the Ella automated immunoassay system.

  4. Change in BURNS Anxiety Inventory scores

    Time frame: At baseline, at week 3, and at week 7

    The BURNS Anxiety Inventory is a self-reported rating scale that measures anxiety symptoms.

  5. Change in Becks Depression Inventory (BDI) scores

    Time frame: At baseline, at week 3, and at week 7

    The BDI is a self-reported rating inventory that measures characteristic attitudes and symptoms of depression.

  6. Change in PROMIS Sleep Disturbance scores

    Time frame: At baseline, at week 3, and at week 7

    The PROMIS Sleep Disturbance (8b) is a self-reported measure for perception of sleep quality, depth of sleep, satisfaction with sleep, and perception of difficulty getting and staying asleep.

  7. Change in Fatigue Severity Scale scores

    Time frame: At baseline, at week 3, and at week 7

    The Fatigue Severity Scale is a self-reported 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders.

  8. Change in Sniffin' Sticks olfactory performance

    Time frame: At baseline, at week 3, and at week 7

    The Sniffin' Sticks test (Burghardt®, Wedel, Germany) assesses odor threshold, odor discrimination, and odor identification.

Sponsors and collaborators

Lead sponsor

Casa Colina Hospital and Centers for Healthcare

Other

Registry information

Official study title

Multimodal Investigation of Post COVID-19 in Females: A Pilot Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 4, 2022
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.