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".
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Electrode clip will be placed on the left ear.
Casa Colina Hospital and Centers for Healthcare
Pomona, California, United States
Change in Flanker Inhibitory Control and Attention Test (Flanker) scores
Flanker is a non-verbal NIH Toolbox Cognition Battery assessment that measures both a participant's attention and inhibitory control.
Time frame: At baseline, at week 3, and at week 7
Change in Picture Sequence Memory Test (PSMT) scores
PSMT is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's episodic memory.
Time frame: At baseline, at week 3, and at week 7
Change in Dimensional Change Card Sort Test (DCCS) scores
DCCS is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's executive functioning.
Time frame: At baseline, at week 3, and at week 7
Change in Pattern Comparison Processing Speed scores
Pattern Comparison Processing Speed is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's processing speed.
Time frame: At baseline, at week 3, and at week 7
Change in List Sorting Working Memory scores
List Sorting Working Memory is an oral NIH Toolbox Cognition Battery assessment that measures a participant's working memory.
Time frame: At baseline, at week 3, and at week 7
Change in Magnetic Resonance Imaging (MRI)
MRI scans will be acquired on a Siemens Magnetom Verio 3T Scanner at Casa Colina Imaging Center to assess structural changes.
Time frame: At baseline and at week 3
Change in resting state Electroencephalograph (EEG) signals
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Using a 64-channel EEG system, we will perform resting-state EEG recordings to assess power spectral density changes.
Time frame: At baseline and at week 3
Change in blood marker levels
Blood markers related to COVID-19, inflammation, brain injury, and neuroplasticity will be analyzed using the Ella automated immunoassay system.
Time frame: At baseline and at week 3
Change in BURNS Anxiety Inventory scores
The BURNS Anxiety Inventory is a self-reported rating scale that measures anxiety symptoms.
Time frame: At baseline, at week 3, and at week 7
Change in Becks Depression Inventory (BDI) scores
The BDI is a self-reported rating inventory that measures characteristic attitudes and symptoms of depression.
Time frame: At baseline, at week 3, and at week 7
Change in PROMIS Sleep Disturbance scores
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.
Time frame: At baseline, at week 3, and at week 7
Change in Fatigue Severity Scale scores
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.
Time frame: At baseline, at week 3, and at week 7
Change in Sniffin' Sticks olfactory performance
The Sniffin' Sticks test (Burghardt®, Wedel, Germany) assesses odor threshold, odor discrimination, and odor identification.
Time frame: At baseline, at week 3, and at week 7