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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Vagus Nerve Stimulation (t-VNS) | Experimental | Participants will receive 60 minutes of t-VNS stimulation every day for 10 consecutive days while wearing a fitness tracker. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS) | Device | Electrode clip will be placed on the left ear. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | At baseline, at week 3, and at week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and at week 3 |
| Change in resting state Electroencephalograph (EEG) signals |
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Inclusion Criteria:
Exclusion Criteria:
Participants must be of female sex at birth and at time of study enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Amy Zheng, PhD | Casa Colina Hospital and Centers for Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casa Colina Hospital and Centers for Healthcare | Pomona | California | 91769 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000094024 | Post-Acute COVID-19 Syndrome |
| D005222 | Mental Fatigue |
| D000086582 | Anosmia |
| D009461 | Neurologic Manifestations |
| D007249 | Inflammation |
| D005221 | Fatigue |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000086382 | COVID-19 |
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Using a 64-channel EEG system, we will perform resting-state EEG recordings to assess power spectral density changes. |
| 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. | 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. | 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. | 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. | 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. | 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. | At baseline, at week 3, and at week 7 |
| D011024 |
| Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
| D009422 | Nervous System Diseases |