Multimodal Investigation of Post COVID-19 in Females
Study Details
Study Description
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".
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)
Electrode clip will be placed on the left ear.
|
Outcome Measures
Primary Outcome Measures
- Change in Flanker Inhibitory Control and Attention Test (Flanker) scores [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.
- Change in Picture Sequence Memory Test (PSMT) scores [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.
- Change in Dimensional Change Card Sort Test (DCCS) scores [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.
- Change in Pattern Comparison Processing Speed scores [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.
- Change in List Sorting Working Memory scores [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 Outcome Measures
- Change in Magnetic Resonance Imaging (MRI) [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.
- Change in resting state Electroencephalograph (EEG) signals [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.
- Change in blood marker levels [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.
- Change in BURNS Anxiety Inventory scores [At baseline, at week 3, and at week 7]
The BURNS Anxiety Inventory is a self-reported rating scale that measures anxiety symptoms.
- Change in Becks Depression Inventory (BDI) scores [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.
- Change in PROMIS Sleep Disturbance scores [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.
- Change in Fatigue Severity Scale scores [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.
- Change in Sniffin' Sticks olfactory performance [At baseline, at week 3, and at week 7]
The Sniffin' Sticks test (Burghardt®, Wedel, Germany) assesses odor threshold, odor discrimination, and odor identification.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Biologically female at birth and at time of enrollment
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At least 18 years of age or older
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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:
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Not t-VNS compatible (e.g. pacemaker implants)
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Not MRI compatible (e.g. metal implants, claustrophobia)
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Currently pregnant
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Long COVID without cognitive impairment
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History of neurological conditions prior to COVID-19 infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Casa Colina Hospital and Centers for Healthcare | Pomona | California | United States | 91769 |
Sponsors and Collaborators
- Casa Colina Hospital and Centers for Healthcare
Investigators
- Principal Investigator: Amy Zheng, PhD, Casa Colina Hospital and Centers for Healthcare
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB#00002372