Cognitive Dysfunction, Post COVID-19
Conditions
Keywords
Long COVID, Post COVID-19 Syndrome, COVID long-haulers, Brain fog, Anosmia/Hyposmia, Neurological symptoms, EEG, MRI, Genetics, Inflammation, Transcutaneous vagus nerve stimulation, Fatigue, Anxiety, Depression, Cognitive impairment
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).
Interventions
DEVICEParasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)
Electrode clip will be placed on the left ear.
Sponsors
Casa Colina Hospital and Centers for Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 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. |
Countries
United States
Outcome results
None listed