Multimodal Investigation of Post COVID-19 in Females

Not Applicable

Completed

• Conditions: Cognitive Dysfunction; Post COVID-19
• Interventions: Device: Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)

• Registration Number: NCT05225220
• Lead Sponsor: Casa Colina Hospital and Centers for Healthcare

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).

Study Timeline

• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-04
• Study Start: 2022-03-01
• Primary Completion: 2023-01-06
• Study Completion: 2023-01-06
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-05
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 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 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

Name	Time	Method
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 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 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 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 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 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 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.

Trial Locations

Locations (1)

Casa Colina Hospital and Centers for Healthcare; 🇺🇸 Pomona, California, United States