Multimodal Investigation of Post COVID-19 in Females

Cognitive Dysfunction Clinical Trial

Official title:

Multimodal Investigation of Post COVID-19 in Females: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05225220
• Other study ID #: IRB#00002372
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: January 6, 2023

Study information

• Verified date: July 2023
• Source: Casa Colina Hospital and Centers for Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 6, 2023
• Est. primary completion date: January 6, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• COVID-19
• Post COVID-19

Intervention

Device:
• Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)
Electrode clip will be placed on the left ear.

Locations

Country	Name	City	State
United States	Casa Colina Hospital and Centers for Healthcare	Pomona	California

Sponsors (1)

Lead Sponsor	Collaborator
Casa Colina Hospital and Centers for Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Change in resting state Electroencephalograph (EEG) signals	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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