Clinical trial NCT05225220: Multimodal Investigation of Post COVID-19 in Females
Official title: Multimodal Investigation of Post COVID-19 in Females: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post COVID-19
Cognitive Dysfunction
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
Lead sponsor: Casa Colina Hospital and Centers for Healthcare
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Flanker Inhibitory Control and Attention Test (Flanker) scores
timeFrame: At baseline, at week 3, and at week 7
measure: Change in Picture Sequence Memory Test (PSMT) scores
timeFrame: At baseline, at week 3, and at week 7
measure: Change in Dimensional Change Card Sort Test (DCCS) scores
timeFrame: At baseline, at week 3, and at week 7
measure: Change in Pattern Comparison Processing Speed scores
timeFrame: At baseline, at week 3, and at week 7
measure: Change in List Sorting Working Memory scores
timeFrame: At baseline, at week 3, and at week 7
Secondary outcomes:
measure: Change in Magnetic Resonance Imaging (MRI)
timeFrame: At baseline and at week 3
measure: Change in resting state Electroencephalograph (EEG) signals
timeFrame: At baseline and at week 3
measure: Change in blood marker levels
timeFrame: At baseline and at week 3
measure: Change in BURNS Anxiety Inventory scores
timeFrame: At baseline, at week 3, and at week 7
measure: Change in Becks Depression Inventory (BDI) scores
timeFrame: At baseline, at week 3, and at week 7
measure: Change in PROMIS Sleep Disturbance scores
timeFrame: At baseline, at week 3, and at week 7
measure: Change in Fatigue Severity Scale scores
timeFrame: At baseline, at week 3, and at week 7
measure: Change in Sniffin' Sticks olfactory performance
timeFrame: At baseline, at week 3, and at week 7
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Casa Colina Hospital and Centers for Healthcare
state: California
Study officials:
affiliation: Casa Colina Hospital and Centers for Healthcare
name: Amy Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: