NCT05225220

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

February 2, 2022

Last Update Submit

July 5, 2023

Conditions

Post COVID-19Cognitive Dysfunction

Keywords

Long COVIDPost COVID-19 SyndromeCOVID long-haulersBrain fogAnosmia/HyposmiaNeurological symptomsEEGMRIGeneticsInflammationTranscutaneous vagus nerve stimulationFatigueAnxietyDepressionCognitive impairment

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (8)

  • Change in Magnetic Resonance Imaging (MRI)

    At baseline and at week 3

  • Change in resting state Electroencephalograph (EEG) signals

    At baseline and at week 3

  • Change in blood marker levels

    At baseline and at week 3

  • Change in BURNS Anxiety Inventory scores

    At baseline, at week 3, and at week 7

  • Change in Becks Depression Inventory (BDI) scores

    At baseline, at week 3, and at week 7

  • +3 more secondary outcomes

Study Arms (1)

Transcutaneous Vagus Nerve Stimulation (t-VNS)

EXPERIMENTAL

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)

Interventions

Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)DEVICE

Electrode clip will be placed on the left ear.

Transcutaneous Vagus Nerve Stimulation (t-VNS)

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must be of female sex at birth and at time of study enrollment.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Casa Colina Hospital and Centers for Healthcare

Pomona, California, 91769, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionPost-Acute COVID-19 SyndromeMental FatigueAnosmiaNeurologic ManifestationsInflammationFatigueAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersCOVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsBehavioral SymptomsBehaviorOlfaction DisordersSensation DisordersNervous System Diseases

Study Officials

  • Amy Zheng, PhD

    Casa Colina Hospital and Centers for Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 4, 2022

Study Start

March 1, 2022

Primary Completion

January 6, 2023

Study Completion

January 6, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Locations

US(1)