Post COVID-19NCT05225220
Multimodal Investigation of Post COVID-19 in Females
A study testing Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS) in people with Post COVID-19 and Cognitive Dysfunction, run by Casa Colina Hospital and Centers for Healthcare at 1 site in United States.
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". Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Post COVID-19, Cognitive Dysfunction
- What is being tested?
- Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 6 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Casa Colina Hospital and Centers for Healthcare
Pomona, California, 91769
About this study
Official title: Multimodal Investigation of Post COVID-19 in Females: A Pilot Study
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".
Read the 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).
- Conditions
- Post COVID-19, Cognitive Dysfunction
- Being tested
- Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)
- 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
- Medical subject headings
- Cognitive Dysfunction, Post-Acute COVID-19 Syndrome, Mental Fatigue, Anosmia, Neurologic Manifestations, Inflammation, Fatigue, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)Device
Electrode clip will be placed on the left ear.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, at week 3, and at week 7
Secondary outcomes (8)
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.
Measured: At baseline and at week 3
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.
Measured: At baseline and at week 3
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.
Measured: At baseline and at week 3
Change in BURNS Anxiety Inventory scores
The BURNS Anxiety Inventory is a self-reported rating scale that measures anxiety symptoms.
Measured: At baseline, at week 3, and at week 7
Change in Becks Depression Inventory (BDI) scores
The BDI is a self-reported rating inventory that measures characteristic attitudes and symptoms of depression.
Measured: At baseline, at week 3, and at week 7
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.
Measured: At baseline, at week 3, and at week 7
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.
Measured: At baseline, at week 3, and at week 7
Change in Sniffin' Sticks olfactory performance
The Sniffin' Sticks test (Burghardt®, Wedel, Germany) assesses odor threshold, odor discrimination, and odor identification.
Measured: At baseline, at week 3, and at week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Mar 2022
- Primary completion6 Jan 2023
- Study completion6 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Casa Colina Hospital and Centers for Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Zheng, Casa Colina Hospital and Centers for Healthcare
- Investigators
- Amy Zheng, PhD, Principal investigator, Casa Colina Hospital and Centers for Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225220
- Sponsor's protocol ID
- IRB#00002372
- Status last verified
- Jul 2023
- First submitted
- 2 Feb 2022
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Investigation of Post COVID-19 in Females: A Pilot Study
- ClinicalTrials.gov ID
- NCT05225220
- Acronym / sponsor ID
- IRB#00002372
- Conditions
- Post COVID-19, Cognitive Dysfunction
- Keywords
- Long COVID, Post COVID-19 Syndrome, COVID long-haulers, Brain fog, Anosmia/Hyposmia, Neurological symptoms, EEG, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Casa Colina Hospital and Centers for HealthcareUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Vagus Nerve Stimulation (t-VNS) | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)Electrode clip will be placed on the left ear. | Device | Transcutaneous Vagus Nerve Stimulation (t-VNS) |
Primary outcome
Change in Flanker Inhibitory Control and Attention Test (Flanker) scores
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
8 secondary outcomes
Change in Magnetic Resonance Imaging (MRI)
Time frame: At baseline and at week 3
Change in resting state Electroencephalograph (EEG) signals
Time frame: At baseline and at week 3
Change in blood marker levels
Time frame: At baseline and at week 3
Change in BURNS Anxiety Inventory scores
Time frame: At baseline, at week 3, and at week 7
Change in Becks Depression Inventory (BDI) scores
Time frame: At baseline, at week 3, and at week 7
Change in PROMIS Sleep Disturbance scores
Time frame: At baseline, at week 3, and at week 7
Change in Fatigue Severity Scale scores
Time frame: At baseline, at week 3, and at week 7
Change in Sniffin' Sticks olfactory performance
Time frame: At baseline, at week 3, and at week 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
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The Study of Brave-LC LDN Treatment Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Zheng, PhD principal investigator
Casa Colina Hospital and Centers for Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS) in people with Post COVID-19 and Cognitive Dysfunction, run by Casa Colina Hospital and Centers for Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Flanker Inhibitory Control and Attention Test (Flanker) scores (time frame: At baseline, at week 3, and at week 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.