Fatigue, Headache, Post COVID Syndrome
Conditions
Brief summary
The purpose of this study is to evaluate the impact of vagal nerve stimulation on patients with post COVID syndrome who have fatigue and headache.
Detailed description
Patients, after consenting, will perform questionnaires, have a blood samples taken, and undergo PET/CT scans of the brain. Patients will then be randomized to either receive vagal nerve stimulation, or continue standard clinical care. For those randomized to receive treatment, they will be given a device and asked to follow a specific regimen daily for 12 weeks.
Interventions
DEVICEvagal nerve stimulator
Non-invasive vagus nerve stimulator
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of fatigue and post exertional malaise. * Presence of headache * Clinical diagnosis of post COVID syndrome. * They have consented to participate in the study * They have the ability to participate in all aspects of the study.
Exclusion criteria
* Pregnant. * Prior adverse reaction to 14FDG. * Active implantable medical device e.g. pacemaker, hearing aid implant * Metallic device e.g. stent, orthopedic hardware in neck * Using another electronic device at the same time e.g. TENS, mobile phone. * Any other condition deemed exclusionary by the study principal investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post-COVID Functional Status Score | Baseline to 12 weeks | Measurement is the change in scoring determined through patients' self-reported Post-COVID Functional Status Score survey, which assesses COVID-19 symptom impact on a grading scale of 0 = no limitations to 4 = severe limitations. Thus, higher scores are a worse outcome, and a change indicating an increase is a worsening of functional status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PROMIS Fatigue Scale T Score | Baseline to 12 weeks | Measurement is the change in score determined through patients' self-reported PROMIS Short Form v1.0 - Fatigue 7a. The PROMIS Fatigue Scale assesses 7 items on a scale of 1 (never) to 5 (always). Scale scores were converted to T scores using the published guidelines. A T-score of 50 is the average for the general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS Fatigue T-score represents more of the concept being measured; thus, an increase in fatigue T score corresponds to more fatigue - which is a worse outcome. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRyan T. Hurt, MD
Mayo Clinic
Participant flow
Recruitment details
Between 12/19/2022 and 03/06/2024, a total of 18 Long Covid patients were found to be eligible to participate in this study through a Long Covid Clinic at a single medical center.
Pre-assignment details
There was no washout period for this study. After consent, participants were screened, baseline study data were collected and randomized to study groups.
Participants by arm
| Arm | Count |
|---|---|
| VNS Treatment Subjects with post COVID syndrome with fatigue and headache will have vagal nerve stimulator applied to the neck for 2 minute intervals with two sets administered three times daily
vagal nerve stimulator: Non-invasive vagus nerve stimulator | 8 |
| Non-VNS Treatment Subjects with post COVID syndrome with fatigue and headache will receive current standard of care | 10 |
| Total | 18 |
Baseline characteristics
| Characteristic | VNS Treatment | Non-VNS Treatment | Total |
|---|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 10.8 | 46.9 years STANDARD_DEVIATION 14.7 | 46.6 years STANDARD_DEVIATION 12.8 |
| Race/Ethnicity, Customized Hispanic/White | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized NonHispanic/White | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 10 |
| other Total, other adverse events | 2 / 8 | 0 / 10 |
| serious Total, serious adverse events | 0 / 8 | 0 / 10 |
Outcome results
Primary
Change in Post-COVID Functional Status Score
Measurement is the change in scoring determined through patients' self-reported Post-COVID Functional Status Score survey, which assesses COVID-19 symptom impact on a grading scale of 0 = no limitations to 4 = severe limitations. Thus, higher scores are a worse outcome, and a change indicating an increase is a worsening of functional status.
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VNS Treatment | Change in Post-COVID Functional Status Score | 0.1 units on a scale | Standard Deviation 1 |
| Non-VNS Treatment | Change in Post-COVID Functional Status Score | 0.3 units on a scale | Standard Deviation 0.7 |
p-value: 0.544Wilcoxon (Mann-Whitney)
Secondary
Change in PROMIS Fatigue Scale T Score
Measurement is the change in score determined through patients' self-reported PROMIS Short Form v1.0 - Fatigue 7a. The PROMIS Fatigue Scale assesses 7 items on a scale of 1 (never) to 5 (always). Scale scores were converted to T scores using the published guidelines. A T-score of 50 is the average for the general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS Fatigue T-score represents more of the concept being measured; thus, an increase in fatigue T score corresponds to more fatigue - which is a worse outcome.
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VNS Treatment | Change in PROMIS Fatigue Scale T Score | -5.4 units on a scale | Standard Deviation 11.6 |
| Non-VNS Treatment | Change in PROMIS Fatigue Scale T Score | -1.9 units on a scale | Standard Deviation 4.7 |
p-value: 0.292ANCOVA