Trial Outcomes & Findings for Vagal Nerve Stimulation for Post COVID Fatigue (NCT NCT05445427)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

Baseline to 12 weeks

Results posted on

2025-03-12

Participant Flow

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.

There was no washout period for this study. After consent, participants were screened, baseline study data were collected and randomized to study groups.

Participant milestones

Participant milestones
Measure	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	Non-VNS Treatment Subjects with post COVID syndrome with fatigue and headache will receive current standard of care
Overall Study STARTED	8	10
Overall Study COMPLETED	8	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vagal Nerve Stimulation for Post COVID Fatigue

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VNS Treatment n=8 Participants 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	Non-VNS Treatment n=10 Participants Subjects with post COVID syndrome with fatigue and headache will receive current standard of care	Total n=18 Participants Total of all reporting groups
Age, Continuous	46.3 years STANDARD_DEVIATION 10.8 • n=5 Participants	46.9 years STANDARD_DEVIATION 14.7 • n=7 Participants	46.6 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized NonHispanic/White	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	VNS Treatment n=8 Participants 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	Non-VNS Treatment n=10 Participants Subjects with post COVID syndrome with fatigue and headache will receive current standard of care
Change in Post-COVID Functional Status Score	0.1 units on a scale Standard Deviation 1.0	0.3 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	VNS Treatment n=8 Participants 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	Non-VNS Treatment n=10 Participants Subjects with post COVID syndrome with fatigue and headache will receive current standard of care
Change in PROMIS Fatigue Scale T Score	-5.4 units on a scale Standard Deviation 11.6	-1.9 units on a scale Standard Deviation 4.7

Adverse Events

VNS Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Non-VNS Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	VNS Treatment n=8 participants at risk 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	Non-VNS Treatment n=10 participants at risk Subjects with post COVID syndrome with fatigue and headache will receive current standard of care
Gastrointestinal disorders Nausea	12.5% 1/8 • Number of events 1 • During the 12 weeks of the study treatment period	0.00% 0/10 • During the 12 weeks of the study treatment period
Musculoskeletal and connective tissue disorders Neck Tightness	12.5% 1/8 • Number of events 1 • During the 12 weeks of the study treatment period	0.00% 0/10 • During the 12 weeks of the study treatment period

Additional Information

Dr. Ryan T. Hurt, MD, PhD

Mayo Clinic

Phone: 507-284-4461

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place