Trial Outcomes & Findings for Vagus Nerve Stimulation as Treatment for Long Covid (NCT NCT05608629)

Last Updated: 2024-01-08

Results Overview

Treatment success is defined as patient had to improve on 2 of the following: a 14% improvement in SF-36 -- physical function (0-100 scale, higher score = less disability; report of marked or moderate improvement (2-3 on a scale going from +3 to -3\] based on the treatment \[patient global indication of change (0-7, higher score = more improvement); going from fatigue case to no fatigue on Chalder fatigue scale (0-3, higher score = more fatigue; improvement on VAS of at least 2 points \[VAS going from none \[0\] to 5 \[very severe\] with at least a 3 \[substantial\] on one of the following Sx --\> fatigue, brain fog, widespread pain

Recruitment status

COMPLETED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

Baseline to post-treatment at 6-weeks

Results posted on

2024-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Transcutaneous Non-Invasive Vagus Nerve Stimulation Application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day Transcutaneous Non-Invasive Vagus Nerve Stimulation: The parasym is a system for delivering a fixed signal to stimulate the auricular branch of the vagus nerve. The device used is available without prescription in UK and EU. Similar devices have been used to treat migraine and one is in testing to be used for atrial fibrillation.
Overall Study STARTED	17
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Transcutaneous Non-Invasive Vagus Nerve Stimulation Application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day Transcutaneous Non-Invasive Vagus Nerve Stimulation: The parasym is a system for delivering a fixed signal to stimulate the auricular branch of the vagus nerve. The device used is available without prescription in UK and EU. Similar devices have been used to treat migraine and one is in testing to be used for atrial fibrillation.
Overall Study Lost to Follow-up	2

Baseline Characteristics

Vagus Nerve Stimulation as Treatment for Long Covid

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcutaneous Non-Invasive Vagus Nerve Stimulation n=17 Participants Application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day Transcutaneous Non-Invasive Vagus Nerve Stimulation: The parasym is a system for delivering a fixed signal to stimulate the auricular branch of the vagus nerve. The device used is available without prescription in UK and EU. Similar devices have been used to treat migraine and one is in testing to be used for atrial fibrillation.
Age, Continuous	43.7 years STANDARD_DEVIATION 8.19 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to post-treatment at 6-weeks

Outcome measures

Outcome measures
Measure	Transcutaneous Non-Invasive Vagus Nerve Stimulation n=15 Participants Application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day Transcutaneous Non-Invasive Vagus Nerve Stimulation: The parasym is a system for delivering a fixed signal to stimulate the auricular branch of the vagus nerve. The device used is available without prescription in UK and EU. Similar devices have been used to treat migraine and one is in testing to be used for atrial fibrillation.
Number of Participants With Treatment Success	8 Participants

SECONDARY outcome

Timeframe: 6 weeks

Number of participants with reductions of at least 10 points on the short version of the Profile of Mood States. The POMS ranges from 0 -120. Higher score indicates poorer health outcomes.

Outcome measures

Outcome measures
Measure	Transcutaneous Non-Invasive Vagus Nerve Stimulation n=15 Participants Application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day Transcutaneous Non-Invasive Vagus Nerve Stimulation: The parasym is a system for delivering a fixed signal to stimulate the auricular branch of the vagus nerve. The device used is available without prescription in UK and EU. Similar devices have been used to treat migraine and one is in testing to be used for atrial fibrillation.
Number of Participants With Change in the Profile of Mood States (POMS)	5 Participants

Adverse Events

Transcutaneous Non-Invasive Vagus Nerve Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Benjamin H Natelson

Icahn School of Medicine at Mount Sinai

Phone: (212) 844-6665

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place