Long COVIDNCT05608629
Vagus Nerve Stimulation as Treatment for Long Covid
A study testing Transcutaneous Non-Invasive Vagus Nerve Stimulation in people with Long COVID and Chronic Fatigue Syndrome, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Many patients do not recover following Covid infection. The resulting illness is called Long Covid. Because there is no agreed upon treatment for this ailment, the research team has decided to do an open label pilot study using non-invasive, transcutaneous stimulation of the auricular branch of the vagus nerve. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Long COVID, Chronic Fatigue Syndrome
- What is being tested?
- Transcutaneous Non-Invasive Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to 5 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients had to have had COVID
- Patients have to fulfill the 1994 case definition for chronic fatigue syndrome.
Who cannot join
- BMI > 30
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Many patients do not recover following Covid infection. The resulting illness is called Long Covid. Because there is no agreed upon treatment for this ailment, the research team has decided to do an open label pilot study using non-invasive, transcutaneous stimulation of the auricular branch of the vagus nerve. Inclusion criteria required the patient to fulfill criteria for having chronic fatigue syndrome. To date, fourteen patients provided evaluable data. Eight of these fulfilled the study's requirements for treatment success.
Read the detailed description
Patients who have had COVID and who fulfill criteria for chronic fatigue syndrome will sign IC and be mailed a parasym device with instructions its use after completing entry baseline questionnaires. Subjects will be called two, four and six weeks after beginning participation [application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day] to ask about adverse events. At the end of 6 weeks, patients will complete these questionnaires again plus one assessing their assessment of treatment efficacy.
- Conditions
- Long COVID, Chronic Fatigue Syndrome
- Being tested
- Transcutaneous Non-Invasive Vagus Nerve Stimulation
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Non-Invasive Vagus Nerve StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Non-Invasive Vagus Nerve Stimulation | Experimental | Application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day Receives: Device: Transcutaneous Non-Invasive Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Success
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
Measured: Baseline to post-treatment at 6-weeks
Secondary outcomes (1)
Number of Participants With Change in the Profile of Mood States (POMS)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start6 Jun 2022
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Model description
- Application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day for 6 weeks
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Natelson, Icahn School of Medicine at Mount Sinai
- Investigators
- Benjamin Natelson, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608629
- Sponsor's protocol ID
- STUDY-21-01846
- Status last verified
- Mar 2023
- First submitted
- 4 Nov 2022
- Last updated
- 8 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagus Nerve Stimulation as Treatment for Long Covid
- ClinicalTrials.gov ID
- NCT05608629
- Acronym / sponsor ID
- STUDY-21-01846
- Conditions
- Long COVID, Chronic Fatigue Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 8 Nov 2022 (actual)
- Results
- Posted 8 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many patients do not recover following Covid infection. The resulting illness is called Long Covid. Because there is no agreed upon treatment for this ailment, the research team has decided to do an open label pilot study using non-invasive, transcutaneous stimulation of the auricular branch of the vagus nerve. Inclusion criteria required the patient to fulfill criteria for having chronic fatigue syndrome. To date, fourteen patients provided evaluable data. Eight of these fulfilled the study's requirements for treatment success.
Detailed description
Patients who have had COVID and who fulfill criteria for chronic fatigue syndrome will sign IC and be mailed a parasym device with instructions its use after completing entry baseline questionnaires. Subjects will be called two, four and six weeks after beginning participation [application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day] to ask about adverse events. At the end of 6 weeks, patients will complete these questionnaires again plus one assessing their assessment of treatment efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day for 6 weeks
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Non-Invasive Vagus Nerve Stimulation | Experimental | Device: Transcutaneous Non-Invasive Vagus Nerve StimulationApplication of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients had to have had COVID
- Patients have to fulfill the 1994 case definition for chronic fatigue syndrome.
Key exclusion criteria (1 listed)
- BMI > 30
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 |
|---|---|---|
| Transcutaneous Non-Invasive Vagus Nerve StimulationThe 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. | Device | Transcutaneous Non-Invasive Vagus Nerve Stimulation |
Primary outcome
Number of Participants With Treatment Success
Time frame: Baseline to post-treatment at 6-weeks
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
1 secondary outcome
Number of Participants With Change in the Profile of Mood States (POMS)
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
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.
Benjamin Natelson, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Non-Invasive Vagus Nerve Stimulation in people with Long COVID and Chronic Fatigue Syndrome, run by Icahn School of Medicine at Mount Sinai 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 2 inclusion and 1 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 8 Jan 2024. 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?
Yes. Results are posted in the registry (first posted 8 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment Success (time frame: Baseline to post-treatment at 6-weeks). 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 8 Jan 2024.