Trials / Completed
CompletedNCT05608629
Vagus Nerve Stimulation as Treatment for Long Covid
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Icahn School of Medicine at Mount Sinai · Academic / Other
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2022-06-06
- Primary completion
- 2022-12-05
- Completion
- 2022-12-05
- First posted
- 2022-11-08
- Last updated
- 2024-01-08
- Results posted
- 2024-01-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05608629. Inclusion in this directory is not an endorsement.