tVNS in Long COVID-19

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06585254
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous vagus nerve stimulator — DEVICE
    A device attached to the tragus of the ear which when activated stimulates an ascending branch of the vagus nerve

Study Details

A prior open label study has shown that transcutaneous vagus nerve stimulation \[tVNS\] can improve the health of some patients with postacute sequelae of SARS-CoV-2 infection (PASC), severely affected enough to also fulfill criteria for myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS). The purpose of this study is to compare two sets of stimulus parameters to determine the one that best improves the health-related quality of life of these patients over a period of 6-weeks. Patients using their assigned device for at least 30 of the 42 possible opportunities will receive the best device for an additional 6-week period.

Key Dates

Start date
Nov 1, 2024
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: #1: Patient controlled
    Patient will ramp up current intensity until uncomfortable, then ratchet back to what is comfortable and press button. Patient is to do this daily for 35 minutes for 6 weeks.
  • Experimental: #2: Device Controlled
    Patients will ramp up current intensity until uncomfortable, then ratchet back to what is comfortable and press button. The device has software embedded in it that is used to arrive at a personalized way of stimulating the vagus nerve. At this level, the device stimulus will not be sensed by the patient. Patient is to do this daily for 35 minutes for 6 weeks.

Primary Outcome Measure

The Chalder Fatigue Questionnaire (CFQ) [ Time Frame: Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Benjamin H Natelson, MD
[email protected]
212-844-6665
Anna Norweg, PhD
[email protected]
212-844-6665

Find similar trials in New York, NY

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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