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Nerve Block for Long COVID (DSBLongCOVID Trial)

Phase 1

Waitlist Available

Research Sponsored by Megan Nicklay

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

DSBLongCOVID Trial Summary

This trial will assess if a nerve block can help reduce symptoms of long COVID.

Who is the study for?

This trial is for adults who've had COVID-19 and are now suffering from long-term symptoms like low blood pressure, digestive issues, or pain. They must have confirmed past COVID-19 with a test and ongoing symptoms for at least four weeks. People can't join if they're on blood thinners, have glaucoma, previous similar treatments, local anesthetic allergies, are pregnant, or have infections/masses where the injection would go.Check my eligibility

What is being tested?

The study is testing whether injecting a numbing medication called bupivacaine into nerves in the neck (stellate ganglion block) helps relieve chronic symptoms that some people experience after COVID-19.See study design

What are the potential side effects?

Possible side effects of the stellate ganglion block may include soreness at the injection site, light-headedness due to low blood pressure, difficulty swallowing temporarily and very rarely seizure if the drug spreads to nearby structures.

DSBLongCOVID Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ability to participate in social roles and activities status

Anxiety

Depression

+5 more

Secondary outcome measures

Autonomic Symptoms: COMPASS-31 Score

DSBLongCOVID Trial Design

1Treatment groups

Experimental Treatment

Group I: ActiveExperimental Treatment1 Intervention

This is a non-randomized, non-blinded study. Participants eligible for this study will receive active treatment. Dual Sympathetic Blocks of the stellate ganglion are minimally- invasive outpatient procedures performed under monitored care anesthesia (light sedation). Under ultrasound visualization, a small needle is guided into the neck region that contains the stellate ganglion nerve cluster at C6-C7. Once the needle position is confirmed, a local anesthetic (7 cc of 0.5% bupivacaine/Marcaine) is injected around the stellate ganglion by the Principal Investigator. This procedure is repeated at the C3-C4 level to block the superior cervical ganglion nerve cluster (3 cc of 0.5% bupivacaine/Marcaine).

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Megan NicklayLead Sponsor

Jonathann Kuo, MDLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Active compound been verified by the FDA?

"Since this is a preliminary phase 1 trial, the safety of Active was estimated to be at level one due to limited data on their efficacy and security."

Answered by AI

Are there any unfilled slots available in this research project?

"Affirmative. Per clinicaltrials.gov, this research initiative is actively accepting new participants. It was initially launched on December 1st 2022 and most recently amended on the same date, with a target of 20 patients at one single medical centre."

Answered by AI

Do I satisfy the qualifications to enroll in this clinical experiment?

"This clinical trial seeks 20 individuals, ranging between 18 to 100 years of age, who are suffering from dysautonomia. Qualifying patients must have had a confirmed COVID-19 diagnosis by RT-PCR or equivalent testing and display lingering symptoms four weeks after the start of the infection. The COMPASS-31 is used to quantify autonomic symptom domains such as Orthostatic Intolerance and Vasomotor Alterations while PROMIS-29 measures patient reported pain interference or intensity."

Answered by AI

Does this research permit elderly participants?

"The most recent review of the inclusion criteria specifies that patients must fall between 18-100 years old in order to participate. Separately, there are 947 separate clinical trials designed for minors and 3088 specifically tailored towards seniors."

Answered by AI