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Procedure

Experimental: Stellate Ganglion Block for Parosmia

Phase 2

Recruiting

Led By Nyssa Farrell, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Adults age 18 to 70

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month, 3 month

Awards & highlights

Study Summary

This trial aims to study the effects of a treatment called stellate ganglion block on people who have lost their sense of smell due to COVID-19. Loss of smell can have a big impact

Who is the study for?

This trial is for individuals who have persistent smell disorders, like loss of smell or distorted smells (parosmia), after a COVID-19 infection. Up to 140 participants with these long-lasting symptoms can join the study.Check my eligibility

What is being tested?

The trial is testing whether a Stellate Ganglion Block, which involves an injection that may reset nerve function, is more effective than a placebo sham injection at improving the sense of smell in people with post-COVID olfactory dysfunction.See study design

What are the potential side effects?

Potential side effects from the Stellate Ganglion Block could include soreness or bruising at the injection site, temporary changes in voice or swallowing, and rarely more serious complications related to nerve blocks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month, 3 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month, 3 month

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

Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR)

Secondary outcome measures

Assessment of the Blind

Clinical Global Impression - Improvement Scale (CGI-I)

Clinical Global Impression - Severity Scale (CGI-S)

+6 more

Other outcome measures

Adverse Events Assessment

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Experimental: Stellate Ganglion BlockActive Control1 Intervention

The ultrasound guided stellate ganglion blocks will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these blocks. Laterality of the stellate ganglion blocks will be randomized between the left and right sides of the neck.

Group II: Placebo: Sham InjectionPlacebo Group1 Intervention

The ultrasound guided placebo sham injections will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these injections. Laterality of the placebo sham injections will be randomized between the left and right sides of the neck.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,555 Total Patients Enrolled

3 Trials studying Parosmia

96 Patients Enrolled for Parosmia

Nyssa Farrell, MDPrincipal InvestigatorDepartment of Otolaryngology - Head and Neck Surgery, Division of Rhinology and Anterior Skull Base Surgery, Washington University School of Medicine

Frequently Asked Questions

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

What is the current number of participants being admitted into this research trial?

"Indeed, the details on clinicaltrials.gov show that recruitment for this trial is ongoing. The initial posting of the trial was on October 25, 2023, with the most recent update made on February 9, 2024. A total of 140 individuals are being sought at a single designated site."

Answered by AI

What are the risks associated with Experimental: Stellate Ganglion Block for individuals undergoing this procedure?

"The safety evaluation from Power's team for the Experimental: Stellate Ganglion Block is a 2, as it falls within a Phase 2 trial. At this stage, there exists preliminary safety data without evidence of efficacy yet."

Answered by AI

Is the study open to participants younger than 85 years of age?

"This study is seeking individuals over 18 years of age but under the age of 70 to participate."

Answered by AI

Are there still available slots for patients to participate in this ongoing clinical trial?

"Indeed, information from clinicaltrials.gov confirms that this investigation is actively seeking volunteers. Initially shared on October 25th, 2023, the post was last revised on February 9th, 2024. The aim is to recruit approximately 140 participants from a single site."

Answered by AI

Recent research and studies

Plos OneJournal

Persisting Olfactory Dysfunction in Post-covid-19 Is Associated with Gustatory Impairment: Results from Chemosensitive Testing Eight Months After the Acute Infection

Hintschich, Constantin A., René Fischer, Thomas Hummel, Jürgen J. Wenzel, Christopher Bohr, and Veronika Vielsmeier. 2022. “Persisting Olfactory Dysfunction in Post-covid-19 Is Associated with Gustatory Impairment: Results from Chemosensitive Testing Eight Months After the Acute Infection”. Edited by John I. Glendinning. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0265686.

JAMA Otolaryngology–Head & Neck SurgeryJournal

Association of Olfactory Impairment with All-cause Mortality

Pang, Natalie Yan-Lin, Harris Jun Jie Muhammad Danial Song, Benjamin Kye Jyn Tan, Jun Xiang Tan, Ashley Si Ru Chen, Anna See, Shuhui Xu, Tze Choong Charn, and Neville Wei Yang Teo. 2022. “Association of Olfactory Impairment with All-cause Mortality”. JAMA Otolaryngology–head & Neck Surgery. American Medical Association (AMA). doi:10.1001/jamaoto.2022.0263.

Journal of NeuroimmunologyJournal

Stellate Ganglion Block Reduces Symptoms of Long COVID: A Case Series

Liu, Luke D., and Deborah L. Duricka. 2022. “Stellate Ganglion Block Reduces Symptoms of Long COVID: A Case Series”. Journal of Neuroimmunology. Elsevier BV. doi:10.1016/j.jneuroim.2021.577784.

BMC Infectious DiseasesJournal