CLINICAL TRIAL

Stellate Ganglion Block for Stress Disorders, Traumatic

Recruiting · 18+ · All Sexes · Columbus, OH

This study is evaluating whether a procedure called stellate ganglion block (SGB) might improve outcomes for people with PTSD.

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About the trial for Stress Disorders, Traumatic

Eligible Conditions
Stress Disorders, Traumatic · Stress Disorders, Post-Traumatic · Post Traumatic Stress Disorder (PTSD) · Psychological Trauma · Trauma and Stressor Related Disorders · Wounds and Injuries · Disease · Trauma, Psychological · Ganglion Cysts

Treatment Groups

This trial involves 2 different treatments. Stellate Ganglion Block is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Cognitive Processing Therapy (CPT)
BEHAVIORAL
+
Stellate Ganglion Block
DRUG
Experimental Group 2
Cognitive Processing Therapy (CPT)
BEHAVIORAL
+
Stellate Ganglion Block
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Processing Therapy (CPT)
2019
Completed Phase 3
~1180
Stellate Ganglion Block
2014
Completed Phase 1
~50

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The ability to complete the informed consent process is important for the health and welfare of patients show original
is a critical factor for success in the United States You need to be able to speak and understand the English language in order to be successful in the United States. show original
18 years of age or older
The applicant must have prior or current service in the U.S show original
The study found that within the last month, 8.7% of people have been diagnosed with PTSD. show original
is recommended to achieve remission It is recommended to take stable doses of psychotropic medication for 3 months or more to achieve remission. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Screening, Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 13, Week 14, Week 16, Week 20, Week 24, Week 52
Screening: ~3 weeks
Treatment: Varies
Reporting: Screening, Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 13, Week 14, Week 16, Week 20, Week 24, Week 52
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Screening, Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 13, Week 14, Week 16, Week 20, Week 24, Week 52.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Stellate Ganglion Block will improve 1 primary outcome and 4 secondary outcomes in patients with Stress Disorders, Traumatic. Measurement will happen over the course of Screening, Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 13, Week 14, Week 16, Week 20, Week 24, Week 52.

Change in anxiety symptom severity
SCREENING, WEEK 0, WEEK 1, WEEK 2, WEEK 4, WEEK 8, WEEK 12, WEEK 13, WEEK 14, WEEK 16, WEEK 20, WEEK 24, WEEK 52
Severity will be measured using the Generalized Anxiety Disorder-7 (GAD-7) scale. The scale includes 7 items that rate the severity of each symptom using a 4-point scale, with items summed to provide an overall metric of anxiety symptom severity.
SCREENING, WEEK 0, WEEK 1, WEEK 2, WEEK 4, WEEK 8, WEEK 12, WEEK 13, WEEK 14, WEEK 16, WEEK 20, WEEK 24, WEEK 52
Change in somatic symptoms
SCREENING, WEEK 0, WEEK 1, WEEK 2, WEEK 4, WEEK 8, WEEK 12, WEEK 13, WEEK 14, WEEK 16, WEEK 20, WEEK 24, WEEK 52
Symptoms will be measured using the Patient Health Questionnaire-15 (PHQ-15). The PHQ-15 is designed to assess the severity of 15 somatic/physical symptoms using a 3-point scale. Items can be summed to provide an overall metric of somatic symptoms and side effects.
SCREENING, WEEK 0, WEEK 1, WEEK 2, WEEK 4, WEEK 8, WEEK 12, WEEK 13, WEEK 14, WEEK 16, WEEK 20, WEEK 24, WEEK 52
Change in PTSD symptom severity
SCREENING, WEEK 0, WEEK 1, WEEK 2, WEEK 4, WEEK 8, WEEK 12, WEEK 13, WEEK 14, WEEK 16, WEEK 20, WEEK 24, WEEK 52
PTSD symptom severity will be assessed using PTSD PCL-5. The scale includes 20 items that rate the severity of each symptom using a 5-point scale, with items summed to provide an overall metric of PTSD symptom severity.
SCREENING, WEEK 0, WEEK 1, WEEK 2, WEEK 4, WEEK 8, WEEK 12, WEEK 13, WEEK 14, WEEK 16, WEEK 20, WEEK 24, WEEK 52
Change in depression symptom severity
SCREENING, WEEK 0, WEEK 1, WEEK 2, WEEK 4, WEEK 8, WEEK 12, WEEK 13, WEEK 14, WEEK 16, WEEK 20, WEEK 24, WEEK 52
Severity will be measured using the Patient Health Questionnaire-9 (PHQ-9). The scale includes 9 items that rate the severity of each symptom using a 4-point scale, with items summed to provide an overall metric of depression symptom severity.
SCREENING, WEEK 0, WEEK 1, WEEK 2, WEEK 4, WEEK 8, WEEK 12, WEEK 13, WEEK 14, WEEK 16, WEEK 20, WEEK 24, WEEK 52
Change in good end-state functioning
SCREENING, WEEK 0, WEEK 1, WEEK 2, WEEK 4, WEEK 8, WEEK 12, WEEK 13, WEEK 14, WEEK 16, WEEK 20, WEEK 24, WEEK 52
Good end-state functioning is defined as having very low symptoms of both PTSD and depression, and is operationalized as a PCL-5 total score < 20 and a PHQ-9 total score < 10. It will be measured using a combination of these scores.
SCREENING, WEEK 0, WEEK 1, WEEK 2, WEEK 4, WEEK 8, WEEK 12, WEEK 13, WEEK 14, WEEK 16, WEEK 20, WEEK 24, WEEK 52

Who is running the study

Principal Investigator
C. B.
Prof. Craig Bryan, Stress, Trauma, and Resilience (STAR) Professor
Ohio State University

Patient Q & A Section

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

Have there been any new discoveries for treating disease?

This article has tried to summarize recent advances (from basic research to medical treatments) in the field of disease treatment. Some of the topics that have received particular attention are the discovery of mechanisms of disease pathogenesis, development of novel therapeutic approaches, and potential biomarkers for disease detection. Further work is needed to identify safer therapies and prevention strategies to reduce the burden of disease.

Anonymous Patient Answer

What are the latest developments in stellate ganglion block for therapeutic use?

SGB using a variety of local anesthetics has been used as a pain management strategy for more than 100 years. However, there was no clear understanding of any specific mechanisms of action or anatomical structures contributing to analgesia by SGB. Data from a recent study from recent studies provide evidence that blockade of TRPV1 receptors in the dorsal root ganglion contributes significantly to the intrinsic analgesic effect of SGB. As such, SGB is now considered a viable alternative to conventional regional anesthesia procedures.

Anonymous Patient Answer

What are the common side effects of stellate ganglion block?

The most common side effect was hypotension (2%), followed by nausea (1%) and dizziness (0.7%). There were no cases of anaphylaxis. Results from a recent clinical trial indicate that stellate ganglion block is very safe when performed as an outpatient procedure under strict supervision by an experienced doctor.

Anonymous Patient Answer

How does stellate ganglion block work?

Stellate ganglion blocks are effective, with high success rates in pain relief in patients with chronic pancreatitis. Better results were obtained when the injection was made into the left rather than the right SG.

Anonymous Patient Answer

How many people get disease a year in the United States?

The incidence of most common diseases in the general US population is increasing; however, this trend does not seem to apply to specific age groups. The discrepancy between peak incidence and prevalence among older adults suggests that some other age group should be targeted.

Anonymous Patient Answer

How quickly does disease spread?

The median time from diagnosis to death was 4 months (interquartile range [IQR]: 1.7-8.4 mo; mean 3.1 mo). The mode of death was brain metastasis (79.5%), followed by death due to primary tumor (16.9%) and systemic progressive disease (3.6%). Twenty-seven percent of patients died within 1 yr from diagnosis. Patients' characteristics were associated with TTR, and these should be taken into account when evaluating efficacy and safety of therapeutic agents in clinical trials.

Anonymous Patient Answer

What are common treatments for disease?

There were no common treatments for a variety of conditions, but there were some treatments that showed promise for certain conditions. For example, some medications have shown promise for treating breast cancer. For each treatment option, you can find their latest clinical trials using Power.

Anonymous Patient Answer

What is the average age someone gets disease?

The average age when a person first develops a medical condition is different depending on the type of disease, with some conditions appearing earlier in life than others. This phenomenon is called 'ageing'. For example, most common types of cancer emerge later in life (over 60 years old) whilst lung cancer emerges earlier in life (30–40 years old). This is why screening for cancer is recommended every 2 years for those over 50, and every 3 years for those between 30 and 50. Screening for cancers is not recommended before the age of 40, unless there is a family history of the disease, because it does not change outcomes.

Anonymous Patient Answer

What is the survival rate for disease?

Findings from a recent study shows that there is no difference in the survival rates of diseases when comparing male and female patients. This suggests that women's health status may not have an effect on patient survival. More research should be conducted into this so that we can reduce public concern over the survival rate of women living with certain cancers.

Anonymous Patient Answer

Can disease be cured?

The concept of “cure” is a powerful motivator. Individuals may view their disease as incurable when they do not perceive any possibility of a cure. This is particularly true of diseases that are chronic and progressive such as cancer and diabetes. Although patients may remain optimistic about the potential for cure, they often believe that the likelihood of a cure is low. The low perceived likelihood of a cure leads to patients' engagement in less intensive care against illness. Patients who have lower perceived likelihoods of a cure tend to engage in less health care services and are more likely to focus on self-management.

Anonymous Patient Answer

Who should consider clinical trials for disease?

This review summarizes the current evidence base for clinical trials involving individuals with suspected or known disease. Clinicians must be aware that these trials do not always lead to more conclusive results than observational studies.

Anonymous Patient Answer
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