Efficacy of Cervical Sympathetic Blocks for PTSD

NCT07087015 | Not Yet Recruiting

• 1 other identifier: 81697
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Millions of people suffer from anxiety disorders, including posttraumatic stress disorder (PTSD)-a condition that can profoundly disrupt daily life. Although treatments like therapy and medication help many, there is still a major need for more effective and faster-acting options. In recent studies, a procedure called cervical sympathetic block (CSB)-an injection near a nerve cluster in the neck-has shown promise in reducing PTSD symptoms, as measured by standardized tools like the CAPS (Clinician-Administered PTSD Scale). In this study, the investigators will conduct a double-blind, randomized controlled trial comparing CSB to a sham (placebo) injection in patients with PTSD. The investigators will assess changes in PTSD symptoms and also monitor physiological markers (like pupil response, temperature, and heart rate variability) to better understand how the treatment works and to improve the precision of future therapies.

Conditions

PTSD

Keywords

cervical sympathetic nerve bock; regional anesthesia; neuromodulation; sympathetic blockade

Outcome Measures

Primary Outcomes (1)

• Clinician-Administered PTSD Scale (CAPS-5) scores

  CAPS-5 score is used to establish severity of PTSD. It is a 30-item structured interview that assesses the 20 DSM-5 PTSD symptoms, as well as associated features, the onset and duration of symptoms, global severity, symptom impact, improvement in symptoms, and a validity check. The resulting values range from 0 to 80, with the higher scores indicating worse PTSD symptom severity.

  Baseline (1 month before the block), 30 and 90 days post-block.

Secondary Outcomes (19)

• Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) scores

  Baseline (1 month before the block), then 7, 14, 30 and 90 days post-block

• Patient Health Questionnaire-9 (PHQ-9)

  2 weeks before the block and 2 weeks post-block

• State and Trait Anxiety Scale (STAI)

  2 weeks before the block and 2 weeks post-block

• Generalized Anxiety Disorder scale (GAD-7)

  2 weeks before the block and 2 weeks post-block

• Positive and Negative Affect Schedule (PANAS)

  2 weeks before the block and 2 weeks post-block

Study Arms (2)

Intervention Group (CSB)

EXPERIMENTAL

Patients will receive an ultrasound guided cervical sympathetic block. The block procedure consists of the deposition of local anesthetic under ultrasound guidance at the level of the cervical sympathetic ganglia.

Procedure: Cervical sympathetic nerve block; Drug: Ropivacaine

Control group

SHAM COMPARATOR

Patients will receive a subcutaneous sham injection with saline. Ultrasound imaging will be used to simulate the guidance process as in the active procedure, maintaining consistency in the procedural experience.

Procedure: Subcutaneous sham injection; Drug: Normal Saline

Interventions

Cervical sympathetic nerve block PROCEDURE

Patients will receive a CSB.

Intervention Group (CSB)

Subcutaneous sham injection PROCEDURE

Patients will receive a subcutaneous sham injection of saline.

Control group

Ropivacaine DRUG

The CSB group will receive ropivacaine 0.5% 10ml.

Intervention Group (CSB)

Normal Saline DRUG

The control group will receive 3 ml of normal saline in the sham injection.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 to 70 years of age, inclusive, at screen.
• Able to read, understand, and provide written informed consent in English prior to screening, and likely to comply with study procedures and communicate effectively with study personnel regarding adverse events or other clinically important information.
• Diagnosed with PTSD prior to screening, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition. The diagnosis of PTSD will be made by a trained study staff member and supported by the Structured Clinical Interview for DSM Disorders (SCID).
• Meet the threshold of CAPS-5 score of \>20 during screening.
• Concurrent psychotherapy will be allowed if the type (e.g., supportive, cognitive behavioral, insight-oriented, et al) and frequency (e.g., weekly or monthly) of the therapy has been stable for at least 4 weeks prior to screening and if the type and frequency of the therapy is expected to remain stable during the course of the subject's participation in the study.
• Concurrent antidepressant therapy (e.g. SSRI or SNRI) will be allowed if the therapy has been stable for at least 4 weeks prior to screening and if it is expected to remain stable during the course of the subject's participation in the study.
• In sufficiently good health to proceed with a low-risk elective procedure, characterized using the American Society of Anesthesiologists (ASA) physical status classification system as Class I, II, or III.
• ASA Class III participants whose functional impairment is directly related to a psychiatric diagnosis (depression, anxiety or PTSD) will be included.

You may not qualify if:

• Allergy to local anesthetics
• Severe coagulopathy
• Female that is pregnant or breastfeeding.
• Female with a positive pregnancy test at screening or baseline.
• Total CAPS-5 score £20 at screening.
• Current diagnosis of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated "moderate" or "severe" per criteria of the SCID, or Alcohol Use Disorder rated "moderate" or "severe" per SCID criteria. The following categories of SUD will NOT be excluded: nicotine dependence; alcohol or substance use disorder rated "mild"; alcohol or substance use disorder of any severity in remission, either early (3-12 months) or sustained (\>12 months) time frames.
• Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Specific Phobia, or Bipolar II Disorder (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more)
• History of schizophrenia or schizoaffective disorders, or a psychotic disorder as defined by SCID interview.
• Any Axis I or Axis II Disorder, which at screening is clinically predominant to their PTSD or has been predominant to their PTSD at any time within six months prior to screening.
• In the judgment of the investigator, the subject is at significant risk for suicidal behavior during the course of his/her participation in the study.
• A neurological disorder including:
• Has dementia, delirium, amnestic, or any other cognitive disorder
• Encephalitis, meningitis, degenerative central nervous system disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, mental retardation
• Any other disease/accident/intervention associated with significant injury to or malfunction of the central nervous system with ongoing clinically significant sequelae, or in the view of the investigator poses a risk for participation in this study.
• A cardiovascular disorder including:

Sponsors & Collaborators

• Stanford University: lead

Related Publications (2)

• Zhang J, Liu Y, Li H, Hu Y, Yu S, Liu Q, Chen Y. Stellate Ganglion Block Improves Postoperative Cognitive Dysfunction in aged rats by SIRT1-mediated White Matter Lesion Repair. Neurochem Res. 2022 Dec;47(12):3838-3853. doi: 10.1007/s11064-022-03800-z. Epub 2022 Oct 31.

  PMID: 36315371 BACKGROUND

• Yu K, Zhang XK, Xiong HC, Liang SS, Lu ZY, Wu YQ, Chen Y, Xiao SJ. Stellate ganglion block alleviates postoperative cognitive dysfunction via inhibiting TLR4/NF-kappaB signaling pathway. Neurosci Lett. 2023 Jun 11;807:137259. doi: 10.1016/j.neulet.2023.137259. Epub 2023 Apr 17.

  PMID: 37075883 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Anna Maria Bombardieri, MD, PhD

CONTACT

(650) 723-6412; abomba@stanford.edu

Ksenia Kasimova, MD

CONTACT

6507889458; kasimova@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Twenty patients will be enrolled, with 10 patients allocated to each study arm (treatment and control).

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share