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PTSDNCT07087015

Efficacy of Cervical Sympathetic Blocks for PTSD

A study testing Cervical sympathetic nerve block, Ropivacaine and Normal Saline in people with PTSD, run by Stanford University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
PTSD
What is being tested?
Cervical sympathetic nerve block, Ropivacaine and Normal Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
No sites listed yet
Study dates
Oct 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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:
  • Uncontrolled hypertension
  • Congestive heart failure NYHA Criteria >Stage 2
  • Atrial fibrillation or resting heart rate <50 or >105 beats per minute at screening or randomization
  • Any clinically significant conduction abnormalities (eg 2nd degree AV nodal block or left bundle branch block)
  • QTcF (Fridericia-corrected) >= 450 msec at screening or randomization
  • Any cardiovascular disorder that would merit categorization of patient as ASA Class III or higher
  • A pulmonary/respiratory disorder including:
  • Diagnosed Obstructive Sleep Apnea or STOPBANG score of 5 or higher
  • History of difficult airway in surgical setting
  • Any pulmonary / respiratory disorder that would merit categorization of patient as ASA Class III or higher
  • Clinically significant liver disease, determined by LFTs within the past 6 months.
  • Clinically significant kidney disease determined by GFR (<40 mL/min, Cockcroft-Gault Equation)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Anna Maria Bombardieri, MD, PhD contact

(650) 723-6412

abomba@stanford.edu

Ksenia Kasimova, MD contact

6507889458

kasimova@stanford.edu

About this study

Official title: Efficacy of Cervical Sympathetic Blocks for Post-traumatic Stress Disorder: a Randomized Control Trial

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.

Read the detailed description

The investigators aim to determine whether cervical sympathetic blocks (CSBs) can reduce symptoms of posttraumatic stress disorder (PTSD). If effective, this approach could offer a rapid, legal, and scalable intervention for mental health conditions, in contrast with emerging psychedelic therapies. This research has the potential to transform treatment practices for PTSD and related disorders by providing a controlled, procedure-based option that modulates the autonomic nervous system. In addition to assessing symptom relief, the study will explore physiologic markers of sympathetic modulation, which may help identify objective indicators of treatment success. This could deepen our understanding of the neural mechanisms underlying PTSD and mental health more broadly, with implications for neuroscience, psychology, and clinical care.

Conditions
PTSD
Being tested
Cervical sympathetic nerve block, Subcutaneous sham injection, Ropivacaine, Normal Saline
Keywords
cervical sympathetic nerve bock, regional anesthesia, neuromodulation, sympathetic blockade
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervical sympathetic nerve blockProcedure or surgery

    Patients will receive a CSB.

  • Subcutaneous sham injectionProcedure or surgery

    Patients will receive a subcutaneous sham injection of saline.

  • RopivacaineDrug

    The CSB group will receive ropivacaine 0.5% 10ml.

  • Normal SalineDrug

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

Study groups in NCT07087015
Study groupRoleWhat they receive
Intervention Group (CSB)ExperimentalPatients 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.
Receives: Procedure: Cervical sympathetic nerve block; Drug: Ropivacaine
Control groupSham comparatorPatients 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.
Receives: Procedure: Subcutaneous sham injection; Drug: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (19)
  1. Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) scores

    PCL-5 is used to establish severity of self-rated symptoms of PTSD. It is a 20-item self-report measure that assesses the 20 DSM-5 PTSD symptoms. The resulting valuea range from 0 to 80, with the higher scores indicating worse PTSD symptom severity.

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

  2. Patient Health Questionnaire-9 (PHQ-9)

    A 9-item, self-administered instrument used to screen for the presence and severity of depression. Each item is scored from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 27. Higher scores indicate greater depressive symptom severity.

    Measured: 2 weeks before the block and 2 weeks post-block

  3. State and Trait Anxiety Scale (STAI)

    A 40-item self-report questionnaire designed to assess two types of anxiety: state anxiety (temporary condition in response to specific situations) and trait anxiety (general tendency to respond with anxiety). Each subscale (20 items each) is scored on a 4-point Likert scale, with higher scores indicating greater anxiety.

    Measured: 2 weeks before the block and 2 weeks post-block

  4. Generalized Anxiety Disorder scale (GAD-7)

    A 7-item self-report questionnaire used to assess the severity of generalized anxiety symptoms over the past two weeks. Each item is scored from 0 ("not at all") to 3 ("nearly every day"), yielding a total score ranging from 0 to 21. Higher scores indicate greater levels of anxiety.

    Measured: 2 weeks before the block and 2 weeks post-block

  5. Positive and Negative Affect Schedule (PANAS)

    A 20-item self-report questionnaire that measures two distinct dimensions of affect: Positive Affect (PA) and Negative Affect (NA). Respondents rate the extent to which they have experienced various emotions over a specified time frame using a 5-point Likert scale (1 = very slightly or not at all; 5 = extremely). Each subscale consists of 10 items, with higher scores indicating greater positive or negative affect.

    Measured: 2 weeks before the block and 2 weeks post-block

  6. Pittsburgh Sleep Quality Index (PSQI)

    A self-rated questionnaire that assesses sleep quality and disturbances over a 1-month period. It consists of 19 items generating seven component scores (e.g., sleep latency, duration, disturbances), which are summed to yield a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality.

    Measured: 2 weeks before the block and 2 weeks post-block

  7. The Satisfaction With Life Scale

    A 5-item self-report instrument designed to assess global cognitive judgments of one's overall life satisfaction. Each item is rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree), producing a total score ranging from 5 to 35. Higher scores indicate greater life satisfaction.

    Measured: 2 weeks before the block and 2 weeks post-block

  8. Scales of Psychological Well-Being

    A multidimensional self-report instrument designed to assess six key aspects of psychological well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Versions range from 18 to 84 items, with each dimension measured via Likert-scale items. Higher scores reflect greater well-being in each domain.

    Measured: 2 weeks before the block and 2 weeks post-block

  9. Peace of Mind Scale

    A brief self-report measure assessing an individual's inner peace and emotional calmness. The scale typically consists of 5 items rated on a 5-point Likert scale (1 = not at all; 5 = extremely true), with higher scores indicating a greater sense of peace and psychological stability.

    Measured: 2 weeks before the block and 2 weeks post-block

  10. The Emotion Regulation Questionnaire Short Form

    A 6-item self-report instrument that assesses two emotion regulation strategies: cognitive reappraisal (4 items) and expressive suppression (2 items). Each item is rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree), with higher scores indicating greater use of the respective strategy.

    Measured: 2 weeks before the block and 2 weeks post-block

  11. Harmony in Life Scale

    A 5-item self-report measure that assesses an individual's perceived harmony and balance in life. Items are rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree), with higher scores indicating greater harmony in life.

    Measured: 2 weeks before the block and 2 weeks post-block

  12. The Perth Alexithymia Questionnaire Short Form

    A 24-item self-report questionnaire designed to assess alexithymia, characterized by difficulties in identifying, describing, and processing emotions. The PAQ measures both general alexithymia and its specific facets across different emotional valences (positive and negative). Items are rated on a 7-point Likert scale, with higher scores indicating greater alexithymic traits.

    Measured: 2 weeks before the block and 2 weeks post-block

  13. Stanford Expectations of Treatment Scale (SETS)

    A brief self-report measure assessing patients' positive and negative expectations regarding treatment outcomes. The scale consists of 10 items rated on a 5-point Likert scale, capturing the extent of optimism or pessimism about the effectiveness of a given treatment. Higher scores reflect stronger positive expectations.

    Measured: 2 weeks before the block and 2 weeks post-block

  14. Columbia Suicidality Severity Rating Scale (CSSRS) Short Screen

    A brief clinician- or self-administered screening tool designed to assess the severity and immediacy of suicidal ideation and behavior. The short screen includes key items to quickly identify individuals at risk by evaluating recent suicidal thoughts, plans, and attempts. While the full C-SSRS has scoring and severity ratings, the short screen's primary use is as a binary screener (presence/absence of risk).

    Measured: 3 weeks before the block and days 1, 7, 14, 30, 90 post-block

  15. Adverse events

    The occurrence of adverse events will be collected.

    Measured: Days 1, 7, 14, 30, 90 post-block

  16. Sleep and Dream Log

    A self-reported daily diary in which participants record details about their sleep patterns and dream experiences. Typical entries include bedtime, wake time, sleep latency, number and duration of awakenings, subjective sleep quality, and dream recall or content. The log provides qualitative and quantitative data on sleep behavior and dream activity over the monitoring period.

    Measured: Daily starting from 2 weeks before the block and ending at 2 weeks post-block

  17. Daily Mood Questionnaire

    A brief self-report instrument completed daily to assess fluctuations in mood states. Participants rate their current mood or specific affective dimensions (e.g., happiness, sadness, anxiety, irritability) using Likert-type scales. The questionnaire captures short-term mood variability and overall emotional well-being throughout the study period.

    Measured: Daily starting from 2 weeks before the block and ending at 2 weeks post-block

  18. Home Sleep Monitoring

    Objective sleep data collected at home using the Muse EEG headband, a wearable device that records brainwave activity to assess sleep architecture and quality. The device measures parameters such as sleep onset latency, total sleep time, sleep stages (e.g., REM, deep sleep), and awakenings. Data are analyzed to provide quantitative metrics of sleep patterns in a naturalistic environment.

    Measured: Daily starting from 2 weeks before the block and ending at 2 weeks post-block

  19. Home-Based Polysomnography (PSG)

    Participants will come to the lab in the evening, where study staff will attach a portable PSG device. Participants will then return home via taxi and sleep while wearing the device. The next morning, they will return to the lab via taxi, where the study staff will remove the PSG.

    Measured: Three days before the block and 3 days post-block

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2025
  2. Study startOct 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Twenty patients will be enrolled, with 10 patients allocated to each study arm (treatment and control).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07087015
Sponsor's protocol ID
81697
Status last verified
Aug 2025
First submitted
18 Jul 2025
Last updated
26 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36315371
  • 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.

    PubMed 37075883

Questions about this trial

What is this clinical trial studying?

A study testing Cervical sympathetic nerve block, Ropivacaine and Normal Saline in people with PTSD, run by Stanford University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Maria Bombardieri, MD, PhD ((650) 723-6412, abomba@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinician-Administered PTSD Scale (CAPS-5) scores (time frame: Baseline (1 month before the block), 30 and 90 days post-block.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07087015, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.

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