Effects of Stellate Ganglion Block and Superior Cervical Ganglion Block on Sleep and Recovery

PTSD Clinical Trial

Official title:

Investigating the Effects of Stellate Ganglion Block and Superior Cervical Ganglion Block on Sleep and Recovery Using Biometric Capture Devices

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05470361
• Other study ID #: UQueenslandSGB
• Status: Not yet recruiting
• Start date: July 2022
• Est. completion date: July 2023

Study information

• Verified date: May 2022
• Source: The University of Queensland
• Contact: William von Hippel, PhD
• Phone: +614 2293 1198
• Email: billvh[@]psy.uq.edu.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to discover whether the Stellate Ganglion Block (SGB) plus the Superior Cervical Ganglion Block (SCGB) procedure is associated with improvements in heart rate variability and sleep quality as measured by the Whoop biometric capture device. It is predicted that after receiving the blocks, patients will show objectively improved measures of stress in the form of higher heart rate variability and improved sleep quality as well as improved subjective wellbeing.

Description:

PTSD is meaningfully related to workforce productivity and quality of life factors, including loss of employment and decreases in general life satisfaction. Trauma leads to symptoms that diminish capacity to experience warm and loving feelings for others (emotional numbness), profound negative changes in our self-image and identity, fears that often limit enjoyment of pleasurable activities, and other life-altering challenges. Many survivors experience recurrent feelings of helplessness and horror, and may commonly experience crippling panic attacks, feelings of self-blame and shame, chronically disrupted sleep, and relationship conflict with loved ones.

Low resting Heart Rate Variability (HRV)-- the variability in the time in between heart beats--is a physiological indicator of stress and has been associated with reductions in wellbeing and increases in all-cause mortality. Higher heart rate variability is associated with better sleep quality while lower heart rate variability is associated with increased chronic inflammation. The negative effects of PTSD on sleep are well-documented, and interventions are often targeted at alleviating this damaging consequence, as insufficient sleep can perpetuate anxiety and impair day-to-day functioning, leading to an overall reduced quality of life.

The current standard of care is to offer a combination of trauma-focused psychotherapy and symptom-focused medications, typically a selective serotonin reuptake inhibitor medication. However, a promising treatment known as the Stellate Ganglion Block (SGB) plus the Superior Cervical Ganglion Block (SCGB) procedure has been shown to alleviate PTSD symptoms without any of the side-effects and barriers known to patients on conventional treatments. While this treatment shows promise, most of the research performed so far has used subjective self-report measures of sleep quality and stress. Whoop biometric capture devices offer an opportunity to objectively measure sleep quality and heart rate variability to investigate the effects of the SGB. Physiological data could reveal whether this treatment works not just to alleviate subjective stress, but to physically reduce the effects of PTSD on the body.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• PTSD Symptoms

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Ganglion Cysts
• PTSD

Intervention

Procedure:
• stellate ganglion block (SGB)
The protocol for the SGB plus SCGB will be followed, wherein participants are given right-side procedures followed by left-side procedures on a different day if no initial improvement is seen. This procedure is carried out by injecting a local anesthetic into the neck to target the Stellate Ganglion and Superior Cervical Ganglion nerve bundles.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
The University of Queensland	Stella MSO, LLC, WHOOP Inc.

References & Publications (20)

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Bernardy NC, Friedman MJ. Psychopharmacological strategies in the management of posttraumatic stress disorder (PTSD): what have we learned? Curr Psychiatry Rep. 2015 Apr;17(4):564. doi: 10.1007/s11920-015-0564-2. Review. — View Citation

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Kim HG, Cheon EJ, Bai DS, Lee YH, Koo BH. Stress and Heart Rate Variability: A Meta-Analysis and Review of the Literature. Psychiatry Investig. 2018 Mar;15(3):235-245. doi: 10.30773/pi.2017.08.17. Epub 2018 Feb 28. Review. — View Citation

Lipov EG, Joshi JR, Lipov S, Sanders SE, Siroko MK. Cervical sympathetic blockade in a patient with post-traumatic stress disorder: a case report. Ann Clin Psychiatry. 2008 Oct-Dec;20(4):227-8. doi: 10.1080/10401230802435518. — View Citation

Lynch JH, Mulvaney SW, Kim EH, de Leeuw JB, Schroeder MJ, Kane SF. Effect of Stellate Ganglion Block on Specific Symptom Clusters for Treatment of Post-Traumatic Stress Disorder. Mil Med. 2016 Sep;181(9):1135-41. doi: 10.7205/MILMED-D-15-00518. — View Citation

Miller JV, Andre Q, Timmers I, Simons L, Rasic N, Lebel C, Noel M. Subclinical post-traumatic stress symptomology and brain structure in youth with chronic headaches. Neuroimage Clin. 2021;30:102627. doi: 10.1016/j.nicl.2021.102627. Epub 2021 Mar 13. — View Citation

Muldoon OT, Lowe RD, Jetten J, Cruwys T, Haslam SA. Personal and Political: Post-Traumatic Stress Through the Lens of Social Identity, Power, and Politics. Polit Psychol. 2021 Jun;42(3):501-533. doi: 10.1111/pops.12709. Epub 2020 Dec 13. — View Citation

Mulvaney SW, Lynch JH, Hickey MJ, Rahman-Rawlins T, Schroeder M, Kane S, Lipov E. Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. Mil Med. 2014 Oct;179(10):1133-40. doi: 10.7205/MILMED-D-14-00151. — View Citation

Rae Olmsted KL, Bartoszek M, Mulvaney S, McLean B, Turabi A, Young R, Kim E, Vandermaas-Peeler R, Morgan JK, Constantinescu O, Kane S, Nguyen C, Hirsch S, Munoz B, Wallace D, Croxford J, Lynch JH, White R, Walters BB. Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):130-138. doi: 10.1001/jamapsychiatry.2019.3474. Erratum in: JAMA Psychiatry. 2020 Jan 2;:. Erratum in: JAMA Psychiatry. 2020 Sep 1;77(9):982. — View Citation

Rauch SA, Eftekhari A, Ruzek JI. Review of exposure therapy: a gold standard for PTSD treatment. J Rehabil Res Dev. 2012;49(5):679-87. Review. — View Citation

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Ryff, C. D. (1989). Happiness is everything, or is it? Explorations on the meaning of psychological well-being. Journal of Personality and Social Psychology, 57(6), 1069.

Schoenfeld FB, Marmar CR, Neylan TC. Current concepts in pharmacotherapy for posttraumatic stress disorder. Psychiatr Serv. 2004 May;55(5):519-31. Review. — View Citation

Stein PK, Pu Y. Heart rate variability, sleep and sleep disorders. Sleep Med Rev. 2012 Feb;16(1):47-66. doi: 10.1016/j.smrv.2011.02.005. Epub 2011 Jun 11. Review. — View Citation

von der Warth R, Dams J, Grochtdreis T, König HH. Economic evaluations and cost analyses in posttraumatic stress disorder: a systematic review. Eur J Psychotraumatol. 2020 May 29;11(1):1753940. doi: 10.1080/20008198.2020.1753940. Review. — View Citation

Weathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P. A., Marx, B. P., & Schnurr, P. P. (2013). The ptsd checklist for dsm-5 (pcl-5). Scale available from the National Center for PTSD at www. ptsd. va. gov, 10(4).

Williams DP, Koenig J, Carnevali L, Sgoifo A, Jarczok MN, Sternberg EM, Thayer JF. Heart rate variability and inflammation: A meta-analysis of human studies. Brain Behav Immun. 2019 Aug;80:219-226. doi: 10.1016/j.bbi.2019.03.009. Epub 2019 Mar 11. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Quality	The primary outcome measures for the study will be participant sleep scores (derived from time spent in each sleep stage) and Heart Rate Variability, both of which will be measured by a Whoop strap biometric capture device. Higher heartrate variability represents a better outcome (healthier nervous system). Likewise a higher sleep score represents a better and more complete recovery.	8 weeks
Secondary	Self-reported Post-Traumatic Stress Disorder symptoms	Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorder (DSM-5). Scores range from 0-80. Higher scores mean worse Post-Traumatic Stress Disorder.	8 weeks
Secondary	Self-reported depression symptoms	Beck Depression Inventory-II. Scores from 0-63. Higher scores indicate more severe depression.	8 weeks