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Anti-Inflammatory Agents, Non-Steroidal

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Besides orally topiramate plus ibuprofen as standardized drug treatment, patients will also receive SGBs plus standardized drug therapy; SGB will be performed once a week for 4 consecutive times in an individual series. The interval of each separate SGB procedure is 1 week. Every time patients with bilateral headache will be administered SGB alternately on each side at an interval of 40 min, and patients with unilateral headache will be administered SGB on the ipsilateral side;

The patients will only receive Topiramate plus ibuprofen as standardized drug treatment according to the guidelines for the treatment of CM.

All SGB procedures will be performed by the same experienced physicians. Patients will be positioned in a supine position with the neck slightly hyperextended and receive a SGB procedure using the B-ultrasound visualization technique (Aurora A5 Ultrasound, Risco Tech Co., Ltd.). 1% lidocaine 5mL (Shanxi Jinxin Shuanghe Pharm Co., Ltd.) will be injected below the prevertebral fascia on the surface of longus colli muscle

Stellate Ganglion Block (SGB)

Topiramate(Topiramate, Xi'an Yangsen Pharmaceutical Co., Ltd) will be started at a low dose and then increased gradually until optimally effective, side effects become intolerable, or the maximum recommended dose is reached. During the 4-week up-titration phase, the intention will increase dose weekly in 25 mg increments with the aim of reaching 50-100 mg/day. Ibuprofen((Fenbid, Tianjin Shike Pharmaceutical Co., Ltd)will be chosen as acute treatment, but no more than 10 times per month to avoid medication overuse headache.

standardized drug treatment

Fang Luo, M.D

Lu Liu

To assess the 6-months effects and safety of stellate ganglion block(SGB) for Chronic Migraine (CM) patients who failure to undergo preventive therapy and are seeking a more suitable non-pharmacological therapy.

The investigators aim to investigate whether the stellate ganglion block(SGB) is better than traditional medication treatment and provides medical evidence for the clinical application and promotion of SGB to provide a minimally invasive, safe, and effective treatment for patients with chronic migraine(CM) who failed to receive standardized drug treatment.

Ultrasound-guided Stellate Ganglion Block for Treatment of Chronic Migraine in Adult

A Prospective, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Stellate Ganglion Block for CM Treatment

The primary outcome is the change from baseline in mean monthly (defined as 4 weeks) migraine days across 6-months follow-up period, which will be assessed by a blinded independent central review (BICR). Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A migraine day is defined as a calendar day with symptoms of a migraine attack lasting at least 30 min.

Proportion of patients achieved≥50% reduction

Total effective rate = cure rate + markedly effective rate + effective rate

The Numeric Rating Scale(NRS) scoring method typically uses a score range of 0-10, with 0 indicating no pain or symptoms and 10 indicating the most severe pain or symptoms.

Patients satisfaction (PS) evaluated by PS scores, which typically uses a score range of 0-10, with 0 indicating no patient satisfaction and 10 indicating the most patient satisfaction.

The six item headache impact test (HIT-6) is a self-reported questionnaire measuring the "impact that headaches have on the ability to function on the job, at school, at home, and in social situations.

MIDAS is a reliable and validated scale measuring migraine-related disability regarding the need for medical care.. Higher MIDAS scores indicate more days with disability

PSQI is a self-administered assessment of sleep disturbances that may affect sleep quality, including sleep apnoea, with a higher score indicating more severe sleep disturbances.

Proportion of participants with adverse events (AEs) and serious adverse events

Beijing Tiantan Hospital

Director of Department of Day surgery and Pain Management

Anesthetics

Anesthetics, Local

The sample will be composed of 30 patients from Stella's Chicago practice: 712 N Dearborn St, Chicago, Illinois 60654

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.

stellate ganglion block (SGB)

William von Hippel, PhD

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.

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.

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

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

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.

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.

Beck Depression Inventory-II. Scores from 0-63. Higher scores indicate more severe depression.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ultrasound-guided Stellate Ganglion Block for Treatment of Chronic Migraine in Adult	NCT06322407	Chronic Migrain...	Stellate Gangli... standardized dr...	18 Years - 65 Years	Beijing Tiantan Hospital
Effects of Stellate Ganglion Block and Superior Cervical Ganglion Block on Sleep and Recovery	NCT05470361	PTSD	stellate gangli...	18 Years - 95 Years	The University of Queensland
Effects of Stellate Ganglion Block and Superior Cervical Ganglion Block on Sleep and Recovery	NCT05470361	PTSD	stellate gangli...	18 Years - 95 Years	The University of Queensland

Spots Global Cancer Trial Database for stellate ganglion block (sgb)