DysphagiaSGBNCT06189560
Stellate Ganglion Block: A Breakthrough Treatment for Post-Stroke Pharyngeal Dysphagia
A study testing comprehensive rehabilitation and SGB in people with Dysphagia and Stellate Ganglion Block, run by Zeng Changhao at 1 site in China.
Trial summary
This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Dysphagia, Stellate Ganglion Block
- What is being tested?
- comprehensive rehabilitation and SGB
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2022to 17 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 30 and 80 years;
- New-onset stroke, confirmed by head CT or MRI;
- The course of disease between 1 to 6 months;
- With pharyngeal dysphagia shown by VFSS;
- Stable vital signs;
- Voluntary participation in the study.
Who cannot join
- Allergy to Lidocaine injection or vitamin B12 injection;
- Severe cognitive impairment;
- Coagulation disorders;
- Severe dysfunction of organs including heart, lungs, kidney, liver, etc.;
- Complicated with other neurological diseases;
- With severe oral dysphagia (results of the VFSS oral phase as 2 or 3 points);
- Dysphagia caused by other diseases or reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Random Controlled Study to Explore the Effect of Stellate Ganglion Block on Post-Stroke Pharyngeal Dysphagia
This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.
Read the detailed description
Dysphagia is a frequent and potentially serious complication of stroke. However, there is no effective measure for the treatment of pharyngeal dysphagia in stroke patients. This study aims to explore the efficacy of stellate ganglion block in post-stroke pharyngeal dysphagic patients who received comprehensive rehabilitation. This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.
- Conditions
- Dysphagia, Stellate Ganglion Block
- Being tested
- comprehensive rehabilitation, SGB
- Keywords
- Stellate ganglion block, Pharyngeal Dysphagia, Stroke, Rehabilitation, Swallowing disorder
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive rehabilitationBehavioural
All the participants were provided with the comprehensive rehabilitation (routine rehabilitation and swallowing function training). The routine rehabilitation included intervention for risk factors (blood pressure, blood lipids, blood glucose, smoking and alcohol restriction, exercise, etc.) and pharmacological treatment (aspirin, statins, anticoagulants, etc.).
Regrading swallowing function training, both groups were given swallowing function training, including 1) exercises of closure of the vocal folds, pharyngeal, and laryngeal muscles exercises, and respiratory muscle strength training, for 15 min each time and twice per day. 2) isotonic／isometric swallowing exercises, supraglottic swallowing exercises, and the Mendelsohn maneuver, for 20 min each time and twice per day. 3) effortful swallowing exercises, and cough reflex training, for 10 min each time and twice per day.
SGBDrug
the observation group was given SGB once a day, with 10 sessions as a course of treatment and each side of the body for one course. All the materials included: 1) 1.5ml of 2% Lidocaine hydrochloride injection (1ml: 0.5mg), Vitamin B12 Injection 500ug (1ml: 0.5g), the 5 ml disposable syringe and the sterile disposable dental injection needles. The specific operation procedure was as follows[16]: The operator stood at the patient\'s block side, and the patient was placed in the supine position, with the head leaning 45 degrees toward the contralateral side of the block side. After routine disinfection of the skin, a paratracheal approach was adopted, which was, 2.5cm above the sternoclavicular joint and 1.5cm outside the midline of the neck.
| Study group | Role | What they receive |
|---|---|---|
| The observation group | Experimental | Patients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days. Receives: Behavioral: comprehensive rehabilitation; Drug: SGB |
| The control group | Active comparator | Patients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days. Receives: Behavioral: comprehensive rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Video fluoroscopic swallowing study
The patient was required to take a sitting position with the head naturally upright. Under the guidance of the examiner, the patient first swallowed 5ml of iohexol solution (50ml:17.5g in iodine terms). If the patient exhibited aspiration, the test would stop. If not, the patient was instructed to swallow 10ml of iohexol solution mixed with breadcrumbs, and the patient's swallowing condition was observed with immediate measures ready to take for safety. Specially, the esophageal phase was not included in the study, because it was commonly regarded as an independent phase. The swallowing were divided into 3 phases in this assessment: Oral phase, Pharyngeal phase, and Aspiration, with maximum 3,3,4 points were given to each phase. The total score was calculated as the final result. The final score was positively correlated with the swallowing function.
Measured: day 1 and day 20
Secondary outcomes (2)
Kubota water swallowing test
During the test, patients were required to drink 30 ml of warm water. According to the situation, the swallowing function was rated from Level 1 (excellent) to Level 5 (poor). Specifically, Grade 1: The patient drank all the water at once without choking; Grade II: The patient drank all the water in two or more times without choking; Grade III: The patient drank all the water at once with choking; Grade IV: The patient drank all the water in two or more times with choking; Grade V: The patient exhibited difficulty drinking with frequent choking. Besides, we evaluated the efficacy as: 1) Recovery: The patient's symptoms of dysphagia disappear with grade 1 in the test. 2) Improvement: The patient shows improvement in dysphagia with the water the grade of the test improved. 3) Invalid: The patient's dysphagia deteriorates or did not improve, with the grade of the test not improved. (Overall effective rate = Recovery rate + Improvement rate).
Measured: day 1 and day 20
Rosenbek penetration-aspiration scale
Based on VFSS, this assessment evaluated the patient's swallowing of contrast medium and whether there was retention, penetration, and aspiration. It included multiple items, each with the corresponding criteria, Specifically, whether the swallowed material entered the airway, passed through or contacted the vocal cords, and whether the patient exhibited the corresponding ability to clear. There were 8 levels in the results, with higher levels indicating more severe aspiration.
Measured: day 1 and day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start21 Jun 2022
- Primary completion2 May 2023
- Study completion17 May 2023
Why it stopped: ethical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeng Changhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Changhao, People's Hospital of Zhengzhou University
- Investigators
- Nieto Luis, Master, Study director, Site Coordinator of United Medical Group located in Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189560
- Sponsor's protocol ID
- 2022-KY-0049-002
- Acronym
- SGB
- Status last verified
- Mar 2024
- First submitted
- 29 Nov 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and analyzed during the current study are not publicly available due to the hospital's confidentiality regulations regarding trial data but are available from the corresponding author on reasonable request.
Publications
GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
PubMed 34487721Gilman RH, Marquis GS, Miranda E, Vestegui M, Martinez H. Rapid reinfection by Giardia lamblia after treatment in a hyperendemic Third World community. Lancet. 1988 Feb 13;1(8581):343-5. doi: 10.1016/s0140-6736(88)91131-2.
PubMed 2893149Bejot Y, Bailly H, Graber M, Garnier L, Laville A, Dubourget L, Mielle N, Chevalier C, Durier J, Giroud M. Impact of the Ageing Population on the Burden of Stroke: The Dijon Stroke Registry. Neuroepidemiology. 2019;52(1-2):78-85. doi: 10.1159/000492820. Epub 2019 Jan 2.
PubMed 30602168Jones CA, Colletti CM, Ding MC. Post-stroke Dysphagia: Recent Insights and Unanswered Questions. Curr Neurol Neurosci Rep. 2020 Nov 2;20(12):61. doi: 10.1007/s11910-020-01081-z.
PubMed 33136216Zhang G, Li Z, Gu H, Zhang R, Meng X, Li H, Wang Y, Zhao X, Wang Y, Liu G; Chinese Stroke Center Alliance investigators. Dysphagia Management and Outcomes in Elderly Stroke Patients with Malnutrition Risk: Results from Chinese Stroke Center Alliance. Clin Interv Aging. 2022 Mar 17;17:295-308. doi: 10.2147/CIA.S346824. eCollection 2022.
PubMed 35321149Doi S, Cho N, Obara T. Stellate ganglion block increases blood flow in the anastomotic artery after superficial temporal artery-middle cerebral artery bypass. Br J Anaesth. 2016 Sep;117(3):395-6. doi: 10.1093/bja/aew230. No abstract available.
PubMed 27543535ter Laan M, van Dijk JM, Elting JW, Staal MJ, Absalom AR. Sympathetic regulation of cerebral blood flow in humans: a review. Br J Anaesth. 2013 Sep;111(3):361-7. doi: 10.1093/bja/aet122. Epub 2013 Apr 24.
PubMed 23616589Li TT, Wan Q, Zhang X, Xiao Y, Sun LY, Zhang YR, Liu XN, Yang WC. Stellate ganglion block reduces inflammation and improves neurological function in diabetic rats during ischemic stroke. Neural Regen Res. 2022 Sep;17(9):1991-1997. doi: 10.4103/1673-5374.335162.
PubMed 35142688
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Random Controlled Study to Explore the Effect of Stellate Ganglion Block on Post-Stroke Pharyngeal Dysphagia
- ClinicalTrials.gov ID
- NCT06189560
- Acronym / sponsor ID
- SGB / 2022-KY-0049-002
- Conditions
- Dysphagia, Stellate Ganglion Block
- Keywords
- Stellate ganglion block, Pharyngeal Dysphagia, Stroke, Rehabilitation, Swallowing disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: ethical issues
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Zeng ChanghaoUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.
Detailed description
Dysphagia is a frequent and potentially serious complication of stroke. However, there is no effective measure for the treatment of pharyngeal dysphagia in stroke patients. This study aims to explore the efficacy of stellate ganglion block in post-stroke pharyngeal dysphagic patients who received comprehensive rehabilitation. This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The observation group | Experimental | Behavioral: comprehensive rehabilitation, Drug: SGBPatients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days. |
| The control group | Active comparator | Behavioral: comprehensive rehabilitationPatients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 30 and 80 years;
- New-onset stroke, confirmed by head CT or MRI;
- The course of disease between 1 to 6 months;
- With pharyngeal dysphagia shown by VFSS;
- Stable vital signs;
Key exclusion criteria (7 listed)
- Allergy to Lidocaine injection or vitamin B12 injection;
- Severe cognitive impairment;
- Coagulation disorders;
- Severe dysfunction of organs including heart, lungs, kidney, liver, etc.;
- Complicated with other neurological diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comprehensive rehabilitationAll the participants were provided with the comprehensive rehabilitation (routine rehabilitation and swallowing function training). The routine rehabilitation included intervention for risk factors (blood pressure, blood lipids, blood glucose, smoking and alcohol restriction, exercise, etc.) and pharmacological treatment (aspirin, statins, anticoagulants, etc.). Regrading swallowing function training, both groups were given swallowing function training, including 1) exercises of closure of the vocal folds, pharyngeal, and laryngeal muscles exercises, and respiratory muscle strength training, for 15 min each time and twice per day. 2) isotonic／isometric swallowing exercises, supraglottic swallowing exercises, and the Mendelsohn maneuver, for 20 min each time and twice per day. 3) effortful swallowing exercises, and cough reflex training, for 10 min each time and twice per day. | Behavioural | The control group, The observation group |
| SGBthe observation group was given SGB once a day, with 10 sessions as a course of treatment and each side of the body for one course. All the materials included: 1) 1.5ml of 2% Lidocaine hydrochloride injection (1ml: 0.5mg), Vitamin B12 Injection 500ug (1ml: 0.5g), the 5 ml disposable syringe and the sterile disposable dental injection needles. The specific operation procedure was as follows[16]: The operator stood at the patient\'s block side, and the patient was placed in the supine position, with the head leaning 45 degrees toward the contralateral side of the block side. After routine disinfection of the skin, a paratracheal approach was adopted, which was, 2.5cm above the sternoclavicular joint and 1.5cm outside the midline of the neck. | Drug | The observation group |
Primary outcome
Video fluoroscopic swallowing study
Time frame: day 1 and day 20
The patient was required to take a sitting position with the head naturally upright. Under the guidance of the examiner, the patient first swallowed 5ml of iohexol solution (50ml:17.5g in iodine terms). If the patient exhibited aspiration, the test would stop. If not, the patient was instructed to swallow 10ml of iohexol solution mixed with breadcrumbs, and the patient's swallowing condition was observed with immediate measures ready to take for safety. Specially, the esophageal phase was not included in the study, because it was commonly regarded as an independent phase. The swallowing were divided into 3 phases in this assessment: Oral phase, Pharyngeal phase, and Aspiration, with maximum 3,3,4 points were given to each phase. The total score was calculated as the final result. The final score was positively correlated with the swallowing function.
2 secondary outcomes
Kubota water swallowing test
Time frame: day 1 and day 20
Rosenbek penetration-aspiration scale
Time frame: day 1 and day 20
Results and safety
The study was stopped early (reason given: ethical issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 34487721GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
- Background: PubMed 2893149Gilman RH, Marquis GS, Miranda E, Vestegui M, Martinez H. Rapid reinfection by Giardia lamblia after treatment in a hyperendemic Third World community. Lancet. 1988 Feb 13;1(8581):343-5. doi: 10.1016/s0140-6736(88)91131-2.
- Background: PubMed 30602168Bejot Y, Bailly H, Graber M, Garnier L, Laville A, Dubourget L, Mielle N, Chevalier C, Durier J, Giroud M. Impact of the Ageing Population on the Burden of Stroke: The Dijon Stroke Registry. Neuroepidemiology. 2019;52(1-2):78-85. doi: 10.1159/000492820. Epub 2019 Jan 2.
- Background: PubMed 33136216Jones CA, Colletti CM, Ding MC. Post-stroke Dysphagia: Recent Insights and Unanswered Questions. Curr Neurol Neurosci Rep. 2020 Nov 2;20(12):61. doi: 10.1007/s11910-020-01081-z.
- Background: PubMed 35321149Zhang G, Li Z, Gu H, Zhang R, Meng X, Li H, Wang Y, Zhao X, Wang Y, Liu G; Chinese Stroke Center Alliance investigators. Dysphagia Management and Outcomes in Elderly Stroke Patients with Malnutrition Risk: Results from Chinese Stroke Center Alliance. Clin Interv Aging. 2022 Mar 17;17:295-308. doi: 10.2147/CIA.S346824. eCollection 2022.
- Results publication: PubMed 27543535Doi S, Cho N, Obara T. Stellate ganglion block increases blood flow in the anastomotic artery after superficial temporal artery-middle cerebral artery bypass. Br J Anaesth. 2016 Sep;117(3):395-6. doi: 10.1093/bja/aew230. No abstract available.
- Results publication: PubMed 23616589ter Laan M, van Dijk JM, Elting JW, Staal MJ, Absalom AR. Sympathetic regulation of cerebral blood flow in humans: a review. Br J Anaesth. 2013 Sep;111(3):361-7. doi: 10.1093/bja/aet122. Epub 2013 Apr 24.
- Results publication: PubMed 35142688Li TT, Wan Q, Zhang X, Xiao Y, Sun LY, Zhang YR, Liu XN, Yang WC. Stellate ganglion block reduces inflammation and improves neurological function in diabetic rats during ischemic stroke. Neural Regen Res. 2022 Sep;17(9):1991-1997. doi: 10.4103/1673-5374.335162.
- Individual participant dataSharing planned: No. The datasets generated and analyzed during the current study are not publicly available due to the hospital's confidentiality regulations regarding trial data but are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nieto Luis, Master study director
Site Coordinator of United Medical Group located in Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comprehensive rehabilitation and SGB in people with Dysphagia and Stellate Ganglion Block, run by Zeng Changhao at 1 site in China.
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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was stopped early (reason given: ethical issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Video fluoroscopic swallowing study (time frame: day 1 and day 20). 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 NCT06189560, which also lists 8 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 5 Mar 2024.