Bulbar PalsyNCT06319534
Stellate Ganglion Block in Bulbar Palsy
A study testing Comprehensive rehabilitation, Stellate ganglion block and Lidocaine Hydrochloride in people with Bulbar Palsy, run by Zeng Xi at 6 sites in China.
Trial summary
This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. All patients are randomly allocated to the observation group or the control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bulbar Palsy
- What is being tested?
- Comprehensive rehabilitation, Stellate ganglion block and Lidocaine Hydrochloride
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 6 sitesChina
- Study dates
- 23 Mar 2024to 5 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
- Age >18 years.
- First-time stroke.
- Steady vital signs,
- Transferred or admitted to the Department of Rehabilitation Medicine within 15-30d after onset.
- No cognitive impairment or aphasia, with the Montreal Cognitive Assessment score ≥21 points.
- No history of severe mental illness or psychotropic drug dependence.
- Unsafe or insufficient oral intake, indicating the need for enteral feeding
Who cannot join
- Contraindications for Stellate Ganglion Block..
- Structural abnormalities of the oropharynx.
- Complicated with other neurological diseases.
- Tracheostomy tube inserted.
- Simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
- Dysphagia caused by other possible diseases.
- Pregnant females.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
zhongshan affiliated No.1 Hospital
Guandong
HLJ older people hospital
Heilongjiang
Lankao Renmen Hospital
Henan
NY zhongxin Hospital
Naning
People's Hospital of SN tequ
Suzhu
Department of rehabilitation medicine, the first ZU hospital north campus
Zhenzhou
About this study
Official title: A Randomized Controlled Study to Explore the Effect of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke
This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, ultrasound diagnostic devices, and penetration-aspiration scale, Flexible laryngoscope are used to assess swallowing function.
Read the detailed description
Palliation of dysphagia in patients with bulbar palsy after ischemic stroke continues to be a challenge.This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, ultrasound diagnostic devices, Flexible laryngoscope are used to assess swallowing function.
- Conditions
- Bulbar Palsy
- Being tested
- Comprehensive rehabilitation, Stellate ganglion block, Lidocaine Hydrochloride, placebo injection
- Medical subject headings
- Bulbar Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive rehabilitationBehavioural
All the participants are 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.).
Stellate ganglion blockProcedure or surgery
The percutaneous approach via the paratracheal route was used for Stellate ganglion block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck. The ultrasonic instrument is used to determine the position.
Lidocaine HydrochlorideDrug
the patients are provided with Stellate ganglion block, using 2.8ml of 0.8% Lidocaine hydrochloride and 0.2 ml of 0.5% vitamin B12. The percutaneous approach via the paratracheal route was used for Stellate ganglion block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck. The ultrasonic instrument is used to determine the position.
placebo injectionBehavioural
2.8 milliliter of normal saline will be used for injection. The percutaneous approach via the paratracheal route was used for Stellate ganglion block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck. The ultrasonic instrument is used to determine the position.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive rehabilitation+Stellate ganglion block | Experimental | Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days. Receives: Behavioral: Comprehensive rehabilitation; Procedure: Stellate ganglion block; Drug: Lidocaine Hydrochloride |
| Comprehensive rehabilitation+placebo | Placebo comparator | Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days. Receives: Behavioral: Comprehensive rehabilitation; Behavioral: placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Barium Swallow Impairment Profile
The Modified Barium Swallow Impairment Profile is used to evaluate the clinical severity of dysphagia. It consisted of 17 items. The total scores could range between 0 and 55, with higher scores indicating worse function.
Measured: day 1 before any intervention, day 11, and day 60
Secondary outcomes (7)
Murray secretion severity scale
Murray secretion severity scale is used for assessment of Pharyngeal secretion. The result was divided into 0-3 levels (0, normal; 1, a small amount of secretion remained and not entering the laryngeal vestibule; 2: temporary accumulation in the laryngeal vestibule; 3: persistent accumulation in the laryngeal vestibule. A higher score indicates the worse dysphagia.
Measured: day 1 before any intervention, day 11, and day 60
Yale pharyngeal residue severity rating scale
The Yale pharyngeal residue severity rating scale was recruited for assessment of Pharyngeal residue.The result would be divided into 5 levels (1, no residue; 2, the covered pharyngeal mucosa; 3, mild residue, less than 50%; 4, moderate residue, more than 50%; 5, severe residue, spillage from laryngeal vestibule observed). A higher score indicates the worse dysphagia.
Measured: day 1 before any intervention, day 11, and day 60
Penetration-Aspiration Scale
Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. As the level increased, the severity of dysphagia also increased.
Measured: day 1 before any intervention, day 11, and day 60
Generalized Anxiety Disorder 7-item scale
Generalized Anxiety Disorder 7-item scale was used to assess anxiety.The total score could range from 0 to 21, with higher scores indicating more severe anxiety.
Measured: day 1 before any intervention, day 11, and day 60
Movement distances of the hyoid bone
The lateral swallowing fluorography record was decomposed into individual images. Images were selected at both the resting positions and the maximum displacement. The distance of position change for the hyoid bone between the two images was measured with the inferior border of the C4 vertebra as a reference point. Then, the average movement distance was calculated and adopted.
Measured: day 1 before any intervention, day 11, and day 60
Vertebral artery cerebral blood flow velocity
The ultrasound diagnostic device was used to measure the internal diameter of the vertebral artery. The sample volume was then positioned at the center of the vessel and the angle between the ultrasound beam and the blood flow direction was kept within 60°. The Color Doppler ultrasound examination was performed to measure the mean blood flow velocity of the vertebral artery by continuously observing 10 cycles.
Measured: day 1 before any intervention, day 11, and day 60
Vertebral artery internal diameter
The ultrasound diagnostic device was used to measure the internal diameter of the vertebral artery. The sample volume was then positioned at the center of the vessel and the angle between the ultrasound beam and the blood flow direction was kept within 60°.
Measured: day 1 before any intervention, day 11, and day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start23 Mar 2024
- Primary completion5 Jun 2025
- Study completion5 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bulbar PalsyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeng Xi
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Zeng Xi, Chao Phya Abhaibhubejhr Hospital
- Investigators
- Nieto Luis, Study chair, Site Coordinator of United Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319534
- Sponsor's protocol ID
- SGB-ZHENQIU
- Status last verified
- May 2026
- First submitted
- 10 Mar 2024
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zeng H, Zhang W, Yang Y, Li Y, Wang S, Fang L, Wen C, Zhao W, Li D, Luo S, Zeng J, Wang X, Luo P, Li H, Wang L, Wang C, Zeng X. Effects of ultrasound-guided stellate ganglion block in poststroke bulbar palsy: a double-blind placebo-controlled trial. BMC Med. 2026 Mar 4;24(1):225. doi: 10.1186/s12916-026-04684-4.
PubMed 41782152
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Explore the Effect of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06319534
- Acronym / sponsor ID
- SGB-ZHENQIU
- Conditions
- Bulbar Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Zeng XiOther government
- Study start
- 23 Mar 2024 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jul 2025 (actual)
- First posted
- 20 Mar 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 is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, ultrasound diagnostic devices, and penetration-aspiration scale, Flexible laryngoscope are used to assess swallowing function.
Detailed description
Palliation of dysphagia in patients with bulbar palsy after ischemic stroke continues to be a challenge.This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, ultrasound diagnostic devices, Flexible laryngoscope are used to assess swallowing function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive rehabilitation+Stellate ganglion block | Experimental | Behavioral: Comprehensive rehabilitation, Procedure: Stellate ganglion block, Drug: Lidocaine HydrochloridePatients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days. |
| Comprehensive rehabilitation+placebo | Placebo comparator | Behavioral: Comprehensive rehabilitation, Behavioral: placebo injectionPatients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
- Age >18 years.
- First-time stroke.
- Steady vital signs,
- Transferred or admitted to the Department of Rehabilitation Medicine within 15-30d after onset.
Key exclusion criteria (7 listed)
- Contraindications for Stellate Ganglion Block..
- Structural abnormalities of the oropharynx.
- Complicated with other neurological diseases.
- Tracheostomy tube inserted.
- Simultaneously suffering from liver, kidney failure, tumors, or hematological 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 are 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.). | Behavioural | Comprehensive rehabilitation+Stellate ganglion block, Comprehensive rehabilitation+placebo |
| Stellate ganglion blockThe percutaneous approach via the paratracheal route was used for Stellate ganglion block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck. The ultrasonic instrument is used to determine the position. | Procedure or surgery | Comprehensive rehabilitation+Stellate ganglion block |
| Lidocaine Hydrochloridethe patients are provided with Stellate ganglion block, using 2.8ml of 0.8% Lidocaine hydrochloride and 0.2 ml of 0.5% vitamin B12. The percutaneous approach via the paratracheal route was used for Stellate ganglion block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck. The ultrasonic instrument is used to determine the position. | Drug | Comprehensive rehabilitation+Stellate ganglion block |
| placebo injection2.8 milliliter of normal saline will be used for injection. The percutaneous approach via the paratracheal route was used for Stellate ganglion block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck. The ultrasonic instrument is used to determine the position. | Behavioural | Comprehensive rehabilitation+placebo |
Primary outcome
Modified Barium Swallow Impairment Profile
Time frame: day 1 before any intervention, day 11, and day 60
The Modified Barium Swallow Impairment Profile is used to evaluate the clinical severity of dysphagia. It consisted of 17 items. The total scores could range between 0 and 55, with higher scores indicating worse function.
7 secondary outcomes
Murray secretion severity scale
Time frame: day 1 before any intervention, day 11, and day 60
Yale pharyngeal residue severity rating scale
Time frame: day 1 before any intervention, day 11, and day 60
Penetration-Aspiration Scale
Time frame: day 1 before any intervention, day 11, and day 60
Generalized Anxiety Disorder 7-item scale
Time frame: day 1 before any intervention, day 11, and day 60
Movement distances of the hyoid bone
Time frame: day 1 before any intervention, day 11, and day 60
Vertebral artery cerebral blood flow velocity
Time frame: day 1 before any intervention, day 11, and day 60
Vertebral artery internal diameter
Time frame: day 1 before any intervention, day 11, and day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 41782152Zeng H, Zhang W, Yang Y, Li Y, Wang S, Fang L, Wen C, Zhao W, Li D, Luo S, Zeng J, Wang X, Luo P, Li H, Wang L, Wang C, Zeng X. Effects of ultrasound-guided stellate ganglion block in poststroke bulbar palsy: a double-blind placebo-controlled trial. BMC Med. 2026 Mar 4;24(1):225. doi: 10.1186/s12916-026-04684-4.
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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 study chair
Site Coordinator of United Medical Group
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive rehabilitation, Stellate ganglion block and Lidocaine Hydrochloride in people with Bulbar Palsy, run by Zeng Xi at 6 sites 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 8 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: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modified Barium Swallow Impairment Profile (time frame: day 1 before any intervention, day 11, and day 60). 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 NCT06319534, which also lists 1 linked publication.
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 8 May 2026.