NCT06225076

Brief 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. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 20-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

January 30, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

January 13, 2024

Last Update Submit

March 2, 2024

Conditions

Bulbar Palsy

Outcome Measures

Primary Outcomes (1)

  • Penetration-Aspiration Scale

    On the day 1 and day 20, 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.

    day 1 and day 20

Secondary Outcomes (4)

  • Functional Oral Intake Scale

    day 1 and day 20

  • Video Fluoroscopic Swallowing Study

    day 1 and day 20

  • Murray secretion severity scale

    day 1 and day 20

  • Yale pharyngeal residue severity rating scale

    day 1 and day 20

Study Arms (2)

The observation group

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 20 days.

Behavioral: Comprehensive rehabilitationProcedure: Stellate ganglion blockDrug: Lidocaine Hydrochloride

The control group

ACTIVE 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 20 days.

Behavioral: Comprehensive rehabilitation

Interventions

Comprehensive rehabilitationBEHAVIORAL

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.). Regrading swallowing function training, both groups are 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, 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.

The control groupThe observation group
Stellate ganglion blockPROCEDURE

the patients in the observation group were provided with Stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). 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 observation group
Lidocaine HydrochlorideDRUG

the patients in the observation group were provided with Stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). 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.

Also known as: Injection
The observation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
  • Upper Esophageal Sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by Videofluoroscopic Swallow Study.
  • Age \>18 years.
  • First-time stroke.
  • Steady vital signs,
  • Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset.

You may not qualify if:

  • The bulbar palsy caused by other diseases, such as neurodegenerative diseases.
  • Pseudobulbar palsy.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zheng Da First Hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Bulbar Palsy, Progressive

Interventions

LidocaineInjections

Condition Hierarchy (Ancestors)

Motor Neuron DiseaseNeurodegenerative DiseasesNervous System DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Nieto Luis, Master

    Site Coordinator of United Medical Group located in Miami

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

January 13, 2024

First Posted

January 25, 2024

Study Start

January 30, 2024

Primary Completion

April 15, 2024

Study Completion

May 30, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)