A Clinical Study of Ultrasound-guided Botulinum Toxin A Into Salivary Gland for Sialorrhea After True Bulbar Palsy

NCT07070817 | Enrolling By Invitation DMC

• 1 other identifier: 2024FXHEC-KSP017
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Sialorrhea refers to a group of syndromes characterized by excessive saliva secretion from the salivary glands or reduced clearance of oral saliva due to dysphagia, resulting in saliva overflowing from the corners of the mouth or accumulating in the pharynx. It is one of the common clinical problems in conditions such as cerebral palsy, Parkinson's disease \[1\], and brain injuries (including stroke, traumatic brain injury, and hypoxic-ischemic encephalopathy). Among them, true bulbar palsy after medullary injury often causes saliva to flow out from the corners of the mouth due to sensory impairment in the oral cavity, tongue, and pharynx, as well as motor dysfunction and loss of coordination of swallowing-related muscles \[2\]; on the other hand, it often leads to residual saliva in the hypopharynx due to weakness of the pharyngeal constrictor muscles and dysfunction of the upper esophageal sphincter \[3\]. Sialorrhea can not only cause oral odor, skin breakdown, and malnutrition but also have a negative impact on patients' psychology, and even lead to choking or aspiration pneumonia, seriously endangering their physical and mental health. Therefore, active management and treatment of sialorrhea in patients with true bulbar palsy have become the key to solving this problem. Currently, the management of sialorrhea mainly involves improving swallowing function to enhance saliva clearance and using drug intervention to reduce saliva secretion, thereby alleviating sialorrhea symptoms. However, current studies have found that swallowing function cannot recover quickly in a short time in patients with medullary injury. Therefore, active intervention is needed to reduce saliva secretion to relieve sialorrhea symptoms. Clinical treatments for sialorrhea include drug therapy, botulinum toxin therapy, radiation therapy, and surgical treatment. Among them, oral drug therapy is mainly based on antimuscarinic drugs. Although it has a certain therapeutic effect, its clinical application is limited due to the side effects of systemic anticholinergic effects; while surgical treatment is not clinically adopted because of its high destructiveness. In recent years, a number of clinical studies on botulinum toxin type A (BTX-A) in the treatment of sialorrhea in adults (Parkinson's disease, traumatic brain injury) and children (cerebral palsy) have been carried out at home and abroad, and its efficacy and safety have been verified \[4\] \[5\]. However, there are few reports on BTX-A in the treatment of sialorrhea in patients with medullary lesions. Therefore, this study aims to conduct a randomized controlled trial to explore the effect of ultrasound-guided botulinum toxin type A injection into the salivary glands on sialorrhea in patients with true bulbar palsy, and comprehensively evaluate the efficacy and safety of BTX-A in the treatment of sialorrhea by combining subjective scale assessment and objective instrument assessment.

Conditions

Sialorrhea True Bulbar Palsy Medullary Injury

Outcome Measures

Primary Outcomes (1)

• Global Impression of Change Scale (GICS) assessment:

  This scale rates the patient's current condition by comparing it with the initial condition, with scores ranging from 0 to 7. The specific criteria are as follows: This scale rates the patient's current condition by comparing it with the initial condition, with scores ranging from 0 to 7. The specific criteria are as follows: 0 points: Not evaluated 1. point: Significant improvement 2. points: Improvement 3. points: Slight improvement 4. points: No change 5. points: Slight deterioration 6. points: Deterioration 7. points: Severe deterioration

  The Global Impression of Change Scale (GICS) will be used to assess symptoms at 1 week, 2 weeks, and 4 weeks after injection treatment.

Secondary Outcomes (6)

• Flexible Endoscopic Evaluation of Swallowing (FEES) combined with Murray Secretion Scale (MSS) assessment:

  Murray Secretion Scale (MSS) will be used to assess the patients' sialorrhea symptoms before BTX-A treatment, as well as 1 week, 2 weeks, and 4 weeks after treatment, respectively.

• Assessment with Drooling Severity and Frequency Scale (DSFS)

  The Drooling Severity Scale (DSFS-S), Drooling Frequency Scale (DSFS-F) will be used to assess the patients' sialorrhea symptoms before BTX-A treatment, as well as 1 week, 2 weeks, and 4 weeks after treatment, respectively.

• Assessment with Hamilton Anxiety Scale

  The incidence of depression in the two groups of patients will be compared before BTX-A treatment and2weeks and 4 weeks a after treatment.

• Assessment with Hamilton Depression Scale

  The incidence of Anxiety in the two groups of patients will be compared before BTX-A treatment and 2weeks and 4 weeks after treatment.

• Occurrence of Pulmonary Infection

  The incidence of stroke-associated pneumonia in the two groups of patients will be compared before BTX-A treatment and 2 weeks after treatment.

Study Arms (2)

Ultrasound-Guided Botulinum Toxin Type A (BoNT-A) Salivary Gland Injection Group

EXPERIMENTAL

Experimental Arm (Group B) Intervention: Participants receive ultrasound-guided A 100IU (BTX-A) injection into the salivary glands combined with the same routine swallowing rehabilitation training as the control arm. Details of BTX-A injection: BTX-A is diluted with 2 mL of 0.9% NaCl. Injections are administered under ultrasound guidance, targeting the parotid and submandibular glands (specific dosage and injection sites follow clinical standards). Rehabilitation training: Identical in content, frequency, and duration to the control arm, ensuring that any differences in outcomes can be attributed to the BTX-A injection.

Drug: Ultrasound-Guided Botulinum Toxin Type A (BoNT-A) Salivary Gland Injection

Ultrasound-Guided Saline (Placebo) Salivary Gland Injection Group

PLACEBO COMPARATOR

Description: This arm includes participants with true bulbar palsy and sialorrhea who will receive ultrasound-guided injections of a placebo (sterile saline) into the salivary glands. It serves as a control to compare against the active intervention arm.

Drug: Control (Normal saline)

Interventions

Ultrasound-Guided Botulinum Toxin Type A (BoNT-A) Salivary Gland Injection DRUG

Ultrasound-guided injection of BoNT-A (specific dosage, e.g., "100 units") into target salivary glands ( parotid and submandibular glands) at baseline.

Ultrasound-Guided Botulinum Toxin Type A (BoNT-A) Salivary Gland Injection Group

Control (Normal saline) DRUG

Intervention: Participants receive routine swallowing rehabilitation training only. Details of training: The training includes standard techniques to improve swallowing function, such as oral motor training, empty swallowing exercises, and ice stimulation. The frequency and duration of training are consistent across all participants in this arm to ensure standardization.

Ultrasound-Guided Saline (Placebo) Salivary Gland Injection Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Having an allergy or contraindication to botulinum toxin;
• Having taken drugs for treating sialorrhea or drugs that can cause sialorrhea in the recent month;
• Having severe diseases of important organs such as the heart, lungs, liver, kidneys, or malignant tumors, etc.; ⑤ Concomitantly using aminoglycoside antibiotics and warfarin; ⑥ Patients with infection or skin lesions at the injection site, or severe muscle atrophy at the injection site, or those with infection at the injection site, or skin lesions at the injection site, or severe muscle atrophy at the injection site, or infection.

Sponsors & Collaborators

• houyajing: lead

Study Sites (1)

Fuxing Hospital Affiliated to Capital Medical University

Beijing, China

Location

MeSH Terms

Interventions

incobotulinumtoxinA; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Use a randomization tool to generate a random number table and set a seed number. Generate random envelopes based on the random code table. Cases that meet the inclusion and exclusion criteria will be enrolled in sequence according to the content of the random envelopes in the order of enrollment. Researchers responsible for enrolling patients will recruit patients. Those assigned to the botulinum toxin group will receive type A botulinum toxin (diluted with 2ml of 0.9% NaCl) plus routine swallowing rehabilitation training."
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Fuxing Hospital affiliated to Capital Medical University

Model Details: This is a randomized, controlled, double-blind interventional study designed to evaluate the efficacy and safety of ultrasound-guided botulinum toxin type A (BTX-A) injection into salivary glands for treating sialorrhea in patients with true bulbar palsy. The study adopts a parallel-group design with a 1:1 allocation ratio between the experimental group and the control group, following strict randomization and blinding procedures to ensure the objectivity and reliability of results. 1.Study Design Type A randomized controlled trial (RCT) with a parallel-group design, comparing two intervention strategies: 1.1Control group (Group A): Routine swallowing rehabilitation training. 1.2Experimental group (Group B): Ultrasound-guided BTX-A injection into the parotid and submandibular glands, combined with the same routine swallowing rehabilitation training as the control group.

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: June 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)