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

N/AEnrolling By InvitationNCT07070817

houyajing70 enrolled

Overview

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.

Interventions

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

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria:① Aged 18-80 years; ② Cerebral magnetic resonance imaging or computed tomography confirms medullary lesions (hemorrhage, ischemia, or tumor); ③ Dysphagia is clearly diagnosed by flexible endoscopic evaluation of swallowing (FEES); ④ Presence of sialorrhea, which is defined as meeting any one of the following three criteria: total score of the Drooling Severity and Frequency Scale (DSFS-T) ≥ 4 points, each item score of the Drooling Severity and Frequency Scale (DSFS) ≥ 2 points, or score of the Murray Secretion Scale (MSS) for pharyngeal secretions ≥ 2 points; ⑤ Conscious and able to cooperate with sialorrhea assessment and follow-up; ⑥ Willing to receive BTX-A injection, informed of the study details, and sign the relevant informed consent documents. \- Exclusion Criteria:① Having received BTX-A injection treatment in the recent six months; * 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.

Outcomes

Primary Outcomes

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

Time frame: 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

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

A flexible laryngoscope is inserted through one nostril to observe the retention of secretions in the vallecula epiglottica, piriform fossa, and laryngeal vestibule, and the MSS is used for scoring. The scoring criteria are as follows: 0 points: No secretions in the vallecula epiglottica and piriform fossa 1. point: A small amount of secretions in the vallecula epiglottica and piriform fossa 2. points: Temporary accumulation of secretions in the laryngeal vestibule 3. points: Persistent accumulation of secretions in the laryngeal vestibule

Time frame: 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)

Drooling Severity Scale (DSFS-S): The score ranges from 1 to 5, with 1 point indicating normal; 2 points indicating mild (only the lips are moist); 3 points indicating moderate (the mouth and chin are moist); 4 points indicating severe (clothes are damp); 5 points indicating persistent drooling (clothes, hands and surrounding objects are moist). Drooling Frequency Scale (DSFS-F): The score ranges from 1 to 5, with 1 point indicating no drooling; 2 points indicating occasional drooling (not every day); 3 points indicating frequent drooling (some time every day); 4 points indicating constant drooling. The total score of the overall scale is the sum of the scores of the two subscales, ranging from 2 to 9 points. A score of 2 indicates no drooling, and a score of 9 indicates severe drooling. A higher score suggests a more severe degree of drooling.

Time frame: 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

All items are evaluated using a 5-level scoring method with scores ranging from 0 to 4: 0 points indicate no symptoms; 1 point indicates mild symptoms; 2 points indicate moderate symptoms; 3 points indicate severe symptoms; 4 points indicate extremely severe symptoms. A total score of \<7 points indicates no anxiety, 7-13 points indicates possible anxiety, 14-20 points indicates anxiety, 21-28 points indicates obvious anxiety, and ≥29 points indicates severe anxiety. Among them, a score of ≥14 points suggests that the evaluated person has clinically significant anxiety symptoms.

Time frame: 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

Most items are evaluated using a 5-level scoring method with scores ranging from 0 to 4 (0 points indicate no symptoms; 1 point indicates mild symptoms; 2 points indicate moderate symptoms; 3 points indicate severe symptoms; 4 points indicate extremely severe symptoms); a few items are evaluated using a 3-level scoring method with scores ranging from 0 to 2 (0 points indicate no symptoms; 1 point indicates mild to moderate symptoms; 2 points indicate severe symptoms). A total score of \<8 points indicates no depression, 8-19 points indicates possible depression, 20-34 points indicates mild or moderate depression, and ≥35 points indicates severe depression. Among them, a score of ≥20 points suggests that the patient has clinically significant depressive symptoms.

Time frame: 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

It is judged according to the diagnostic criteria for stroke-associated pneumonia, that is, chest imaging examination reveals new or progressive pulmonary infiltrative lesions, accompanied by more than 2 clinical infection symptoms (such as fever \> 38℃; new onset of cough and expectoration or aggravation of original respiratory disease symptoms, with dyspnea or tachypnea, respiratory rate \> 25 times/min; signs of pulmonary consolidation and/or rales; peripheral blood leukocytes \> 10.0×10⁹/L or \< 4.0×10⁹/L, excluding interstitial lung changes, pulmonary edema, atelectasis, and pulmonary embolism); or age ≥ 70 years old with altered consciousness for no other clear reasons.

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

The main indicators include prealbumin, serum albumin (Alb), and hemoglobin (Hb).

Time frame: The improvement of nutritional status in the two groups of patients will be compared before BTX-A treatment and 2 weeks after treatment.