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临床试验/NCT07070817
NCT07070817撤回不适用

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

houyajing1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年12月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
70
试验地点
1
主要终点
Global Impression of Change Scale (GICS) assessment:

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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."

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

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

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.

干预措施: Control (Normal saline) (Drug)

结局指标

主要结局

Global Impression of Change Scale (GICS) assessment:

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

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

次要结局

  • 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.)
  • The main indicators include prealbumin, serum albumin (Alb), and hemoglobin (Hb).(The improvement of nutritional status in the two groups of patients will be compared before BTX-A treatment and 2 weeks after treatment.)

研究者

发起方
houyajing
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

houyajing

Fuxing Hospital affiliated to Capital Medical University

Fu Xing Hospital, Capital Medical University

研究点 (1)

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