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

Launched by HOUYAJING · Jul 8, 2025

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ClinConnect Summary

This study is testing whether ultrasound-guided injections of botulinum toxin type A (BTX-A) into the salivary glands can help adults with true bulbar palsy (from medullary injuries) who have bothersome drooling (sialorrhea). It’s a randomized, double-blind trial, meaning you’re randomly assigned to either the BTX-A injection group or a placebo (saline) injection group, and neither you nor the researchers know which one you received. All participants also receive the same swallowing rehabilitation therapy. The goal is to see if reducing saliva production with BTX-A can improve drooling and related swallowing problems.

Who can be eligible? Adults aged 18–80 with medullary lesions confirmed by brain imaging, diagnosed swallowing problems, and drooling defined by specific scoring criteria. Exclusions include recent BTX-A treatment, allergy to botulinum toxin, certain medications or serious illnesses, infection at the injection site, or being on anticoagulants. If enrolled, you’ll undergo an ultrasound-guided injection into the parotid and submandibular glands (about 100 units of BTX-A) or a placebo, then continue the same swallowing rehab. You’ll have follow-up assessments at about 1, 2, and 4 weeks after treatment to measure drooling, swallowing function, mood, infection risk, and nutritional status. The study is currently enrolling in Beijing, China, and results are not yet available.

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Eligibility criteria

• • 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.
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• • 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.