Using Botox to treat swallowing difficulties caused by muscle dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy of Onabotulinum Toxin A (Botox) injections in treating transfer dysphagia, particularly in patients with neurological conditions such as stroke and multiple sclerosis. The study aims to address the dysfunction of the cricopharyngeus muscle, which can lead to significant swallowing difficulties. Participants will undergo a series of assessments, including video fluoroscopy and esophageal manometry, to evaluate their swallowing function before and after the treatment. The trial seeks to provide randomized controlled evidence on the safety and effectiveness of this intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients attending neurology OPD with swallowing dysfunction due to central nervous system dysfunction
* At least 14 years of age of all sexes
* mRS (modified Rankin scale) of ≤3 at time of study enrolment
* In case of post stroke dysphagia, at least 6 months have passed following stroke
* Willing to undergo swallowing assessment clinically and with video fluoroscopy, flexible upper GI endoscopy and esophageal manometry before and after the injection
* Above investigations show impaired cricopharyngeal relaxation, adequate pharyngeal strength and anterocephalad laryngeal movement
* Ready to provide consent for Botulinum neurotoxin injection.
* Willing to adhere to protocol and comply with follow up visits
* No major neurologic or systemic medical condition that reduces life expectancy to less than 1 year based on clinical prediction scores

Exclusion Criteria:

* Diagnosed cases of neuromuscular disorders of the peripheral nervous system and ALS
* mRS at time of enrolment \>3
* Patients with expected life expectancy less than 1 year due to primary disease or co morbidity based on clinical prediction scores
* Known allergy to botulinum neurotoxin or its preservatives/excipients
* Received botulinum toxin for any indication in the last 12 weeks
* Those with known antibodies against Botulinum neurotoxin A
* Those who underwent myotomy of the cricopharyngeus muscle
* Those who had undergone procedures like denervation of the cervical musculature
* Dysphagia of other causes not fulfilling inclusion criteria
* Women of childbearing potential who are not using adequate contraception or who are pregnant and lactating
* Not willing to provide consent

Where it's running

• All India Institute of Medical Sciences, New Delhi
  New Delhi, National Capital Territory of Delhi, India Recruiting

Study contacts

• Principal investigator: Arunmozhimaran Elavarasi, MD DM — All India Institute of Medical Sciences
• Study coordinator: Arunmozhimaran Elavarasi, MD DM
• Email: arun_ela@yahoo.com
• Phone: +919013844274

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.