RecruitingPhase 2Phase 3NCT04695600

Onabotulinum Toxin A (Botox) in the Treatment of Pharyngo-esophageal Dysphagia

Efficacy and Safety of Onabotulinum Toxin A (Botox) Injections in the Upper Esophageal Sphincter for the Treatment of Pharyngo-esophageal Dysphagia Due to Cricopharyngeal Dysfunction- A Randomized Double Blinded Placebo Controlled Trial

Sponsor

All India Institute of Medical Sciences

Enrollment

100 participants

Start Date

Aug 11, 2023

Study Type

INTERVENTIONAL

Conditions

Oropharyngeal Dysphagia Transfer Dysphagia Cricopharyngeus Muscle Dysfunction

Summary

Dysphagia in patients with stroke, multiple sclerosis, parkinsonism or dystonia can occur due to relative hypertonia of the cricopharyngeus muscle. In the resting state, muscle is contracted and relaxes only during deglutition. Treatment of dysphagia by injecting botulinum toxin in the cricopharyngeus was described by Schneider et al. in 1994. More than 100 cases have been described after that, however there are no randomized controlled trials. A meta-analysis from Cochrane has also concluded that there is no sufficient evidence to conclude regarding the efficacy and safety of Botulinum toxin injection in cricopharyngeal dysfunction. So this study is necessary to fill this void in knowledge

Eligibility

Min Age: 14 Years

Inclusion Criteria11

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
Women of childbearing potential who are not using adequate contraception or who are pregnant and lactating
Not willing to provide consent

Exclusion Criteria8

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