Onabotulinum Toxin A (Botox) in the Treatment of Transfer Dysphagia

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

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