Transfer DysphagiaOropharyngeal DysphagiaCricopharyngeus Muscle Dysfunction
Investigational drug(s) / intervention(s)
Botulinum Toxin Type A Injection [Botox]
Botulinum Toxin Type A Injection [Botox]: 50 units of Botulinum toxin A (Botox, Allergan, CA) under endoscopic guidance will be injected in the cricopharyngeus muscle
Study 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
Sex
ALL
Min age
14 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Proportion of patients who have moderate to significant improvement in swallowing function on self assessment and clinical swallowing assessment - 3 weeks — 3 weeks To compare the proportion of patients who have moderate to significant improvement in swallowing function on self assessment and clinical swallowing assessment at 3 weeks post injection amongst those who received onabotulinum toxin (Botox, Allergan, Irvine, CA) and those who received placebo.
Trial sites (1)
Facility
City
Region
Status
All India Institute of Medical Sciences, New Delhi
New Delhi
National Capital Territory of Delhi
Recruiting
More All India Institute of Medical Sciences trials in India
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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