Onabotulinum Toxin A (Botox) in the Treatment of Transfer Dysphagia
Transfer Dysphagia, Oropharyngeal Dysphagia, Cricopharyngeus Muscle Dysfunction
About this trial
This is an interventional treatment trial for Transfer Dysphagia focused on measuring Botulinum toxin, Cricopharyngeal dysfunction
Eligibility 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
Sites / Locations
- All India Institute of Medical Sciences, New DelhiRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Botulinum toxin arm
Placebo arm
100 units of botulinum toxin (Botox, Allergan, CA) diluted in 2.5 mL of normal saline will be injected into the cricopharyngeus muscle under direct endoscopic vision using an esophago-gastro-duodenoscope (GIF 190,Olympus). The procedure will be done under general anesthesia in the endoscopy suite as the position of the endoscope is unstable at cricopharynx and the muscle needs to be relaxed during the procedure. Pre-procedure a Ryle's tube will be placed into the stomach under endoscopic guidance which will be kept a day post procedure. Cricopharyngeus muscle will be identified as the muscle at the upper esophageal sphincter located just behind the laryngeal opening. Botulinum toxin will be injected into the muscle in four aliquots into each quadrant using 23 G needle (160cm). Post procedure patient will be observed for an hour for any untoward adverse event
2.5 mL of Normal saline will be injected into the cricopharyngeus muscle under direct endoscopic vision using an esophago-gastro-duodenoscope (GIF 190,Olympus). The procedure will be done under general anesthesia in the endoscopy suite as the position of the endoscope is unstable at cricopharynx and the muscle needs to be relaxed during the procedure. Pre-procedure a Ryle's tube will be placed into the stomach under endoscopic guidance which will be kept a day post procedure. Cricopharyngeus muscle will be identified as the muscle at the upper esophageal sphincter located just behind the laryngeal opening. Post procedure patient will be observed for an hour for any untoward adverse event