Status:
UNKNOWN
Onabotulinum Toxin A (Botox) in the Treatment of Transfer Dysphagia
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Transfer Dysphagia
Oropharyngeal Dysphagia
Eligibility:
All Genders
14+ years
Phase:
PHASE2
PHASE3
Brief 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 relax...
Detailed Description
Swallowing is a neurologically coordinated physiologic event that requires sequential and overlapping movements of various craniofacial, pharyngo-esophageal and laryngeal muscles. In the process of sw...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04695600
Start Date
August 22 2023
End Date
December 31 2023
Last Update
September 13 2023
Active Locations (1)
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1
All India Institute of Medical Sciences, New Delhi
New Delhi, National Capital Territory of Delhi, India, 110029