Using Botox to treat swallowing difficulties caused by muscle dysfunction
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
This study is testing if Botox injections can help people with swallowing problems caused by muscle issues related to conditions like stroke and multiple sclerosis.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences, New Delhi Academic / other |
| Locations | 1 site (New Delhi, Delhi) |
| Trial ID | NCT04695600 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of Onabotulinum Toxin A (Botox) injections in treating transfer dysphagia, particularly in patients with neurological conditions such as stroke and multiple sclerosis. The study aims to address the dysfunction of the cricopharyngeus muscle, which can lead to significant swallowing difficulties. Participants will undergo a series of assessments, including video fluoroscopy and esophageal manometry, to evaluate their swallowing function before and after the treatment. The trial seeks to provide randomized controlled evidence on the safety and effectiveness of this intervention.
Who should consider this trial
Good fit: Ideal candidates include patients aged 14 and older with swallowing dysfunction due to central nervous system issues and a modified Rankin scale score of 3 or less.
Not a fit: Patients with diagnosed neuromuscular disorders of the peripheral nervous system or amyotrophic lateral sclerosis (ALS) may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve swallowing function and quality of life for patients suffering from dysphagia due to cricopharyngeal dysfunction.
How similar studies have performed: While there have been numerous case reports on this treatment, this study is necessary as there are currently no randomized controlled trials demonstrating its efficacy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Delhi, Delhi
- All India Institute of Medical Sciences, New Delhi — New Delhi, Delhi, India (Recruiting)
Study contacts
- Principal investigator: Arunmozhimaran Elavarasi, MD DM — All India Institute of Medical Sciences, New Delhi
- Study coordinator: Arunmozhimaran Elavarasi, MD DM
- Email: arun_ela@yahoo.com
- Phone: +919013844274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.