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The effect of BOTOX on cricopharyngeal dysfunction in patient with stroke guided by combination of catheter balloon, ultrasound and electromyography: a randomized, double-blinded, placebo-controlled trial

The effect of BOTOX on cricopharyngeal dysfunction in patient with stroke guided by combination of catheter balloon, ultrasound and electromyography: a randomized, double-blinded, placebo-controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025562
Enrollment
Unknown
Registered
2019-09-01
Start date
2019-09-09
Completion date
Unknown
Last updated
2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cricopharyngeal dysfunction

Interventions

BOTOX group:BOTOX injection
control group:Normal saline

Sponsors

The Third Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Men and women meeting the diagnostic criteria of stroke listed in the 4th national cerebrovascular academic conference; 2) stable vital signs without severe cardiopulmonary disease; 3) aged 18~90 years; 4) no significant improvement in swallowing function after 1 week of balloon dilation; 5) functional oral intake scale (FOIS) 20mmHg; 8) good cooperation; 9) signed the informed consent.

Exclusion criteria

Exclusion criteria: 1) patient with other neurogenic dysphagia or disease which can cause dysphagia; 2) patient with non-neurogenic dysphagia (e.g. cancer); 3) patient with neurogenic disease (e.g. myasthenia gravis, motor neuron disease); 4) patient with progressive psychopathy; 5) patient can't cooperate examination and treatment; 6) infections and cuts at injection site; 7) patient allergic to botulinum toxin; 8) patient with coagulation dysfunction; 9) patient used the medicine worked on the neuromuscular junction or anesthetics within 1 month; 10) patient joined other study which could influence the results of the injection of botulinum toxin on cricopharyngeal muscle.

Design outcomes

Primary

MeasureTime frame
Functional Oral Intake Scale (FOIS);

Secondary

MeasureTime frame
relaxation residual pressure of UES;resting pressure of UES;relaxation duration of UES;velopharyngeal and laryngopharyngeal peak pressure;Degree, range and time of cyclopharyngeal muscle opening;pharyngeal construction ratio;Residual in epiglottis valley or piriform sinus;penetration and aspiration;

Countries

China

Contacts

Public ContactWen Hongmei

The Third Affiliated Hospital of Sun Yat-Sen University

wenhm0625@126.com+86 13570093589

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026