An interventional study of Dexamethasone in Bell Palsy, sponsored by Hillel Yaffe Medical Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-25.
Sponsored by Hillel Yaffe Medical Center · Not applicable, Interventional, and Treatment
Bell's palsy is defined as a facial nerve palsy without any other known cause. The common practice for this disease consists of the use of oral steroids. Such treatment can cause harm to people who have disabilities or prior conditions such as pregnancies, diabetes, obesity and/or high blood pressure. While the use of intratympanic injection for sudden sensory hearing loss is well rehearsed in many practices, similar management of facial nerve palsy due to Bell's phenomenon is rare and a few researches have been conducted regarding the subject. In this research we suggest intratympanic injections for these patients as a treatment for Bell's palsy.
Bell's palsy is defined as a facial nerve paralysis without any other known diagnosis or cause .Its' estimated occurrence is in 20 to 30 people per 100,000 people per year. The occurence is greater in patients older than 65 years old and lower in children younger than 13 years old. There are many estimated etiologies for Bell's palsy, such as failure of the vasa nervosa, viral infections, ischemic neuropathies and auto immune reactions. Of those, viral hypothesis is the most widely accepted.
The prognosis for recovery for most patients is 80% to 90%. One series showed that only 17 out of 1505 patients demonstrated moderate to severe sequela and none had complete facial nerve paralysis. The common practice for the management of Bell's palsy consists of oral steroids with or without the antiviral medications. A recent study made by the Department of Otorhinolaryngology and Head and Neck surgery in Korea indicated that Intratympanic injections could replace the use of oral steroids . Another recent study by Jong job lee et al. has shown that Intratympanic injections have prolonged uptake in rats, in comparison to Intraperitoneal injections.
85 studies on the registry are indexed under Bell Palsy; 30 are open to participants now.
This study's planned enrollment of 30 is below the median of 42 across 70 interventional studies indexed under Bell Palsy.
Browse Bell Palsy studies →Hillel Yaffe Medical Center is the lead sponsor of 305 studies on the registry; 10 are open to participants now.
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Adult patients 18 years old or more, diagnosed with Bell's palsy who cannot receive oral treatment for their condition, due to to pregnancy, diabetes, high blood pressure etc.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Steroids injection
Drug: Dexamethasone
Solution for otic injection
House brackman scale
grade 1-6
Time frame: change in score 1 month, 3 months and 6 months after end of treatment
Nottingham scale for facial palsy
ratio (distance between point in the face in cm)
Time frame: change in score 1 month, 3 months and 6 months after end of treatment
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Feb 2018; primary completion for Jan 2019, 11 months later.
Of 38 non-industry interventional studies with no phase under Bell Palsy, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 25. This study's planned 11 months is above that.
Counting every sponsor, half of 40 studies reached it within 10 months; a quarter within 3 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone