Feasibility Study for Clinical Trial for Electric Stimulation in Idiopathic Facial Paralysis with Poor prognosis
Myriam D Loyo, MD1; Michelle U Cameron, MD, PT2; Inaki Martinez-Creel, BA1
1Oregon Health and Science University, Portland, OR, 2Portland Vetereans Administration Hospital, Portland, OR
Background: Idiopathic facial palsy is the most common form of facial paralysis with an incidence of 1 in 60 people in a lifetime. Although most patients are expected to recover, up to 29% of patients experience life-long residual muscle weakness, involuntary contractions, spasms and unintentional movements that occur simultaneous with intentional movement (synkinesis). Electrical stimulation of the face could potentially reduce these sequelae. Five published clinical trials have examined electrical stimulation of the face during acute Bell's palsy. Two trials reported mild benefit from electrical therapy (Tuncay et al. 2015 and Manikandan et al. 2006), while the remainder showed no difference in recovery. Worse recovery with electrical stimulation has not been reported. Given limitations of prior trial design, the effect of electrical stimulation could be underestimated. There is a need to further understand the effect of electrical stimulation for patients with facial paralysis.
Material and Methodology: The goal of the study is to do a feasibility trial for patients with acute (<1 month) idiopathic paralysis with poor prognostic factors to be randomized to transcutaneous electrical stimulation versus placebo. The study is double-blinded. All patients will receive standard of care steroid treatment. Poor prognosis will de defined as either: complete paralysis or age greater than 60 years. The stimulation settings would be monophasic waveform having 100 msec pulse duration, 300 msec interpulse interval, and a pulse rate 2.5 pulses/second. Patients with deep brain stimulators, pacemakers, and/or tape allergies would be excluded. The primary outcome measure will be complete recovery at 1, 2 and 3- month follow up times as judged by clinical experts based on photographs by the eFACES scale. Secondary outcome measures will be patient-reported outcomes, objective facial movement and symmetry, and patient tolerability and side effects.
Results: Following 6 months of recruitment, 8 patients have been eligible for the study and 4 patients have been recruited. Difficulty with travel to the hospital made 3 patients decline participation. Modifications have been made to offer telemedicine alternatives. At the time of the ASPN annual meeting 6 more months of recruitment will have taken place. We will break the blind and analyze our results then.
Discussion and conclusion: pending
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