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Clinical Trial Summary

The purpose of this study is to evaluate neurotomy as an alternative treatment to Botox injections for severe synkinesis following peripheral facial palsy

Clinical Trial Description

Patients with severe synkinesis treated at Karolinska University Hospital with Botox injections with unsatisfying results are invited to participate in this study aiming to evaluate surgical neurotomy to synkinesis causing branches of the facial nerve. Surgical procedure: Small branches of the facial nerve are identified under microscopic magnification. Using a precise nerve stimulator the movement each nerve branch elicits is evaluated as normal or synkinetic. Pathological branches are then parted while normal functioning nerve branches are left intact. Evaluation procedure: Study participants are measured in a multimodal manner at 5 different time points during the study period; at study start, with and without Botox effect before surgery, and at 6 and 12 months after surgery. Evaluation methods: - Clinical evaluation with Sunnybrook facial grading scale, blinded to observer from video recordings at the end of the study - Neurophysiological measurements, - Quality of life, measured with validated questionnaires FaCE, FDI, SAQ - Reports of potential side effects, using Clavien-Dindo classification as well as free text ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05191719
Study type Interventional
Source Karolinska University Hospital
Contact Rebecka Ohm, MD, PhDStud.
Phone +4651770000
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 2, 2022
Completion date March 2024

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