An interventional study of Botox injection and Neurotomy in Facial Paralysis, Facial Palsy and Peripheral Facial Palsy, sponsored by Rebecka Ohm. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by Rebecka Ohm · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate neurotomy as an alternative treatment to Botox injections for severe synkinesis following peripheral facial palsy
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:
81 studies on the registry are indexed under Facial Paralysis; 28 are open to participants now.
This study's planned enrollment of 73 is above the median of 50 across 59 interventional studies indexed under Facial Paralysis.
Browse Facial Paralysis studies →This is the only study on the registry with Rebecka Ohm as lead sponsor.
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Exclusion Criteria:
Procedure: Botox injection · Procedure: Neurotomy
Procedure: Botox injection · Procedure: Neurotomy
Comparator, current gold standard
Surgical procedure
Sunnybrook facial grading scale
Improvement through less synkinesis and better voluntary movement
Time frame: Baseline, 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Quality of life questionnaire
Facial Clinimetric Evaluation Scale (FaCE)
Time frame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Quality of life questionnaire
Facial Disability Index (FDI)
Time frame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Quality of life questionnaire
Synkinesis Assessment Questionnaire (SAQ)
Time frame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Neurophysiological examination, electromyography (EMG).
Severity of synkinesis evaluation using EMG calculations (turns and root mean square (RMS)) compared to the healthy hemiface (reference).
Time frame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), just before surgery, 6 and 12 months after surgery
Number of Botox injections
Decrease to no future need
Time frame: Baseline, 12 months after surgery
Side effects
Clavien-Dindo Classification
Time frame: Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Side effects
Free text, in order to capture all possible side effects of treatments.
Time frame: Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
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