Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy : Neurotomy to Treat 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:Clinical evaluation with Sunnybrook facial grading scale, blinded to observer from video recordings at the end of the studyNeurophysiological measurements,Quality of life, measured with validated questionnaires FaCE, FDI, SAQReports of potential side effects, using Clavien-Dindo classification as well as free text.
Medienart: |
Klinische Studie |
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Erscheinungsjahr: |
2023 |
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Erschienen: |
2023 |
Enthalten in: |
ClinicalTrials.gov - (2023) vom: 06. Okt. Zur Gesamtaufnahme - year:2023 |
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Sprache: |
Englisch |
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Links: |
Volltext [kostenfrei] |
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Themen: |
610 |
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Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: January 13, 2022, Last downloaded: ClinicalTrials.gov processed this data on October 11, 2023, Last updated: October 11, 2023 |
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Study ID: |
NCT05191719 |
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Veröffentlichungen zur Studie: |
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fisyears: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
CTG008132682 |
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520 | |a 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 studyNeurophysiological measurements,Quality of life, measured with validated questionnaires FaCE, FDI, SAQReports of potential side effects, using Clavien-Dindo classification as well as free text | ||
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