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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox | Active Comparator |
| |
| Neurotomy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox injection | Procedure | Comparator, current gold standard |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sunnybrook facial grading scale | Improvement through less synkinesis and better voluntary movement | Baseline, 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life questionnaire | Facial Clinimetric Evaluation Scale (FaCE) | 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery |
| Quality of life questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecka Ohm, MD, PhDStud. | Contact | +4651770000 | rebecka.ohm@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Birgit Stark, MD, PhD | Karolinska Institute/Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital/Karolinska Institute | Recruiting | Stockholm | Sweden |
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| ID | Term |
|---|---|
| D005158 | Facial Paralysis |
| D020330 | Bell Palsy |
| D046608 | Synkinesis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D003714 | Denervation |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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All study participants are evaluated with and without the effect Botox treatment before surgery. Botox is the gold standard treatment and used as a comparator. As all study patients have failed current evidence based treatment options, a comparative group not receiving treatment would imply a strong information bias.
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| Neurotomy |
| Procedure |
Surgical procedure |
|
Facial Disability Index (FDI)
| 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) | 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). | 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 | Baseline, 12 months after surgery |
| Side effects | Clavien-Dindo Classification | 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. | Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery |
| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D005155 | Facial Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D020820 | Dyskinesias |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |