Trials / Unknown
UnknownNCT05191719
Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 73 (estimated)
- Sponsor
- Rebecka Ohm · Academic / Other
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate neurotomy as an alternative treatment to Botox injections for severe synkinesis following peripheral facial palsy
Detailed 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Botox injection | Comparator, current gold standard |
| PROCEDURE | Neurotomy | Surgical procedure |
Timeline
- Start date
- 2022-02-01
- Primary completion
- 2026-02-01
- Completion
- 2026-02-01
- First posted
- 2022-01-13
- Last updated
- 2023-10-06
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT05191719. Inclusion in this directory is not an endorsement.