Post-examination of patients with facial nerve palsy in childhood
Organizational Data
- DRKS-ID:
- DRKS00033340
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2024-01-09
- Last update in DRKS:
- 2024-01-09
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
Patients who suffered from facial nerve palsy in childhood are not administered steroids as they are believed to recover completely on their own. However, various studies indicate that asymmetries or synkinesia may develop in these patients and that full recovery does not occur. The aim of this study is to investigate how well patients with pediatric facial nerve palsy really recover, whether there is permanent damage that has been overlooked by the pediatricians treating them and whether treatment with prednisolone should therefore be discussed more as a treatment option for children.
Health condition or problem studied
- Free text:
- peripheral facial paralysis
- ICD10:
- G51.0 - Bell palsy
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- Patients who developed peripheral facial nerve palsy before the age of 18 A video meeting is arranged in which the patients are asked to perform certain facial movements (raise eyebrows, wrinkle nose, purse lips, etc.). This video is subsequently evaluated by the study leader and a second rater for asymmetries and synkinesia. In the course of the video consultation, the patient is also asked to complete 5 questionnaires that deal more generally and specifically with facial nerve palsy and its progression. The questionnaires have been added under the last point of the registration form
Endpoints
- Primary outcome:
- The aim of this study is to find out whether pediatric facial nerve palsy regresses completely and without side effects or whether any effects that may occur, such as asymmetries in the face or synkinesia, have so far been overlooked. This is determined by evaluating the questionnaires and by analyzing the video recordings via eFaCE and Sunnybrook.
- Secondary outcome:
- The secondary objective is to determine whether asymmetries or side effects occurred less frequently during early treatment with prednisolone and whether it can be concluded from this that this therapy is also effective in children. The patients are first differentiated according to whether they received prednisolone as therapy or not. These groups are then compared with each other in order to determine any differences in the outcome of the patients.
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- Retrospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Cross-sectional study
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsklinikum Jena Jena
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2023-12-16
- Planned study completion date:
- 2024-07-01
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 50
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - Facial nerve palsy diagnosed by a doctor and treated at Jena University Hospital Patients who developed facial nerve palsy before the age of 18 - Written consent of the patient or legal guardian (for patients under the age of 18) to participate in the study
Exclusion Criteria
- Lack of written consent from adult patients or legal guardians to perform the examination - Patients who were at least 18 years old when the facial nerve palsy occurred
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum, Klinik und Poliklinik für Hals-. Nasen- und OhrenheilkundePD Dr. Gerd Fabian Volk07747 JenaGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Jena, Klinik und Poliklinik für Hals-. Nasen- und OhrenheilkundePD Dr. Gerd Fabian VolkAm Klinikum 107747 JenaGermany
- Telephone:
- 03641-9-329301
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsklinikum Jena, Klinik und Poliklinik für Hals-. Nasen- und OhrenheilkundePD Dr. Gerd Fabian VolkAm Klinikum 107747 JenaGermany
- Telephone:
- 03641-9-329301
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum Jena, Klinik und Poliklinik für Hals-. Nasen- und OhrenheilkundePD Dr. Gerd Fabian VolkAm Klinikum 107747 JenaGermany
- Telephone:
- 03641-9-329301
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum Jena, Klinik und Poliklinik für Hals-. Nasen- und Ohrenheilkunde07747 JenaGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Friedrich-Schiller-Universität Jena an der Medizinischen FakultätBachstr. 1807740 JenaGermany
- Telephone:
- +49-3641-9391191
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinikum-jena.de/ethikkommission/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-03-17
- Ethics committee number:
- 2023-2993_1-BO
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-05-12
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Studienprotokoll
- Study abstract:
- No Entry
- Other study documents:
- Patientenanschreiben per Post
- auszufüllende Einverständniserklärung für Patienten
- Fragebögen
- Patientenaufklärung und Einwilligungserklärung
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- Juni 2025
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry