Evaluation of the response of the target muscle to direct electrostimulation and/or electrostimulation of the innervating portion of the facial nerve in patients suffering from facial palsy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015015

Enrollment

Registered

2018-06-28

Start date

2018-04-24

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G51.0

Interventions

Group 1: Intra-operative low voltage electrical stimulation directly delivered on the exposed portions of the facial nerve or directly on the exposed muscles innervated by the facial nerve. The stimul

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age = 18 - Suffering from facial palsy, including facial paresis, paralysis and synkinetic - For intra-operative stimulation only: Pre-scheduled for an ENT surgery for which portions of the facial nerve and/or muscles innervated by the facial nerve are exposed - Anatomic, physiological and mental conditions compatible with the participation in this clinical investigation - High motivation with realistic expectations regarding the participation in this clinical investigation - Signed and dated informed consent before the start of any study specific assessment.

Exclusion criteria

Exclusion criteria: - Lack of compliance with any inclusion criteria - Pregnant or breast-feeding women - Other clinical diseases that might result in alteration of the outcomes of this clinical investigation, in particular muscular diseases - Use of an active implant - Known allergies or intolerance to the material used for this clinical investigation - Current participation in other drugs and/or medical device studies that can affect the results of the present clinical investigation - Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this clinical investigation.

Design outcomes

Primary

Measure	Time frame
- The target of the stimulation (nerve vs. muscle) - The specificity of the response of the various facial muscle depending on their facial palsy grade - The stimulation setting (on awaken vs. anesthetized patients)	—

Secondary

Measure	Time frame
- Facial palsy etiology - Facial palsy duration - Age and gender of the patients	—

Countries

Germany

Contacts

Public ContactOrlando Guntinas-Lichius

Klinik und Poliklinik für Hals-, Nasen- und OhrenheilkundeInstitut für Phoniatrie und Pädaudiologie Universitätsklinikum Jena

Orlando.Guntinas@med.uni-jena.de03641 9 329301

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026