The primary objective of our study is to evaluate sensation (static/moving pressure/touch, hot/cold temperature and pain threshold) of the face in patients with unilateral facial nerve palsy and compare the sensation of the affected side to the non-…
ID
Source
Brief title
Condition
- Cranial nerve disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To evaluate sensation of the face in patients with unilateral facial nerve
palsy and compare the sensation of the affected side to the non-affected side.
- To compare sensation of the face in patients with synkinesis after facial
nerve palsy to patients with hemifacial spasms due to a neurovascular conflict.
Secondary outcome
- To evaluate the change in sensation of the face at the beginning and during
recovery of facial nerve palsy.
- To measure quality of life by use of the FACE-Q Paralysis scale in patients
with unilateral facial nerve palsy.
- To investigate whether a correlation exists between sensation of the face and
course of the facial palsy in time.
Background summary
Facial nerve palsy is a peripheral nerve dysfunction causing ipsilateral facial
muscle weakness or even (temporary) loss of function. Some patients have
described changes in facial sensation during and after their facial palsy,
ranging from hyperesthesia and numbness, to altered temperature sensation or
even pain. Few studies have evaluated facial sensation during facial palsy and
the existing studies are cross-sectional and have measured only static
pressure/touch and two-point discrimination, without assessing moving touch and
hot/cold temperature. Besides influencing sensation, a facial nerve palsy can
have a significant impact on patient*s mood and quality of life (QoL).
Study objective
The primary objective of our study is to evaluate sensation (static/moving
pressure/touch, hot/cold temperature and pain threshold) of the face in
patients with unilateral facial nerve palsy and compare the sensation of the
affected side to the non-affected side. Besides, we want to compare sensation
of the face between patients with synkinesis after facial palsy and patients
with hemifacial spasms due to a neurovascular conflict
The secondary objectives of our study are to evaluate the change in sensation
of the face at the beginning and during recovery of facial nerve palsy, to
measure QoL by use of the newly developed Paralysis module of the FACE-Q, and
to investigate a possible correlation between the course of the facial palsy en
sensation of the face. Eventually, we would like to further investigate the
relationship between the (largely) motor facial nerve and the (largely)
sensible trigeminal nerve. The connection and relationship between the two
cranial nerves might play an important role in the development of synkinesis
and is therefore important to evaluate and gain more knowledge on.
Study design
A prospective cohort study conducted in the Maastricht University Medical
Centre (MUMC+).
Study burden and risks
Participation is voluntarily. Participants can withdraw at any time during the
study without further consequences. There are no direct risks associated with
participation, as the measurements for the study are non-invasive, harmless,
and not painful. Patients may experience extra follow-up visits as beneficial
and results collected during the study could potentially increase insight in
the pathophysiology of facial nerve paralysis.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Group 1 (new onset facial palsy patients):
- 18 years or older, and;
- (A history of) unilateral facial nerve palsy, independent of etiology
Group 2A/B (facial synkinesis/hemifacial spasms patients):
- 18 years or older, and;
- (A history of) unilateral facial nerve palsy, independent of etiology, and;
- >=1 year after the start of the facial nerve palsy, or;
- Hemifacial spasms caused by a neurovascular conflict
Exclusion criteria
Group 1:
- First presentation longer than 3 weeks after onset of facial nerve palsy
(relative exclusion criterium, this is not the case for patients with
synkinesis)
- Bilateral facial nerve palsy
Group 2A/B:
- (A history of) bilateral facial nerve palsy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL82725.068.22 |