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Functional MRI Study Facial Synkinesis

Primary Purpose

Facial Synkinesis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
MRI Scan
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Facial Synkinesis focused on measuring functional MRI (fMRI), Neural plasticity, Nuclear hyperexcitability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for all participants:

  • absence of facial nerve transposition;
  • participants must be 18 years of age or older;
  • signed informed consent.

Inclusion Criteria for patients with facial synkinesis:

  • patients must have severe facial synkinesis based on the Sunnybrook facial grading system at the time the MRI scan is performed
  • synkinesis must occur only on one side of the face

Exclusion Criteria for all participants:

  • previous neurosurgery
  • contraindications for MRI investigation, such as a pacemaker, implanted pumps or stimulators, iron materials (e.g., piercings), facial tattoos and permanent make up, or claustrophobia.

Exclusion Criteria for control participants:

  • control participants must have no forms of facial paralysis prior to the MRI examination and at the time of the MRI procedure.

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients with facial synkinesis

Control participants

Arm Description

Functional MRI scan of the primary and secondary somatosensory cortexes, the primary motor cortex, the supplementary motor cortex, and the ventral lateral premotor cortex while the participant performs motor and sensory tasks.

Functional MRI scan of the primary and secondary somatosensory cortexes, the primary motor cortex, the supplementary motor cortex, and the ventral lateral premotor cortex while the participant performs motor and sensory tasks.

Outcomes

Primary Outcome Measures

The neuroplasticity of the brain after facial synkinesis will be measured using functional MRI
Changes in the blood oxygen level dependent (BOLD) contrast as a function of motor and sensory tasks of the face will be measured using fMRI.
hyperexcitability of the pons as a result of synkinesis will be measured using functional MRI
hyperexcitability of the pons as a result of oral-ocular facial synkinesis compared to the contralateral side or healthy control participants will be measured using fMRI.

Secondary Outcome Measures

Differences in the somatotopy of the sensory area between patients with oral-ocular facial synkinesis compared to healthy control participants will be mapped using functional MRI.
Differences between groups in somatotopy of the face in the somatosensory cortex will be assessed using fMRI.
Differences in the somatotopy of the motor area between patients with oral-ocular facial synkinesis compared to healthy control participants will be mapped using functional MRI.
Differences between groups in somatotopy of the face in the motor cortex will be assessed using fMRI.

Full Information

First Posted
November 2, 2021
Last Updated
June 9, 2022
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05121896
Brief Title
Functional MRI Study Facial Synkinesis
Official Title
Investigating Neural Plasticity and Nuclear Hyperexcitability in Patients With Oral-ocular Facial Synkinesis Using 7 Tesla Functional MRI
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Rationale. Facial synkinesis is one of the most common consequences after facial paralysis, defined as the inability to move muscles due to nerve damage. Facial synkinesis arises during recovery of nerve injury and is characterized by involuntary and synchronous contractions of muscles during facial movements. Patients' quality of life is major influenced by the disease. As patients experience problems with facial movements, this leads to difficulties in expressing emotions, eating, and drinking. A common type of facial synkinesis is oral-ocular synkinesis, defined as eye closure during movement with the mouth. During movements of the mouth, the buccinator muscle plays an essential role. Both the trigeminal and the facial nerve innervate the buccinator muscle, resulting in a complex sensorimotor feedback system between the nerves. Dysregulation of this feedback system is assumed to result in hyperexcitability of the trigeminal and facial nuclei in the pons. In addition, this will lead to cortical plasticity of the sensory and motor areas of the brain. Based on this, the investigators hypothesize dysregulation of the sensorimotor feedback system in patients with facial synkinesis, resulting in differences in the neuroplastic organization of the primary and secondary somatosensory cortexes, the primary motor cortex, the supplementary motor cortex, and the ventral lateral premotor cortex compared to healthy control participants. In addition, the investigators expect hyperexcitability of the trigeminal and facial nuclei. Therefore, this study aims to obtain a more detailed understanding of the neural reorganization of the sensory and motor areas as a consequence of facial synkinesis using 7T fMRI. Objective. To study the neuroplasticity of the brain due to facial synkinesis by assessing the somatotopy of the face on several cortexes of interest (primary and secondary somatosensory cortexes, the primary motor cortex, the supplementary motor cortex, and the ventral lateral premotor cortex) compared to healthy control participants. Study design. A single center imaging study carried out in MUMC+. Study population. Two patients with severe oral-ocular synkinesis will be included in this pilot study. In addition, two age- and sex-matched healthy control participants will be included. Intervention. Every subject will undergo a single functional MRI scan in the 7 Tesla MRI scan of Scannexus. A scanning session takes approximately 1 hour. During the scan, participants are asked to perform motor and sensory tasks. Main study parameters. The main study parameter is the hemodynamic response after stimulation of specific parts of the face. Within the areas of interest (primary motor cortex, the ventral lateral premotor cortex, the supplementary motor cortex, the primary somatosensory cortex (S1), and the secondary somatosensory cortex (S2)), the temporo-spatial brain activity patterns after the different motor and sensory tasks are assessed, and the representation of the face is mapped on the cortexes of interest.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Synkinesis
Keywords
functional MRI (fMRI), Neural plasticity, Nuclear hyperexcitability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with facial synkinesis
Arm Type
Active Comparator
Arm Description
Functional MRI scan of the primary and secondary somatosensory cortexes, the primary motor cortex, the supplementary motor cortex, and the ventral lateral premotor cortex while the participant performs motor and sensory tasks.
Arm Title
Control participants
Arm Type
Active Comparator
Arm Description
Functional MRI scan of the primary and secondary somatosensory cortexes, the primary motor cortex, the supplementary motor cortex, and the ventral lateral premotor cortex while the participant performs motor and sensory tasks.
Intervention Type
Device
Intervention Name(s)
MRI Scan
Intervention Description
7.0 tesla functional MRI scan
Primary Outcome Measure Information:
Title
The neuroplasticity of the brain after facial synkinesis will be measured using functional MRI
Description
Changes in the blood oxygen level dependent (BOLD) contrast as a function of motor and sensory tasks of the face will be measured using fMRI.
Time Frame
Total MRI scan will take 60 minutes
Title
hyperexcitability of the pons as a result of synkinesis will be measured using functional MRI
Description
hyperexcitability of the pons as a result of oral-ocular facial synkinesis compared to the contralateral side or healthy control participants will be measured using fMRI.
Time Frame
Total MRI scan will take 60 minutes
Secondary Outcome Measure Information:
Title
Differences in the somatotopy of the sensory area between patients with oral-ocular facial synkinesis compared to healthy control participants will be mapped using functional MRI.
Description
Differences between groups in somatotopy of the face in the somatosensory cortex will be assessed using fMRI.
Time Frame
Total MRI scan will take 60 minutes
Title
Differences in the somatotopy of the motor area between patients with oral-ocular facial synkinesis compared to healthy control participants will be mapped using functional MRI.
Description
Differences between groups in somatotopy of the face in the motor cortex will be assessed using fMRI.
Time Frame
Total MRI scan will take 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for all participants: absence of facial nerve transposition; participants must be 18 years of age or older; signed informed consent. Inclusion Criteria for patients with facial synkinesis: patients must have severe facial synkinesis based on the Sunnybrook facial grading system at the time the MRI scan is performed synkinesis must occur only on one side of the face Exclusion Criteria for all participants: previous neurosurgery contraindications for MRI investigation, such as a pacemaker, implanted pumps or stimulators, iron materials (e.g., piercings), facial tattoos and permanent make up, or claustrophobia. Exclusion Criteria for control participants: control participants must have no forms of facial paralysis prior to the MRI examination and at the time of the MRI procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefania Tuinder, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Functional MRI Study Facial Synkinesis

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