Functional MRI Study Facial Synkinesis

NCT05121896 | Completed DMC

• 1 other identifier: NL78991.068.21
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Synkinesis

Keywords

functional MRI (fMRI); Neural plasticity; Nuclear hyperexcitability

Outcome Measures

Primary Outcomes (2)

• 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.

  Total MRI scan will take 60 minutes

• 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.

  Total MRI scan will take 60 minutes

Secondary Outcomes (2)

• 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.

  Total MRI scan will take 60 minutes

• 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.

  Total MRI scan will take 60 minutes

Study Arms (2)

Patients with facial synkinesis

ACTIVE COMPARATOR

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.

Device: MRI Scan

Control participants

ACTIVE COMPARATOR

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.

Device: MRI Scan

Interventions

MRI Scan DEVICE

7.0 tesla functional MRI scan

Control participants; Patients with facial synkinesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Stefania Tuinder, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 16, 2021
• Study Start: February 1, 2022
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

NL (1)