The Effects of Mild Sedation on Motor Function Networks in Patients With Brian Gliomas

Study Overview
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Brief Summary
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It has been shown through functional MRI (Magnetic Resonance Imaging) that patients with gliomas in eloquent areas have compensated neurological function by virtue of brain post-injury reorganization. Our previous clinical research found that mild sedation could induce and/or exacerbate neurological deficits, especially in limb motor and ataxia function, in these patients presumably by impairing functional compensation,. Nevertheless it is still very unclear how mild sedation affects sensorimotor networks in brains where reorganization may be present. Since eloquent area glioma patients are frequently subjected to sedation, anesthetics, and neurological examinations perioperatively, it is important to investigate how mild sedation interacts with motor network reorganization and functional compensation. Our research in patients with eloquent area gliomas will utilize neurological evaluations and multimodal MRI to explore the changes in brain upper limb' motor network reorganization after mild sedation by different sedatives-anesthetics. The neurological evaluations include sensorimotor function scale and testing tool. Multimodal MRI consists of 3-dimentional structure, blood oxygen-level dependent for cortical activation and diffusion tensor imaging for subcortical conduction. The data from the clinical testing and functional MRI will be processed and analyzed along with other relevant clinical information. This research will answer the question of how mild sedation affects upper limb motor function networks in brains with eloquent area gliomas. This new information will help optimize perioperative anesthetic and sedative choice for patients with eloquent area gliomas.

Official Title
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The Effects of Mild Sedation on Compensatory Upper Limb Motor Function Networks Based on Multimodal Magnetic Resonance Imaging in With Gliomas in Brain Eloquent Areas

Conditions
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Brain Glioma

Intervention / Treatment
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* Drug: Midazolam
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 25 to 60 years old; Diagnosed as intracranial eloquent glioma by MRI, or healthy volunteer without any intracranial disease; Without history of chronic diseases; Without internal and/external metal object; Education background is beyond high school; Right handedness Exclusion Criteria: Unable to cooperate the neurologic function evaluation; Neuropsychiatric disorders and/or taking antipsychotic medications; Drug and/or alcohol abuse; Receiving longterm sedatives and/or analgesics; Pregnant and/or lactation period patients; Present severe cardiovascular diseases; Having claustrophobia; Body mass index equal or more than 35 kg/m2; Anticipated difficult airway; History of severe obstructive sleep apnea; History of reflux

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain eloquent area glioma group<br>The brain eloquent area glioma will be diagnosed by MRI scan. | Drug: Midazolam<br>* Participant will be sedated by midazolam.<br>Drug: Dexmedetomidine<br>* Participant will be sedated by dexmedetomidine.<br>|
| Active Comparator: control group<br>Healthy volunteers without intracranial diseases. | Drug: Midazolam<br>* Participant will be sedated by midazolam.<br>Drug: Dexmedetomidine<br>* Participant will be sedated by dexmedetomidine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain network connectivity | will use fMRI and DTI | 2 hours following sedation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| upper limb's motor function | will use 9-hole peg test and motor/sensory function evaluation | 2 hours following sedation | 
| pathological diagnose of glioma | the detailed type of glioma and WHO glioma grade | 2 weeks after surgery completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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midazolam, dexmedetomidine, motor function