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出境医 / 临床实验 / The Effects of Mild Sedation on Motor Function Networks in Patients With Brian Gliomas

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

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Brain Glioma Drug: Midazolam Drug: Dexmedetomidine Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Brain eloquent area glioma group
The brain eloquent area glioma will be diagnosed by MRI scan.
 Drug: Midazolam
Participant will be sedated by midazolam.

Drug: Dexmedetomidine
Participant will be sedated by dexmedetomidine.
Active Comparator: control group
Healthy volunteers without intracranial diseases.
 Drug: Midazolam
Participant will be sedated by midazolam.

Drug: Dexmedetomidine
Participant will be sedated by dexmedetomidine.
Outcome Measures
Primary Outcome Measures :
  1. Brain network connectivity [ Time Frame: 2 hours following sedation ]
    will use fMRI and DTI


Secondary Outcome Measures :
  1. upper limb's motor function [ Time Frame: 2 hours following sedation ]
    will use 9-hole peg test and motor/sensory function evaluation

  2. pathological diagnose of glioma [ Time Frame: 2 weeks after surgery completion ]
    the detailed type of glioma and WHO glioma grade


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Nan LIN, MD, PhD 8610-13810108927 linnan127@gmail.com

Locations
Layout table for location information
China, Beijing
Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100055
Contact: Nan Lin, MD    8610-13810108927    linnan127@gmail.com   
Contact: 中国         
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
Layout table for investigator information
Principal Investigator: Nan LIN Beijing Tiantan Hospital
Tracking Information
First Submitted Date  ICMJE June 8, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date December 22, 2020
Actual Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019) 		Brain network connectivity [ Time Frame: 2 hours following sedation ]
will use fMRI and DTI
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • upper limb's motor function [ Time Frame: 2 hours following sedation ]
    will use 9-hole peg test and motor/sensory function evaluation
  • pathological diagnose of glioma [ Time Frame: 2 weeks after surgery completion ]
    the detailed type of glioma and WHO glioma grade
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Mild Sedation on Motor Function Networks in Patients With Brian Gliomas
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain Glioma
Intervention  ICMJE
  • Drug: Midazolam
    Participant will be sedated by midazolam.
  • Drug: Dexmedetomidine
    Participant will be sedated by dexmedetomidine.
Study Arms  ICMJE
  • Experimental: Brain eloquent area glioma group
    The brain eloquent area glioma will be diagnosed by MRI scan.
    Interventions:
    • Drug: Midazolam
    • Drug: Dexmedetomidine
  • Active Comparator: control group
    Healthy volunteers without intracranial diseases.
    Interventions:
    • Drug: Midazolam
    • Drug: Dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Nan LIN, MD, PhD 8610-13810108927 linnan127@gmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984240
Other Study ID Numbers  ICMJE 81701038
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nan Lin, Beijing Tiantan Hospital
Study Sponsor  ICMJE Beijing Tiantan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nan LIN Beijing Tiantan Hospital
PRS Account Beijing Tiantan Hospital
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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