search
Back to results

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

Primary Purpose

Brain Glioma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Midazolam
Dexmedetomidine
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Glioma focused on measuring midazolam, dexmedetomidine, motor function

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beijing Tiantan Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brain eloquent area glioma group

control group

Arm Description

The brain eloquent area glioma will be diagnosed by MRI scan.

Healthy volunteers without intracranial diseases.

Outcomes

Primary Outcome Measures

Brain network connectivity
will use fMRI and DTI

Secondary Outcome Measures

upper limb's motor function
will use 9-hole peg test and motor/sensory function evaluation
pathological diagnose of glioma
the detailed type of glioma and WHO glioma grade

Full Information

First Posted
June 8, 2019
Last Updated
July 26, 2023
Sponsor
Beijing Tiantan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03984240
Brief Title
The Effects of Mild Sedation on Motor Function Networks in Patients With Brian Gliomas
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Glioma
Keywords
midazolam, dexmedetomidine, motor function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brain eloquent area glioma group
Arm Type
Experimental
Arm Description
The brain eloquent area glioma will be diagnosed by MRI scan.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Healthy volunteers without intracranial diseases.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Participant will be sedated by midazolam.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Participant will be sedated by dexmedetomidine.
Primary Outcome Measure Information:
Title
Brain network connectivity
Description
will use fMRI and DTI
Time Frame
2 hours following sedation
Secondary Outcome Measure Information:
Title
upper limb's motor function
Description
will use 9-hole peg test and motor/sensory function evaluation
Time Frame
2 hours following sedation
Title
pathological diagnose of glioma
Description
the detailed type of glioma and WHO glioma grade
Time Frame
2 weeks after surgery completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan LIN, MD, PhD
Phone
8610-13810108927
Email
linnan127@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nan LIN
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100055
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Lin, MD
Phone
8610-13810108927
Email
linnan127@gmail.com
First Name & Middle Initial & Last Name & Degree
中国

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs