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

Brain Glioma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03984240
• Other study ID #: 81701038
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Beijing Tiantan Hospital
• Contact: Nan LIN, MD, PhD
• Phone: 8610-13810108927
• Email: linnan127[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Glioma
• Glioma

Intervention

Drug:
• Midazolam
Participant will be sedated by midazolam.
• Dexmedetomidine
Participant will be sedated by dexmedetomidine.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain network connectivity	will use fMRI and DTI	2 hours following sedation
Secondary	upper limb's motor function	will use 9-hole peg test and motor/sensory function evaluation	2 hours following sedation
Secondary	pathological diagnose of glioma	the detailed type of glioma and WHO glioma grade	2 weeks after surgery completion