Multimodal Brain Imaging Study

Sponsor
Peking University Third Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04960540
Collaborator
(none)
40
1
25
1.6

Study Details

Study Description

Brief Summary

To explain the key brain network nodes and their brain mechanisms of ALS language cognitive impairment and decline, reveal the neural mechanism of the association between ALS language cognitive impairment and motor executive function, and provide potential early diagnostic markers and targeted therapeutic targets for ALS language cognitive impairment.

Condition or Disease Intervention/Treatment Phase
  • Other: MRI,

Detailed Description

【 Objective 】 To elucide the key brain network nodes and their brain mechanisms of language cognitive impairment and decline in ALS, and to reveal the neural mechanism of the association between language cognitive impairment and motor executive function in ALS, so as to provide potential early diagnostic markers and targeted therapeutic targets for language cognitive impairment in ALS.

[Design] With the help of multi-modal brain imaging methods such as resting-state functional MRI, task-state functional MRI, structural MRI and diffusion tensor imaging, this project will analyze from multiple dimensions such as brain structure, gray matter morphology, white matter fibrous brain functional activation mode and brain functional connectivity network.

In particular, combined with the brain functional activities of ALS patients in the cognitive processing task of language understanding and language use, the brain network damage of ALS patients in motor and executive function was compared, and the neural activities and network mechanism of specific changes in language cognitive processing in ALS patients were investigated. Combined with the clinical neuropsychological behavior evaluation data, To deeply understand the neural mechanism of language cognitive impairment in ALS patients.

The research will be divided into four parts, including: the brain functional network mechanism of ALS language understanding processing injury, ALS language use processing injury, ALS motor executive processing injury, ALS language cognitive injury brain structural network mechanism.

Ten patients with ALS were included in each part of the study, and 40 patients with ALS in four parts were included in the study. Multimodal magnetic resonance scanning and cognitive assessment were performed.

Normal healthy controls for this study will be provided by the research team of Peking University Magnetic Resonance Imaging Research Center of this project group.

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Multimodal Brain Imaging Study of Language Cognitive Function in Patients With Amyotrophic Lateral Sclerosis
Actual Study Start Date :
Aug 1, 2019
Actual Primary Completion Date :
Nov 1, 2020
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
impaired speech comprehension processing in ALS

Brain functional network mechanism of impaired speech comprehension processing in ALS

Other: MRI,
In this project, multi-modal brain imaging methods, such as resting-state functional MRI, task-state functional MRI, structural MRI and diffusion tensor imaging, will be used to analyze brain structure, gray matter morphology, white matter fibrous brain functional activation mode and brain functional connectivity network, and other dimensions. In particular, combined with the brain functional activities of ALS patients in the cognitive processing task of language understanding and language use, the brain network damage of ALS patients in motor and executive function was compared, and the neural activities and network mechanism of specific changes in language cognitive processing in ALS patients were investigated. Combined with the clinical neuropsychological behavior evaluation data

language use processing injury in ALS

Brain functional network mechanism of language use processing injury in ALS

Other: MRI,
In this project, multi-modal brain imaging methods, such as resting-state functional MRI, task-state functional MRI, structural MRI and diffusion tensor imaging, will be used to analyze brain structure, gray matter morphology, white matter fibrous brain functional activation mode and brain functional connectivity network, and other dimensions. In particular, combined with the brain functional activities of ALS patients in the cognitive processing task of language understanding and language use, the brain network damage of ALS patients in motor and executive function was compared, and the neural activities and network mechanism of specific changes in language cognitive processing in ALS patients were investigated. Combined with the clinical neuropsychological behavior evaluation data

motor executive processing injury in ALS

Brain functional network mechanism of motor executive processing injury in ALS

Other: MRI,
In this project, multi-modal brain imaging methods, such as resting-state functional MRI, task-state functional MRI, structural MRI and diffusion tensor imaging, will be used to analyze brain structure, gray matter morphology, white matter fibrous brain functional activation mode and brain functional connectivity network, and other dimensions. In particular, combined with the brain functional activities of ALS patients in the cognitive processing task of language understanding and language use, the brain network damage of ALS patients in motor and executive function was compared, and the neural activities and network mechanism of specific changes in language cognitive processing in ALS patients were investigated. Combined with the clinical neuropsychological behavior evaluation data

anguage cognitive impairment in ALS

Brain structural network mechanism of language cognitive impairment in ALS

Other: MRI,
In this project, multi-modal brain imaging methods, such as resting-state functional MRI, task-state functional MRI, structural MRI and diffusion tensor imaging, will be used to analyze brain structure, gray matter morphology, white matter fibrous brain functional activation mode and brain functional connectivity network, and other dimensions. In particular, combined with the brain functional activities of ALS patients in the cognitive processing task of language understanding and language use, the brain network damage of ALS patients in motor and executive function was compared, and the neural activities and network mechanism of specific changes in language cognitive processing in ALS patients were investigated. Combined with the clinical neuropsychological behavior evaluation data

Outcome Measures

Primary Outcome Measures

  1. ALSFRS-R score [After 1 year of recruitment]

    Amyotrophic lateral sclerosis rating scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Entry criteria:
  1. Satisfied clinically possible ALS, laboratory supported suspected ALS, clinically suspected ALS or clinically confirmed ALS in the diagnostic criteria of ALS EL Escorial revised in 1998

  2. Ages 18-70

  3. Agree and sign the informed consent

Exclusion Criteria:
    1. Severe respiratory dysfunction, unable to cooperate with NMR examination 2) Severe dysarthria and limb dysfunction, unable to cooperate with the neuropsychological examination 3) Patients with absolute or relative contraindications to MRI, including:
  1. Patients with cardiac pacemakers, cochlear implants, built-in pumps, nerve stimulators, artificial metal heart valves, etc.; B) After ligation of aneurysm clip (except non-paramagnetic, such as titanium alloy); C) Internal ferromagnetic metal implants (excluding metal IUD and fixed dentures); D) Claustrophobic; E) Patients with epilepsy 4) Pregnant patients 5) illiterate

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Yniversity Third Hospital Beijing China

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

  • Study Chair: Shan Ye, Peking Yniversity Third Hospital Medical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04960540
Other Study ID Numbers:
  • M2018273
First Posted:
Jul 14, 2021
Last Update Posted:
Jul 14, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2021