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Clinical Trials/NCT04960540
NCT04960540
Unknown
Not Applicable

Multimodal Brain Imaging Study of Language Cognitive Function in Patients With Amyotrophic Lateral Sclerosis

Peking University Third Hospital1 site in 1 country40 target enrollmentAugust 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amyotrophic Lateral Sclerosis
Sponsor
Peking University Third Hospital
Enrollment
40
Locations
1
Primary Endpoint
ALSFRS-R score
Last Updated
4 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
September 1, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Entry criteria:
  • 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
  • Agree and sign the informed consent

Exclusion Criteria

  • 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: a) 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

Outcomes

Primary Outcomes

ALSFRS-R score

Time Frame: After 1 year of recruitment

Amyotrophic lateral sclerosis rating scale

Study Sites (1)

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