Multimodal Brain Imaging Study

NCT04960540 | Unknown DMC

• 1 other identifier: M2018273
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• ALSFRS-R score

  Amyotrophic lateral sclerosis rating scale

  After 1 year of recruitment

Study Arms (4)

impaired speech comprehension processing in ALS

Brain functional network mechanism of impaired speech comprehension processing in ALS

Other: MRI,

language use processing injury in ALS

Brain functional network mechanism of language use processing injury in ALS

Other: MRI,

motor executive processing injury in ALS

Brain functional network mechanism of motor executive processing injury in ALS

Other: MRI,

anguage cognitive impairment in ALS

Brain structural network mechanism of language cognitive impairment in ALS

Other: MRI,

Interventions

MRI, OTHER

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; impaired speech comprehension processing in ALS; language use processing injury in ALS; motor executive processing injury in ALS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

(I) Study population 1\. Inclusion 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 2\. 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: 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

You may qualify if:

• 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
• Ages 18-70
• Agree and sign the informed consent

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking Yniversity Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Shan Ye

  Peking Yniversity Third Hospital Medical

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 14, 2021
• Study Start: August 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: September 1, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)