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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04952025
Other study ID # M2020369
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date January 31, 2021

Study information

Verified date June 2021
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Using the original MRI images of 16 ALS patients and 16 normal controls matched by gender, age and education level in the previous study, the differences of brain volume in different parts of ALS patients and normal controls, and the correlation between brain structure and clinical characteristics were compared by precise brain volume quantitative analysis technology.


Description:

This study was a retrospective study. The subjects were 16 ALS patients and 16 normal controls. Previous studies have collected patients' age, gender and education level; The onset site, onset time, bulbar involvement, diagnostic grade, ALSFRS-R score, application of ventilator, application of lirutai, gastrostomy; Age, gender and education level were collected in the control group. Accurate quantitative analysis of brain volume was performed on the original brain MRI images of the two groups.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date January 31, 2021
Est. primary completion date January 31, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Diagnosed ALS patients - healthy volunteers Exclusion Criteria: - none

Study Design


Intervention

Diagnostic Test:
Diagnostic criteria
Diagnostic criteria of ALS

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Peking University Third Hospital Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accurate quantitative analysis of brain volume Accurate quantitative analysis of brain volume using magnetic resonance brain imaging 1 day
Secondary general situation Age, gender and education level were collected; Onset site, onset time, involvement of bulbar, diagnostic grade, ALSFRS-R score, application of ventilator, application of lirutai, gastrostomy 1 day
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