Quantitative Analysis of Precise Brain Volume in Amyotrophic Lateral Sclerosis

June 27, 2021 updated by: Peking University Third Hospital

Brain Imaging Study of Amyotrophic Lateral Sclerosis Based on Accurate Brain Volume Quantitative Analysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

32

Description

Inclusion Criteria:

  • Diagnosed ALS patients
  • healthy volunteers

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ALS patients
Diagnostic test: Diagnostic criteria
Diagnostic criteria of ALS
normal controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accurate quantitative analysis of brain volume
Time Frame: 1 day
Accurate quantitative analysis of brain volume using magnetic resonance brain imaging
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
general situation
Time Frame: 1 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Collaborators

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Shan Ye, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

January 31, 2021

Study Completion (ACTUAL)

January 31, 2021

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

June 27, 2021

First Posted (ACTUAL)

July 7, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2021

Last Update Submitted That Met QC Criteria

June 27, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2020369

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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