Quantitative Analysis of Precise Brain Volume in Amyotrop... | NCT04952025

Studies
Quantitative Analysis of Precise Brain Volume in Amyotrophic Lateral Sclerosis

NCT04952025

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Jul 7, 2021Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Diagnostic criteria

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Jan 31, 2021Actual

Completion Date

Jan 31, 2021Actual

First Submitted Date

Jun 27, 2021

First Submission Date that Met QC Criteria

Jun 27, 2021

First Posted Date

Jul 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2021

Last Update Posted Date

Jul 7, 2021Actual

Name	Class
Chinese University of Hong Kong	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ALS patients			Diagnostic Test: Diagnostic criteria
normal controls

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic criteria	Diagnostic Test	Diagnostic criteria of ALS	ALS patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed ALS patients
healthy volunteers

Exclusion Criteria:

none

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shan Ye	Peking University Third Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital		Beijing	Beijing Municipality	100000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000690	Amyotrophic Lateral Sclerosis

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease

Browse Leaves

Not provided

Browse Branches

Not provided