Amyotrophic Lateral SclerosisNCT04952025
Quantitative Analysis of Precise Brain Volume in Amyotrophic Lateral Sclerosis
An observational study of Amyotrophic Lateral Sclerosis, run by Peking University Third Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Diagnostic criteria
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: 32
Who may be able to join
- Diagnosed ALS patients
- healthy volunteers
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
About this study
Official title: 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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Diagnostic criteria
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic criteriaDiagnostic test
Diagnostic criteria of ALS
| Study group | Role | What they receive |
|---|---|---|
| ALS patients | Not described Receives: Diagnostic Test: Diagnostic criteria | |
| normal controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate quantitative analysis of brain volume
Accurate quantitative analysis of brain volume using magnetic resonance brain imaging
Measured: 1 day
Secondary outcomes (1)
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Jan 2015
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Shan Ye, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952025
- Sponsor's protocol ID
- M2020369
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Imaging Study of Amyotrophic Lateral Sclerosis Based on Accurate Brain Volume Quantitative Analysis
- ClinicalTrials.gov ID
- NCT04952025
- Acronym / sponsor ID
- M2020369
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALS patients | – | Diagnostic Test: Diagnostic criteria |
| normal controls | – | – |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- 32
Key inclusion criteria (2 listed)
- Diagnosed ALS patients
- healthy volunteers
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic criteriaDiagnostic criteria of ALS | Diagnostic test | ALS patients |
Primary outcome
Accurate quantitative analysis of brain volume
Time frame: 1 day
Accurate quantitative analysis of brain volume using magnetic resonance brain imaging
1 secondary outcome
general situation
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shan Ye principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurate quantitative analysis of brain volume (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.