Amyotrophic Lateral SclerosisNCT01995903
Developing a Discrimination Model to Diagnose ALS
A study testing MRI(magnetic resonance imaging) in people with Amyotrophic Lateral Sclerosis, run by University of Michigan at 1 site in United States.
Trial summary
To combine several brain imaging techniques to develop a new diagnostic test to help with earlier diagnosis of amyotrophic lateral sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- MRI(magnetic resonance imaging)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Oct 2015
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- subjects with ALS (amyotrophic lateral sclerosis)
- healthy subjects -
Who cannot join
- Active substance abuse
- Has co-morbid psychiatric disease
- Has opportunistic CNS (central nervous system) infection
- Has a history of head injury
- Has a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants)
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: Developing a Discrimination Model to Diagnose ALS Using Advanced MRI Techniques
To combine several brain imaging techniques to develop a new diagnostic test to help with earlier diagnosis of amyotrophic lateral sclerosis.
Read the detailed description
Early diagnosis and lack of understanding of the pathophysiology of ALS remain a significant obstacle to making a timely intervention to help patients suffering from this fatal disease. We envision a future in which neuroimaging techniques will be a critical tool in the diagnostic work-up of ALS. Advanced neuroimaging techniques offer great potential in identifying central nervous system metabolite and cellular alterations in ALS. We propose an innovative approach to combine complementary advanced MRI techniques to interrogate brain chemistry (MRS), brain microstructure (DTI) and brain function (fcMRI) and develop a clinically relevant discriminatory disease model.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- MRI(magnetic resonance imaging)
- 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.
MRI(magnetic resonance imaging)Diagnostic test
Subjects with amyotrophic lateral sclerosis and lower neuron motor skills and healthy subjects will undergo an MRI(magnetic resonance imaging)scans of the brain to assess neurologic condition. The brain scans will take approximately 60 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Amyotrophic lateral sclerosis | Experimental | Clinical examination for ALS(amyotrophic lateral sclerosis) and subjects with lower motor neuron signs will be completed. These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to assess neurological conditions. Receives: Diagnostic Test: MRI(magnetic resonance imaging) |
| Healthy controls (MRI) | Active comparator | These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to compare against diseased subjects. Receives: Diagnostic Test: MRI(magnetic resonance imaging) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developing a Discrimination Model to Diagnose ALS
We will measure brain fractional anisotropy (unitless) using diffusion tensor imaging of ALS patients and compare these to corresponding measures in healthy control subjects as well as patients with lower motor neuron signs only.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startApr 2012
- Primary completionOct 2015
- Study completionOct 2015
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 University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley Foerster, M.D., Principal investigator, University of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995903
- Sponsor's protocol ID
- HUM00061126
- Status last verified
- May 2018
- First submitted
- 4 Nov 2013
- Last updated
- 4 Jun 2018
- 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 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Discrimination Model to Diagnose ALS Using Advanced MRI Techniques
- ClinicalTrials.gov ID
- NCT01995903
- Acronym / sponsor ID
- HUM00061126
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 27 Nov 2013 (estimated)
- 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.
To combine several brain imaging techniques to develop a new diagnostic test to help with earlier diagnosis of amyotrophic lateral sclerosis.
Detailed description
Early diagnosis and lack of understanding of the pathophysiology of ALS remain a significant obstacle to making a timely intervention to help patients suffering from this fatal disease. We envision a future in which neuroimaging techniques will be a critical tool in the diagnostic work-up of ALS. Advanced neuroimaging techniques offer great potential in identifying central nervous system metabolite and cellular alterations in ALS. We propose an innovative approach to combine complementary advanced MRI techniques to interrogate brain chemistry (MRS), brain microstructure (DTI) and brain function (fcMRI) and develop a clinically relevant discriminatory disease model.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amyotrophic lateral sclerosis | Experimental | Diagnostic Test: MRI(magnetic resonance imaging)Clinical examination for ALS(amyotrophic lateral sclerosis) and subjects with lower motor neuron signs will be completed. These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to assess neurological conditions. |
| Healthy controls (MRI) | Active comparator | Diagnostic Test: MRI(magnetic resonance imaging)These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to compare against diseased subjects. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- subjects with ALS (amyotrophic lateral sclerosis)
- healthy subjects -
Key exclusion criteria (6 listed)
- Active substance abuse
- Has co-morbid psychiatric disease
- Has opportunistic CNS (central nervous system) infection
- Has a history of head injury
- Has a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants)
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 |
|---|---|---|
| MRI(magnetic resonance imaging)Subjects with amyotrophic lateral sclerosis and lower neuron motor skills and healthy subjects will undergo an MRI(magnetic resonance imaging)scans of the brain to assess neurologic condition. The brain scans will take approximately 60 minutes to complete. | Diagnostic test | Amyotrophic lateral sclerosis, Healthy controls (MRI) |
Primary outcome
Developing a Discrimination Model to Diagnose ALS
Time frame: 5 years
We will measure brain fractional anisotropy (unitless) using diffusion tensor imaging of ALS patients and compare these to corresponding measures in healthy control subjects as well as patients with lower motor neuron signs only.
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 4 Jun 2018.
- 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.
Bradley Foerster, M.D. principal investigator
University of Michigan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI(magnetic resonance imaging) in people with Amyotrophic Lateral Sclerosis, run by University of Michigan at 1 site in United States.
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 3 inclusion and 6 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 4 Jun 2018. 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 United States. 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?
Developing a Discrimination Model to Diagnose ALS (time frame: 5 years). 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 4 Jun 2018.