Amyotrophic Lateral Sclerosis (ALS)NCT01945853
Magnetic Resonance Imaging (MRI) in Amyotrophic Lateral Sclerosis (ALS)
A study testing 7 Tesla MRI in people with Amyotrophic Lateral Sclerosis (ALS), run by Johns Hopkins University at 1 site in United States.
Trial summary
This is a pilot study to identify the degree of grey and white matter involvement in patients with Amyotrophic Lateral Sclerosis (ALS) utilizing non-invasive techniques. The imaging to be utilized will be the 7 Tesla (7T) magnetic resonance imaging (MRI) of the brain. 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 (ALS)
- What is being tested?
- 7 Tesla MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Apr 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
- Males and Females who are 18 - 80 years old.
- The participants will meet the standard diagnostic criteria for possible or probable ALS (based on El Escorial criteria). They will have been diagnosed by a Johns Hopkins Neurologist.
- Healthy controls will be recruited by their interest in assisting the ALS population.
Who cannot join
- Forced vital capacity less than 60 % of predicted value.
- Documented orthopnea on ALSFRS-R or otherwise unable to lie flat in an MRI scanner for the duration of the study.
- Presence of pacemakers, aneurysm clips, shrapnel or otherwise disallowed implanted metallic devices for obtaining an MRI scan.
- Pregnant or lactating females
- Glomerular filtration rate (GFR) less than 60
- History of: encephalitis, extensive white matter disease, intracranial hemorrhage, cerebral palsy, allergy to dye and/or IV drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Imaging Myelin Injury in Amyotrophic Lateral Sclerosis (ALS)
This is a pilot study to identify the degree of grey and white matter involvement in patients with Amyotrophic Lateral Sclerosis (ALS) utilizing non-invasive techniques. The imaging to be utilized will be the 7 Tesla (7T) magnetic resonance imaging (MRI) of the brain. These results will be correlated to the ALS Functional Rating Scale - Revised (ALSFRS-R) score to assess if any changes in MRI can be predictive in the disability of the ALS patients at baseline and at 6 month intervals. The participants will be asked to return every 6 months for a neurological examination, ALSFRS-R assessment, measurement of the vital capacity and MRI as outlined above to monitor progression of the disease.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- 7 Tesla MRI
- 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.
7 Tesla MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| 7 Tesla MRI | Experimental | 7T MRI will be done on ALS patients at baseline and at 6 month intervals. Receives: Device: 7 Tesla MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Changes in ALS Patients Vs Healthy Controls
Voxel Based Morphometry will be utilized to look for any changes in the MRI results comparing ALS subjects to healthy volunteers.
Measured: 2 years
Secondary outcomes (1)
MRI Changes in ALS Patients
Voxel Based Morphometry will be utilized to look for any changes in the MRI results comparing ALS subjects comparing ALS subjects of differing clinical severity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jeffrey Rothstein, Johns Hopkins University
- Investigators
- Jeffrey D Rothstein, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945853
- Sponsor's protocol ID
- NA_00080565
- Status last verified
- Aug 2015
- First submitted
- 16 Sep 2013
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Myelin Injury in Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT01945853
- Acronym / sponsor ID
- NA_00080565
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 19 Sep 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.
This is a pilot study to identify the degree of grey and white matter involvement in patients with Amyotrophic Lateral Sclerosis (ALS) utilizing non-invasive techniques. The imaging to be utilized will be the 7 Tesla (7T) magnetic resonance imaging (MRI) of the brain. These results will be correlated to the ALS Functional Rating Scale - Revised (ALSFRS-R) score to assess if any changes in MRI can be predictive in the disability of the ALS patients at baseline and at 6 month intervals. The participants will be asked to return every 6 months for a neurological examination, ALSFRS-R assessment, measurement of the vital capacity and MRI as outlined above to monitor progression of the disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7 Tesla MRI | Experimental | Device: 7 Tesla MRI7T MRI will be done on ALS patients at baseline and at 6 month intervals. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and Females who are 18 - 80 years old.
- The participants will meet the standard diagnostic criteria for possible or probable ALS (based on El Escorial criteria). They will have been diagnosed by a Johns Hopkins Neurologist.
- Healthy controls will be recruited by their interest in assisting the ALS population.
Key exclusion criteria (6 listed)
- Forced vital capacity less than 60 % of predicted value.
- Documented orthopnea on ALSFRS-R or otherwise unable to lie flat in an MRI scanner for the duration of the study.
- Presence of pacemakers, aneurysm clips, shrapnel or otherwise disallowed implanted metallic devices for obtaining an MRI scan.
- Pregnant or lactating females
- Glomerular filtration rate (GFR) less than 60
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 |
|---|---|---|
| 7 Tesla MRI | Device | 7 Tesla MRI |
Primary outcome
MRI Changes in ALS Patients Vs Healthy Controls
Time frame: 2 years
Voxel Based Morphometry will be utilized to look for any changes in the MRI results comparing ALS subjects to healthy volunteers.
1 secondary outcome
MRI Changes in ALS Patients
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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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.
Jeffrey D Rothstein, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7 Tesla MRI in people with Amyotrophic Lateral Sclerosis (ALS), run by Johns Hopkins University 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: withdrawn, as of the sponsor's last update on 1 Sep 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
MRI Changes in ALS Patients Vs Healthy Controls (time frame: 2 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 1 Sep 2015.