Cervical Spinal Cord InjuryNCT01712698
Diffusion Tensor Imaging to Assess the Functional Outcomes of Adults With Cervical Spinal Cord Injuries
An observational study of Cervical Spinal Cord Injury, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Acute changes in axial diffusivity will correlate with the severity of injury in patients that suffer an acute spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Spinal Cord Injury
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a traumatic cervical spinal cord injury
Who may be able to join
- 18-65 years of age
- Cervical spinal cord injury
- physically and mentally willing to comply with imaging
- lives in immediate area with no plans to relocate
Who cannot join
- Associated moderate to severe head injury
- Active malignancy
- Previous spinal cord injury
- pregnancy
- inability to tolerate MRI scanning
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University, School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Diffusion Tensor MRI to Assess Subacute Functional Outcomes in Patients With Acute Cervical Spinal Cord Injuries
Acute changes in axial diffusivity will correlate with the severity of injury in patients that suffer an acute spinal cord injury.
Read the detailed description
Diffusion tensor imaging (DTI) parameters will correlate with severity of spinal cord injury in SCI patients as seen in rodent models. We will test whether the quantitative decrease in axial (λ║) diffusivity (a biomarker of axonal injury), will predict long-term functional outcomes for patients with a SCI.
Specific Aim: To examine patients after an acute SCI using DTI and to correlate the extent of acute decrease in λ║ with the presenting ASIA motor score and long-term functional outcome of the patient.
- Conditions
- Cervical Spinal Cord Injury
- Keywords
- trauma, spinal cord injury, cervical spine
- Medical subject headings
- Wounds and Injuries, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cervical spinal cord injury | Those patients with an acute cervical spinal cord injury evaluated with DTI MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AISA score
Patients will be followed for the duration of their hospital stay with clinical follow-up out to 2 years. ASIA scores will be correlated with admission DTI findings(Axial Diffusivity).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712698
- Sponsor's protocol ID
- DTI
- Other IDs
- Washington University
- Status last verified
- Apr 2018
- First submitted
- 17 Oct 2012
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Tensor MRI to Assess Subacute Functional Outcomes in Patients With Acute Cervical Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT01712698
- Acronym / sponsor ID
- DTI
- Conditions
- Cervical Spinal Cord Injury
- Keywords
- trauma, spinal cord injury, cervical spine
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 Oct 2012 (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.
Acute changes in axial diffusivity will correlate with the severity of injury in patients that suffer an acute spinal cord injury.
Detailed description
Diffusion tensor imaging (DTI) parameters will correlate with severity of spinal cord injury in SCI patients as seen in rodent models. We will test whether the quantitative decrease in axial (λ║) diffusivity (a biomarker of axonal injury), will predict long-term functional outcomes for patients with a SCI.
Specific Aim: To examine patients after an acute SCI using DTI and to correlate the extent of acute decrease in λ║ with the presenting ASIA motor score and long-term functional outcome of the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical spinal cord injury | – | –Those patients with an acute cervical spinal cord injury evaluated with DTI MRI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a traumatic cervical spinal cord injury
Key inclusion criteria (4 listed)
- 18-65 years of age
- Cervical spinal cord injury
- physically and mentally willing to comply with imaging
- lives in immediate area with no plans to relocate
Key exclusion criteria (5 listed)
- Associated moderate to severe head injury
- Active malignancy
- Previous spinal cord injury
- pregnancy
- inability to tolerate MRI scanning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in AISA score
Time frame: 24 months
Patients will be followed for the duration of their hospital stay with clinical follow-up out to 2 years. ASIA scores will be correlated with admission DTI findings(Axial Diffusivity).
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 3 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cervical Spinal Cord Injury, run by Washington University School of Medicine 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 4 inclusion and 5 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 3 May 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 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?
Change in AISA score (time frame: 24 months). 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 3 May 2018.