Spinal Cord CompressionNCT00280306
White Matter Fiber Tracking and Assessment of White Matter Integrity in the Cervical Spinal Cord
An observational study of Spinal Cord Compression, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
White matter fiber tracking may provide a novel tool to assess the integrity of injured motor tracts in the cervical spine. It provides information about fiber directions which is not given by conventional MRI. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Compression
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Oct 2008
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cervical spinal cord compression
Who may be able to join
- Normal controls Spinal cord injury
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Medical College of Cornell
New York, New York, 10021
About this study
Official title: White Matter Fiber Tracking and Assessment of White Matter Integrity in the Cervical Spinal Cord - Pilot Study
White matter fiber tracking may provide a novel tool to assess the integrity of injured motor tracts in the cervical spine. It provides information about fiber directions which is not given by conventional MRI. White matter fiber tracking in the brain is used at several institutions, including our own medical college, for presurgical planning of tumor excision. We believe that the technical and clinical experience gained for the brain can be applied to fiber tracking in the cervical spine as well.
Read the detailed description
White matter fiber tracking may provide a novel tool to assess the integrity of injured motor tracts in the cervical spine. It provides information about fiber directions which is not given by conventional MRI. White matter fiber tracking in the brain is used at several institutions, including our own medical college, for presurgical planning of tumor excision. We believe that the technical and clinical experience gained for the brain can be applied to fiber tracking in the cervical spine as well. White matter fiber tracking in the cervical spine has some important clinical applications:
- A better understanding of the relationship between abnormal cervical spinal anatomy and the impact on fiber tracts would be helpful in determining the best treatment for a particular patient. It may be able to define the indication and role of surgical decompression and stabilization based on quantifiable and reproducible data obtained with this new imaging technology.
- It could help the surgeon to determine what type of surgical approach to choose (anterior versus posterior surgery, depending on the degree of compression / impingement on nerve fibers).
- Correlation between quantitative diffusion measures and spinal cord injury may be used in monitoring the response to treatment and may therefore be an important parameter for clinicians to follow.
- White matter fiber tracking may also help to determine the pathophysiology underlying cervical spondylotic myelopathy. Currently, there is a debate as to whether cervical spondylitic myelopathy is caused mainly by compressive narrowing of the spinal canal, which may lead to focal ischemia and tissue injury, or whether excessive motion due to cervical spondylosis results in increased strain and shear of spinal axons resulting in injury (Henderson et al., Neurosurgery 56(5):1101-13, 2005). If the latter is correct one would expect diffusion changes along the course of white matter tracks above and below the spondylotic changes.
We will first study a pool of 15 normal control subjects to refine our data acquisition and postprocessing tools, and to sample quantitative diffusion based data for the normal cervical spine. A second group of subjects will include 10 patients with significant cervical spondylosis and upper extremity radiculopathy without myelopathy. The third group will be 10 patients with cervical spondylosis and signs and symptoms of myelopathy. The two patient groups will allow us to define systematic differences between normal values and values in the injured spine.
The DTI data will be processed using tools for artifact correction first and then tools for rendering T2 weighted images, diffusion weighted images, ADC maps and FA values.
- Conditions
- Spinal Cord Compression
- Being tested
- No interventions
- Medical subject headings
- Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging study of white matter in spinal cord; define systematic differences between normal values and values in the injured spine
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study startNov 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord CompressionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Cervical Spine Research Society
- Responsible party
- Principal investigator, Henning U. Voss, Weill Medical College of Cornell University
- Investigators
- Henning U Voss, Principal investigator, Weill Medical College of Cornell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280306
- Sponsor's protocol ID
- 1-Voss
- Status last verified
- Jun 2015
- First submitted
- 17 Jan 2006
- Last updated
- 4 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Matter Fiber Tracking and Assessment of White Matter Integrity in the Cervical Spinal Cord - Pilot Study
- ClinicalTrials.gov ID
- NCT00280306
- Acronym / sponsor ID
- 1-Voss
- Conditions
- Spinal Cord Compression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Cervical Spine Research Society
- Study start
- Nov 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 20 Jan 2006 (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.
White matter fiber tracking may provide a novel tool to assess the integrity of injured motor tracts in the cervical spine. It provides information about fiber directions which is not given by conventional MRI. White matter fiber tracking in the brain is used at several institutions, including our own medical college, for presurgical planning of tumor excision. We believe that the technical and clinical experience gained for the brain can be applied to fiber tracking in the cervical spine as well.
Detailed description
White matter fiber tracking may provide a novel tool to assess the integrity of injured motor tracts in the cervical spine. It provides information about fiber directions which is not given by conventional MRI. White matter fiber tracking in the brain is used at several institutions, including our own medical college, for presurgical planning of tumor excision. We believe that the technical and clinical experience gained for the brain can be applied to fiber tracking in the cervical spine as well. White matter fiber tracking in the cervical spine has some important clinical applications:
- A better understanding of the relationship between abnormal cervical spinal anatomy and the impact on fiber tracts would be helpful in determining the best treatment for a particular patient. It may be able to define the indication and role of surgical decompression and stabilization based on quantifiable and reproducible data obtained with this new imaging technology.
- It could help the surgeon to determine what type of surgical approach to choose (anterior versus posterior surgery, depending on the degree of compression / impingement on nerve fibers).
- Correlation between quantitative diffusion measures and spinal cord injury may be used in monitoring the response to treatment and may therefore be an important parameter for clinicians to follow.
- White matter fiber tracking may also help to determine the pathophysiology underlying cervical spondylotic myelopathy. Currently, there is a debate as to whether cervical spondylitic myelopathy is caused mainly by compressive narrowing of the spinal canal, which may lead to focal ischemia and tissue injury, or whether excessive motion due to cervical spondylosis results in increased strain and shear of spinal axons resulting in injury (Henderson et al., Neurosurgery 56(5):1101-13, 2005). If the latter is correct one would expect diffusion changes along the course of white matter tracks above and below the spondylotic changes.
We will first study a pool of 15 normal control subjects to refine our data acquisition and postprocessing tools, and to sample quantitative diffusion based data for the normal cervical spine. A second group of subjects will include 10 patients with significant cervical spondylosis and upper extremity radiculopathy without myelopathy. The third group will be 10 patients with cervical spondylosis and signs and symptoms of myelopathy. The two patient groups will allow us to define systematic differences between normal values and values in the injured spine.
The DTI data will be processed using tools for artifact correction first and then tools for rendering T2 weighted images, diffusion weighted images, ADC maps and FA values.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cervical spinal cord compression
Key inclusion criteria (1 listed)
- Normal controls Spinal cord injury
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| No interventionsNo intervention | Other | – |
Primary outcome
Imaging study of white matter in spinal cord; define systematic differences between normal values and values in the injured spine
Time frame: Up to 3 years
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 2015.
Related trials for Spinal Cord Compression
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Cervical Radiculopathy, Cervical Myelomalacia
Active, not recruitingPhase 1
Phase I Study of Feasibility of Single Session Spine Stereotactic Radiosurgery (SSRS) in the Primary Management in Patients With Inoperable, Previously Unirradiated Metastatic Epidural Spinal Cord Compression (MESCC)
Metastatic Epidural Spinal Cord Compression
Active, not recruitingPhase 2
Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord
Malignant Digestive System Neoplasm, Metastatic Head and Neck Carcinoma
RecruitingPhase 2
Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery
Spinal Cord, Metastatic Epidural
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.
Henning U Voss principal investigator
Weill Medical College of Cornell
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 Spinal Cord Compression, run by Weill Medical College of Cornell 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 1 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 4 Jun 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 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?
Imaging study of white matter in spinal cord; define systematic differences between normal values and values in the injured spine (time frame: Up to 3 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 2015.