Investigating Spinal Atrophy in Patients With Spinal InjuryNCT02148887
Plasticity of Grey and White Matter in Response to Motor Skill Training in Healthy Individuals and Those With Spinal Cord Injury
An observational study of Investigating Spinal Atrophy in Patients With Spinal Injury, run by University of Zurich at 1 site in Switzerland.
Trial summary
We aim to investigate the effect of motor skill training of the upper and lower limbs on the function and structure of the CNS as measured by neuroimaging parameters sensitive to changes in tissue volume and density and the properties of myelin. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Investigating Spinal Atrophy in Patients With Spinal Injury
- How many people
- 51 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to May 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with spinal injury
Who may be able to join
- Patients:
- Injury to the spinal cord which leads to any neurological deficits
- able to provide Informed consent
- Controls:
- able to provide informed consent
Who cannot join
- Pregnancy
- MRI incompatible
- Neurologic or physiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
We aim to investigate the effect of motor skill training of the upper and lower limbs on the function and structure of the CNS as measured by neuroimaging parameters sensitive to changes in tissue volume and density and the properties of myelin.
Read the detailed description
Functional recovery following human spinal cord injury (SCI) remains frustratingly limited and the majority of patients are left with severe impairments. While rehabilitative training has been shown to improve clinical outcome following SCI and has a major effect on patients' quality of life, the neuronal mechanisms underpinning neurological and functional recovery are not well understood.
Until recently, degenerative changes in components of the CNS remote to a SCI were thought to occur slowly (over years) and correlate with the degree of disability. Using longitudinal MRI protocols we have shown that these structural changes in fact occur early and progress both at the cord and brain level according to a specific spatial and temporal pattern (Freund et al 2013). It is thought that these trauma-induced structural changes progress retrogradely along central motor nerve fibres of the myelinated corticospinal tract (CST) and this is accompanied over time by shrinkage of corticospinal projecting neuronal bodies. Crucially, patients with less atrophy throughout the CST were those with better clinical recovery at twelve months. Despite this significant recovery advantage in some patients, all participants showed irreversible tissue loss, potentially hindering further recovery. Using the neuroimaging biomarkers established in the previous study cited above, we now aim to assess whether specific and intensive motor learning through tasks for the upper and lower limb might slow or reverse the atrophy seen in the sensorimotor system.
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 |
|---|---|---|
| SCI patients with upper limb impairment - Upper limb training | Not described | |
| SCI patients with lower limb impairment - Lower limb training | Not described | |
| Healthy controls - Upper limb training | Not described | |
| Healthy controls - Lower limb training | Not described | |
| Healthy controls - No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI parameters: tensor based morphometry, longitudinal relaxation rate, magnetisation transfer and diffusion index changes in the cervical and cranial corticospinal tract, basal ganglia, motor, premotor and parietal cortex.
Measured: MRI scans at weekly intervals (day 0, 7, 14, 28 and 84 after commencement of training)
Raw performance data in the upper and lower limb training task, recorded at each training session.
Measured: Training sessions 4x1hour per week for 4 weeks
Secondary outcomes (2)
Overall activity levels as recorded by a worn accelerometer and clinical scoring tests repeated immediately following the first and final training scan sessions (Day 0 and 28) and the 84 day follow-up scan.
Measured: Training sessions 4x1hour per week for 4 weeks; clinical assessments at day 0, 28, 84
3D gait analysis will be performed on certain patients and control subjects at the first and final training scan sessions (Day 28) and the 84 day follow-up scan
Measured: 3D gait analysis at day 0, 28, 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Investigating Spinal Atrophy in Patients With Spinal InjuryStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Wings For Life
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148887
- Sponsor's protocol ID
- KEK-ZH-2013-0559/PB_2016-00624
- Status last verified
- Jul 2018
- First submitted
- 23 May 2014
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasticity of Grey and White Matter in Response to Motor Skill Training in Healthy Individuals and Those With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02148887
- Acronym / sponsor ID
- KEK-ZH-2013-0559/PB_2016-00624
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Foundation Wings For Life
- Study start
- Feb 2014
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 28 May 2014 (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.
We aim to investigate the effect of motor skill training of the upper and lower limbs on the function and structure of the CNS as measured by neuroimaging parameters sensitive to changes in tissue volume and density and the properties of myelin.
Detailed description
Functional recovery following human spinal cord injury (SCI) remains frustratingly limited and the majority of patients are left with severe impairments. While rehabilitative training has been shown to improve clinical outcome following SCI and has a major effect on patients' quality of life, the neuronal mechanisms underpinning neurological and functional recovery are not well understood.
Until recently, degenerative changes in components of the CNS remote to a SCI were thought to occur slowly (over years) and correlate with the degree of disability. Using longitudinal MRI protocols we have shown that these structural changes in fact occur early and progress both at the cord and brain level according to a specific spatial and temporal pattern (Freund et al 2013). It is thought that these trauma-induced structural changes progress retrogradely along central motor nerve fibres of the myelinated corticospinal tract (CST) and this is accompanied over time by shrinkage of corticospinal projecting neuronal bodies. Crucially, patients with less atrophy throughout the CST were those with better clinical recovery at twelve months. Despite this significant recovery advantage in some patients, all participants showed irreversible tissue loss, potentially hindering further recovery. Using the neuroimaging biomarkers established in the previous study cited above, we now aim to assess whether specific and intensive motor learning through tasks for the upper and lower limb might slow or reverse the atrophy seen in the sensorimotor system.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SCI patients with upper limb impairment - Upper limb training | – | – |
| SCI patients with lower limb impairment - Lower limb training | – | – |
| Healthy controls - Upper limb training | – | – |
| Healthy controls - Lower limb training | – | – |
| Healthy controls - No intervention | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with spinal injury
Key inclusion criteria (5 listed)
- Injury to the spinal cord which leads to any neurological deficits
- able to provide Informed consent
- able to provide informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- MRI incompatible
- Neurologic or physiatric disorders
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
MRI parameters: tensor based morphometry, longitudinal relaxation rate, magnetisation transfer and diffusion index changes in the cervical and cranial corticospinal tract, basal ganglia, motor, premotor and parietal cortex.
Time frame: MRI scans at weekly intervals (day 0, 7, 14, 28 and 84 after commencement of training)
Raw performance data in the upper and lower limb training task, recorded at each training session.
Time frame: Training sessions 4x1hour per week for 4 weeks
2 secondary outcomes
Overall activity levels as recorded by a worn accelerometer and clinical scoring tests repeated immediately following the first and final training scan sessions (Day 0 and 28) and the 84 day follow-up scan.
Time frame: Training sessions 4x1hour per week for 4 weeks; clinical assessments at day 0, 28, 84
3D gait analysis will be performed on certain patients and control subjects at the first and final training scan sessions (Day 28) and the 84 day follow-up scan
Time frame: 3D gait analysis at day 0, 28, 84
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 11 Jul 2018.
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 Investigating Spinal Atrophy in Patients With Spinal Injury, run by University of Zurich at 1 site in Switzerland.
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 5 inclusion and 3 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 11 Jul 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 Switzerland. 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?
MRI parameters: tensor based morphometry, longitudinal relaxation rate, magnetisation transfer and diffusion index changes in the cervical and cranial corticospinal tract, basal ganglia, motor, premotor and parietal cortex. (time frame: MRI scans at weekly intervals (day 0, 7, 14, 28 and 84 after commencement of training)). The study lists 2 primary outcomes in all. 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 11 Jul 2018.