Spinal Cord InjuriesNCT03069222
Longitudinal Assessment of Spinal Cord Structural Plasticity Using DTI in SCI Patients
An observational study of Spinal Cord Injuries, run by Kessler Foundation at 1 site in United States.
Trial summary
This study will apply novel magnetic resonance imaging (MRI) techniques to investigation of spinal cord injury (SCI) to learn how nerve fibers repair and neural cells regain ability to control muscle during the rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Standard Rehabilitative Treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 31 Mar 2020
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Twelve (12) individuals with iSCI (within 3 weeks post injury) will be recruited from Kessler Institute for Rehabilitation (KIR). In addition, we will recruit twelve healthy age- and gender-matched controls. All participants will give informed consent. For the SCI group the following clinical evaluations will occur at baseline, 2 weeks, 1 month, 3 months and 6 months by the study physician or clinician.
Who may be able to join
- SCI due to single event traumatic injury; C4-T12 neurological level of injury, AIS grade B,C or D;
- currently medically stable;
- no history of seizure;
- spasticity at a score of 2 or lower assessed using Modified Ashworth Assessment of the upper and lower extremities;
- able to give informed consent;
- to stay still in the MR scanner for ~30 min.
Who cannot join
- MRI contraindications;
- younger than 18 and older than 75 years (this age range will limit contributions from nervous system development and aging to results of the study);
- history of epilepsy and other neurological diseases and trauma;
- drug and alcohol abuse;
- multi injury levels;
- severe craniocerebral injury and
- presence of non-MRI-safe post-operative hardware in the spine or brain.
Trial locations and contacts
1 site in 1 country.
About this study
This study will apply novel magnetic resonance imaging (MRI) techniques to investigation of spinal cord injury (SCI) to learn how nerve fibers repair and neural cells regain ability to control muscle during the rehabilitation. The information gained will be helpful for physicians to make more accurate diagnosis of SCI, predict injury recovery and movement restoration, and develop more effective treatment plans.
Read the detailed description
Today, the International Standards for the Neurological Classification of Spinal Cord Injury (ISNSCI) , which includes tests of motor and cutaneous sensory function, and Spinal Cord Independence Measure (SCIM) are the gold standards for neurological classification of spinal cord injury (SCI). These standard measures have very important applications in the rehabilitation of SCI as primary clinical and outcome measures. Despite the importance and usefulness of their applications, these standard measures have their limitations. For example, ISNSCI, intended to be a clinical classification system, is subjective and relatively insensitive to incremental neurophysiological and functional changes during both acute and chronic stages of recovery. Moreover, the ISNSCI cannot evaluate the spinal cord (SC) function bellow the neurological level. For some patients such as children and patients with concomitant brain injuries, reliable evaluation cannot be completed due to their limited cognitive engagement in the evaluation process. Magnetic resonance imaging (MRI) has been proposed as a more objective tool to help clinicians make prognosis. However, recent study showed that conventional clinical MRI does not correlate well with scores measured with ISNSCI.
Diffusion Tensor Imaging (DTI) is an advanced MRI tool capable of probing white matter integrity information through measuring directional diffusion of water molecules, thus providing more microscopic details than conventional MRI. Recent findings suggest that DTI is a promising, non-invasive and objective tool for evaluating and monitoring structural changes within white matter axon pathways after SCI. Our preliminary data showed significant deviation of DTI indices from normative values of healthy subjects in a SCI patient whose conventional T2 scans appeared to be normal (see preliminary data section). A likely explanation for this observed alteration of DTI indices is degeneration and demyelization in descending axonal pathways. Although DTI has been used in animal models to measure the evolution of the injury in the SC and showed great promise in detection of pathological changes in SC, no longitudinal DTI data obtained from human SC are available to indicate sensitivity of DTI technique in detecting SCI progression or recovery. Is DTI capable of detecting structural changes taking place in the SC over the course of rehabilitation in individuals with SCI? Will these measured DTI parameters correlate with ISNSCI-based scores? The fundamental hypothesis of the current study is that rehabilitation can facilitate SC fiber tract repair along with spontaneous adaptations following the injury to help reconnect some of the injured nerve fibers with motoneurons controlling muscles and this will in turn improve the motoneuron activity to promote muscular function, and all these changes can be detected by the proposed longitudinal DTI protocols and standard clinical tools for motor function evaluation. The expected results gained by this longitudinal study would support the application of DTI in monitoring plastic changes in the injured SC and the DTI-derived measures could potentially aid clinicians make more objective diagnosis of the injury and estimate its progression, which are critical in planning targeted therapies. However, it is out of the scope of this proposal to distinguish contributions to structural changes occurring in the SC between spontaneous and treatment factors. Because it is unethical to not treat patients, this limitation cannot be overcome in the current human study. Given the primary focus of the study being longitudinal tracking of SC structural changes using neuroimaging rather than determining relative contributions to these changes by spontaneous recovery and treatment, the limitation should not significantly influence the quality of our study. To test the hypothesis, the investigators propose the following Specific Aims.
Aim 1: Track SC structural changes in patients with incomplete SCI (iSCI) using DTI. Each patient in the proposed study will be scanned covering entire cervical region of the SC using a DTI sequence at baseline, 2 weeks, 1 month, 3 month and 6 month after start of standard rehabilitation intervention. DTI indices (see methods for details) will be quantified and compared across all time points. Previous longitudinal brain DTI human and animal studies suggest that DTI is sensitive to detect brain whiter matter structural changes 24 hours (animal study) and 3 months (unpublished human DTI results by PI's group) after brain injury, and 6 month after initial scan in patients with Amyotrophic lateral sclerosis(ALS) (DTI data were only available 6 months after initial scan in this study). The investigators hypothesize that the proposed DTI protocol will be able to capture structural changes in SCI during its recovery course.
Aim 2: Correlate the SC plasticity manifested by changes in DTI indices with clinical assessments of injury and sensorimotor function. Quantitative DTI indices will be correlated to clinical diagnoses of SCI and clinical evaluations of upper and lower limb sensorimotor function of the patients. It is hypothesized that the DTI index of SCI will significantly be correlated with clinical diagnosis and scores of upper and lower sensorimotor function. The DTI parameter holds great promise to be a biomarker of SCI and is expected to have prognostic value in predicting functional outcome of a rehabilitation program.
- Conditions
- Spinal Cord Injuries
- Being tested
- Standard Rehabilitative Treatment
- Keywords
- diffusion tensor imaging
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Rehabilitative TreatmentOther
The patients will participate in standard but comprehensive SCI specific rehabilitation therapy provided by the SCI program at KIR. The therapy consists of 3 hours per day, 5 days a week. Motor function therapy includes standardized procedures for range of motion, passive and active muscle activities, and therapies to improve mobility. The treatment program for the enrolled patients will be standardized by Dr. Kirshblum, Director of the SCI program at KIR and a Co-Investigator of the study. Patients usually receive 4 weeks of rehabilitation treatment; however, if any of them are discharged earlier from KIR, their out-patient treatment activities will be monitored and the patients will be tested based on the planned schedule.
| Study group | Role | What they receive |
|---|---|---|
| Patient | SCI patients enrolled at Kessler Institute Rehabiliation Receives: Other: Standard Rehabilitative Treatment | |
| Control | age and gender matched with patient enrolled |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Neurological examination will be performed using the ISNCSCI. Sensory scores and lower and upper extremity motor scores (LEMS and UEMS) are derived at the time of this exam. The ISNCSCI and all examinations described below will be performed following the same schedule as the imaging (DTI, T2, T2*) evaluation (baseline, 2 weeks, 1 month, 3 months, and 6 months after commencement of rehabilitation therapy). The LEMS measures strength in five muscle groups bilaterally (hip flexors, knee flexors, extensors, and ankle dorsiflexors) and the UEMS also assess strength bilaterally in 5 muscle groups (elbow flexors, elbow extensors, wrist extensors, finger flexors, finger abductors) with the modified British Medical Research Council scale and is performed during the ISNCSCI examination.
Measured: changes within 6 months after participant enrolls.
Modified Ashworth Scale (MAS)
Spasticity assessments will be performed at each visit using the MAS. It tests the resistance to passive movement about a joint with vary degrees of velocity. The scores range from 0 to 4, with 6 choices (0, 1, 1+, 2, 3, and 4). A score of 0 indicates no resistance, and 4 indicates rigidity. The MAS scores will be averaged across 5 muscle groups bilaterally for lower extremities and 5 muscle groups for upper extremities. An experienced therapist will perform all the evaluations for all the visits and all subjects.
Measured: changes within 6 months after participant enrolls.
Spinal Cord Independence measure III (SCIM III)
The SCIM is a measure of functional ability developed specifically for individuals with SCI to evaluate their performance of activities of daily living and to make functional assessments of this population sensitive to change. SCIM scores a task higher in patients who accomplish it with less assistannce, aids, or medical compromise than other patients. The SCIM III to be adopted by the current study is composed of 19 items in 3 subscales: (a) self-care; (b) respiration and sphincter management; and (c) mobility. The total score ranges from 0 to 100. Mobility is subdivided into "room and toilet" and "indoors and outdoors". The items are weighted in terms of their assumed clinical relevance. The SCIM III is a valid and reliable measure and is recommended as a primary outcome measure to assess functional recovery in individuals with SCI.
Measured: changes within 6 months after participant enrolls.
Secondary outcomes (1)
Diffusion Tensor Image
Being an advanced MRI tool, DTI provides excellent structural information on microscopic level such as remyelination which plays an important role in rehabilitation of SCI.
Measured: before [baseline] and 2 weeks, 1 month, 3 months and 6 months after commencement of rehabilitative treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Apr 2016
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe 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
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing Yao, PhD, Kessler Foundation
- Investigators
- Bing Yao, Ph.D., Principal investigator, Kessler Fondation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069222
- Sponsor's protocol ID
- Kessler
- Status last verified
- Sep 2020
- First submitted
- 14 Feb 2017
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kirshblum SC, Waring W, Biering-Sorensen F, Burns SP, Johansen M, Schmidt-Read M, Donovan W, Graves D, Jha A, Jones L, Mulcahey MJ, Krassioukov A. Reference for the 2011 revision of the International Standards for Neurological Classification of Spinal Cord Injury. J Spinal Cord Med. 2011 Nov;34(6):547-54. doi: 10.1179/107902611X13186000420242.
PubMed 22330109Marino RJ, Graves DE. Metric properties of the ASIA motor score: subscales improve correlation with functional activities. Arch Phys Med Rehabil. 2004 Nov;85(11):1804-10. doi: 10.1016/j.apmr.2004.04.026.
PubMed 15520975Mulcahey MJ, Samdani AF, Gaughan JP, Barakat N, Faro S, Shah P, Betz RR, Mohamed FB. Diagnostic accuracy of diffusion tensor imaging for pediatric cervical spinal cord injury. Spinal Cord. 2013 Jul;51(7):532-7. doi: 10.1038/sc.2013.36. Epub 2013 Apr 23.
PubMed 23608812Chang Y, Jung TD, Yoo DS, Hyun JK. Diffusion tensor imaging and fiber tractography of patients with cervical spinal cord injury. J Neurotrauma. 2010 Nov;27(11):2033-40. doi: 10.1089/neu.2009.1265.
PubMed 20822462Cheran S, Shanmuganathan K, Zhuo J, Mirvis SE, Aarabi B, Alexander MT, Gullapalli RP. Correlation of MR diffusion tensor imaging parameters with ASIA motor scores in hemorrhagic and nonhemorrhagic acute spinal cord injury. J Neurotrauma. 2011 Sep;28(9):1881-92. doi: 10.1089/neu.2010.1741. Epub 2011 Aug 29.
PubMed 21875333Toma K, Matsuoka T, Immisch I, Mima T, Waldvogel D, Koshy B, Hanakawa T, Shill H, Hallett M. Generators of movement-related cortical potentials: fMRI-constrained EEG dipole source analysis. Neuroimage. 2002 Sep;17(1):161-73. doi: 10.1006/nimg.2002.1165.
PubMed 12482074Freund P, Curt A, Friston K, Thompson A. Tracking changes following spinal cord injury: insights from neuroimaging. Neuroscientist. 2013 Apr;19(2):116-28. doi: 10.1177/1073858412449192. Epub 2012 Jun 22.
PubMed 22730072Brennan FH, Cowin GJ, Kurniawan ND, Ruitenberg MJ. Longitudinal assessment of white matter pathology in the injured mouse spinal cord through ultra-high field (16.4 T) in vivo diffusion tensor imaging. Neuroimage. 2013 Nov 15;82:574-85. doi: 10.1016/j.neuroimage.2013.06.019. Epub 2013 Jun 14.
PubMed 23770410Keil C, Prell T, Peschel T, Hartung V, Dengler R, Grosskreutz J. Longitudinal diffusion tensor imaging in amyotrophic lateral sclerosis. BMC Neurosci. 2012 Nov 8;13:141. doi: 10.1186/1471-2202-13-141.
PubMed 23134591Mac Donald CL, Dikranian K, Song SK, Bayly PV, Holtzman DM, Brody DL. Detection of traumatic axonal injury with diffusion tensor imaging in a mouse model of traumatic brain injury. Exp Neurol. 2007 May;205(1):116-31. doi: 10.1016/j.expneurol.2007.01.035. Epub 2007 Feb 12.
PubMed 17368446Koskinen E, Brander A, Hakulinen U, Luoto T, Helminen M, Ylinen A, Ohman J. Assessing the state of chronic spinal cord injury using diffusion tensor imaging. J Neurotrauma. 2013 Sep 15;30(18):1587-95. doi: 10.1089/neu.2013.2943. Epub 2013 Aug 9.
PubMed 23758292ASHWORTH B. PRELIMINARY TRIAL OF CARISOPRODOL IN MULTIPLE SCLEROSIS. Practitioner. 1964 Apr;192:540-2. No abstract available.
PubMed 14143329Kirshblum S, Millis S, McKinley W, Tulsky D. Late neurologic recovery after traumatic spinal cord injury. Arch Phys Med Rehabil. 2004 Nov;85(11):1811-7. doi: 10.1016/j.apmr.2004.03.015.
PubMed 15520976Anderson K, Aito S, Atkins M, Biering-Sorensen F, Charlifue S, Curt A, Ditunno J, Glass C, Marino R, Marshall R, Mulcahey MJ, Post M, Savic G, Scivoletto G, Catz A; Functional Recovery Outcome Measures Work Group. Functional recovery measures for spinal cord injury: an evidence-based review for clinical practice and research. J Spinal Cord Med. 2008;31(2):133-44. doi: 10.1080/10790268.2008.11760704.
PubMed 18581660Catz A, Itzkovich M, Tesio L, Biering-Sorensen F, Weeks C, Laramee MT, Craven BC, Tonack M, Hitzig SL, Glaser E, Zeilig G, Aito S, Scivoletto G, Mecci M, Chadwick RJ, El Masry WS, Osman A, Glass CA, Silva P, Soni BM, Gardner BP, Savic G, Bergstrom EM, Bluvshtein V, Ronen J. A multicenter international study on the Spinal Cord Independence Measure, version III: Rasch psychometric validation. Spinal Cord. 2007 Apr;45(4):275-91. doi: 10.1038/sj.sc.3101960. Epub 2006 Aug 15.
PubMed 16909143
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Spinal Cord Structural Plasticity Using DTI in SCI Patients
- ClinicalTrials.gov ID
- NCT03069222
- Acronym / sponsor ID
- Kessler
- Conditions
- Spinal Cord Injuries
- Keywords
- diffusion tensor imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 3 Mar 2017 (actual)
- 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 study will apply novel magnetic resonance imaging (MRI) techniques to investigation of spinal cord injury (SCI) to learn how nerve fibers repair and neural cells regain ability to control muscle during the rehabilitation. The information gained will be helpful for physicians to make more accurate diagnosis of SCI, predict injury recovery and movement restoration, and develop more effective treatment plans.
Detailed description
Today, the International Standards for the Neurological Classification of Spinal Cord Injury (ISNSCI) , which includes tests of motor and cutaneous sensory function, and Spinal Cord Independence Measure (SCIM) are the gold standards for neurological classification of spinal cord injury (SCI). These standard measures have very important applications in the rehabilitation of SCI as primary clinical and outcome measures. Despite the importance and usefulness of their applications, these standard measures have their limitations. For example, ISNSCI, intended to be a clinical classification system, is subjective and relatively insensitive to incremental neurophysiological and functional changes during both acute and chronic stages of recovery. Moreover, the ISNSCI cannot evaluate the spinal cord (SC) function bellow the neurological level. For some patients such as children and patients with concomitant brain injuries, reliable evaluation cannot be completed due to their limited cognitive engagement in the evaluation process. Magnetic resonance imaging (MRI) has been proposed as a more objective tool to help clinicians make prognosis. However, recent study showed that conventional clinical MRI does not correlate well with scores measured with ISNSCI.
Diffusion Tensor Imaging (DTI) is an advanced MRI tool capable of probing white matter integrity information through measuring directional diffusion of water molecules, thus providing more microscopic details than conventional MRI. Recent findings suggest that DTI is a promising, non-invasive and objective tool for evaluating and monitoring structural changes within white matter axon pathways after SCI. Our preliminary data showed significant deviation of DTI indices from normative values of healthy subjects in a SCI patient whose conventional T2 scans appeared to be normal (see preliminary data section). A likely explanation for this observed alteration of DTI indices is degeneration and demyelization in descending axonal pathways. Although DTI has been used in animal models to measure the evolution of the injury in the SC and showed great promise in detection of pathological changes in SC, no longitudinal DTI data obtained from human SC are available to indicate sensitivity of DTI technique in detecting SCI progression or recovery. Is DTI capable of detecting structural changes taking place in the SC over the course of rehabilitation in individuals with SCI? Will these measured DTI parameters correlate with ISNSCI-based scores? The fundamental hypothesis of the current study is that rehabilitation can facilitate SC fiber tract repair along with spontaneous adaptations following the injury to help reconnect some of the injured nerve fibers with motoneurons controlling muscles and this will in turn improve the motoneuron activity to promote muscular function, and all these changes can be detected by the proposed longitudinal DTI protocols and standard clinical tools for motor function evaluation. The expected results gained by this longitudinal study would support the application of DTI in monitoring plastic changes in the injured SC and the DTI-derived measures could potentially aid clinicians make more objective diagnosis of the injury and estimate its progression, which are critical in planning targeted therapies. However, it is out of the scope of this proposal to distinguish contributions to structural changes occurring in the SC between spontaneous and treatment factors. Because it is unethical to not treat patients, this limitation cannot be overcome in the current human study. Given the primary focus of the study being longitudinal tracking of SC structural changes using neuroimaging rather than determining relative contributions to these changes by spontaneous recovery and treatment, the limitation should not significantly influence the quality of our study. To test the hypothesis, the investigators propose the following Specific Aims.
Aim 1: Track SC structural changes in patients with incomplete SCI (iSCI) using DTI. Each patient in the proposed study will be scanned covering entire cervical region of the SC using a DTI sequence at baseline, 2 weeks, 1 month, 3 month and 6 month after start of standard rehabilitation intervention. DTI indices (see methods for details) will be quantified and compared across all time points. Previous longitudinal brain DTI human and animal studies suggest that DTI is sensitive to detect brain whiter matter structural changes 24 hours (animal study) and 3 months (unpublished human DTI results by PI's group) after brain injury, and 6 month after initial scan in patients with Amyotrophic lateral sclerosis(ALS) (DTI data were only available 6 months after initial scan in this study). The investigators hypothesize that the proposed DTI protocol will be able to capture structural changes in SCI during its recovery course.
Aim 2: Correlate the SC plasticity manifested by changes in DTI indices with clinical assessments of injury and sensorimotor function. Quantitative DTI indices will be correlated to clinical diagnoses of SCI and clinical evaluations of upper and lower limb sensorimotor function of the patients. It is hypothesized that the DTI index of SCI will significantly be correlated with clinical diagnosis and scores of upper and lower sensorimotor function. The DTI parameter holds great promise to be a biomarker of SCI and is expected to have prognostic value in predicting functional outcome of a rehabilitation program.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Standard Rehabilitative TreatmentSCI patients enrolled at Kessler Institute Rehabiliation |
| Control | – | –age and gender matched with patient enrolled |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Twelve (12) individuals with iSCI (within 3 weeks post injury) will be recruited from Kessler Institute for Rehabilitation (KIR). In addition, we will recruit twelve healthy age- and gender-matched controls. All participants will give informed consent. For the SCI group the following clinical evaluations will occur at baseline, 2 weeks, 1 month, 3 months and 6 months by the study physician or clinician.
Key inclusion criteria (6 listed)
- SCI due to single event traumatic injury; C4-T12 neurological level of injury, AIS grade B,C or D;
- currently medically stable;
- no history of seizure;
- spasticity at a score of 2 or lower assessed using Modified Ashworth Assessment of the upper and lower extremities;
- able to give informed consent;
Key exclusion criteria (7 listed)
- MRI contraindications;
- younger than 18 and older than 75 years (this age range will limit contributions from nervous system development and aging to results of the study);
- history of epilepsy and other neurological diseases and trauma;
- drug and alcohol abuse;
- multi injury levels;
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 |
|---|---|---|
| Standard Rehabilitative TreatmentThe patients will participate in standard but comprehensive SCI specific rehabilitation therapy provided by the SCI program at KIR. The therapy consists of 3 hours per day, 5 days a week. Motor function therapy includes standardized procedures for range of motion, passive and active muscle activities, and therapies to improve mobility. The treatment program for the enrolled patients will be standardized by Dr. Kirshblum, Director of the SCI program at KIR and a Co-Investigator of the study. Patients usually receive 4 weeks of rehabilitation treatment; however, if any of them are discharged earlier from KIR, their out-patient treatment activities will be monitored and the patients will be tested based on the planned schedule. | Other | Patient |
Primary outcome
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time frame: changes within 6 months after participant enrolls.
Neurological examination will be performed using the ISNCSCI. Sensory scores and lower and upper extremity motor scores (LEMS and UEMS) are derived at the time of this exam. The ISNCSCI and all examinations described below will be performed following the same schedule as the imaging (DTI, T2, T2*) evaluation (baseline, 2 weeks, 1 month, 3 months, and 6 months after commencement of rehabilitation therapy). The LEMS measures strength in five muscle groups bilaterally (hip flexors, knee flexors, extensors, and ankle dorsiflexors) and the UEMS also assess strength bilaterally in 5 muscle groups (elbow flexors, elbow extensors, wrist extensors, finger flexors, finger abductors) with the modified British Medical Research Council scale and is performed during the ISNCSCI examination.
Modified Ashworth Scale (MAS)
Time frame: changes within 6 months after participant enrolls.
Spasticity assessments will be performed at each visit using the MAS. It tests the resistance to passive movement about a joint with vary degrees of velocity. The scores range from 0 to 4, with 6 choices (0, 1, 1+, 2, 3, and 4). A score of 0 indicates no resistance, and 4 indicates rigidity. The MAS scores will be averaged across 5 muscle groups bilaterally for lower extremities and 5 muscle groups for upper extremities. An experienced therapist will perform all the evaluations for all the visits and all subjects.
Spinal Cord Independence measure III (SCIM III)
Time frame: changes within 6 months after participant enrolls.
The SCIM is a measure of functional ability developed specifically for individuals with SCI to evaluate their performance of activities of daily living and to make functional assessments of this population sensitive to change. SCIM scores a task higher in patients who accomplish it with less assistannce, aids, or medical compromise than other patients. The SCIM III to be adopted by the current study is composed of 19 items in 3 subscales: (a) self-care; (b) respiration and sphincter management; and (c) mobility. The total score ranges from 0 to 100. Mobility is subdivided into "room and toilet" and "indoors and outdoors". The items are weighted in terms of their assumed clinical relevance. The SCIM III is a valid and reliable measure and is recommended as a primary outcome measure to assess functional recovery in individuals with SCI.
1 secondary outcome
Diffusion Tensor Image
Time frame: before [baseline] and 2 weeks, 1 month, 3 months and 6 months after commencement of rehabilitative treatment)
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 Sep 2020.
- Background: PubMed 22330109Kirshblum SC, Waring W, Biering-Sorensen F, Burns SP, Johansen M, Schmidt-Read M, Donovan W, Graves D, Jha A, Jones L, Mulcahey MJ, Krassioukov A. Reference for the 2011 revision of the International Standards for Neurological Classification of Spinal Cord Injury. J Spinal Cord Med. 2011 Nov;34(6):547-54. doi: 10.1179/107902611X13186000420242.
- Background: PubMed 15520975Marino RJ, Graves DE. Metric properties of the ASIA motor score: subscales improve correlation with functional activities. Arch Phys Med Rehabil. 2004 Nov;85(11):1804-10. doi: 10.1016/j.apmr.2004.04.026.
- Background: PubMed 23608812Mulcahey MJ, Samdani AF, Gaughan JP, Barakat N, Faro S, Shah P, Betz RR, Mohamed FB. Diagnostic accuracy of diffusion tensor imaging for pediatric cervical spinal cord injury. Spinal Cord. 2013 Jul;51(7):532-7. doi: 10.1038/sc.2013.36. Epub 2013 Apr 23.
- Background: PubMed 20822462Chang Y, Jung TD, Yoo DS, Hyun JK. Diffusion tensor imaging and fiber tractography of patients with cervical spinal cord injury. J Neurotrauma. 2010 Nov;27(11):2033-40. doi: 10.1089/neu.2009.1265.
- Background: PubMed 21875333Cheran S, Shanmuganathan K, Zhuo J, Mirvis SE, Aarabi B, Alexander MT, Gullapalli RP. Correlation of MR diffusion tensor imaging parameters with ASIA motor scores in hemorrhagic and nonhemorrhagic acute spinal cord injury. J Neurotrauma. 2011 Sep;28(9):1881-92. doi: 10.1089/neu.2010.1741. Epub 2011 Aug 29.
- Background: PubMed 12482074Toma K, Matsuoka T, Immisch I, Mima T, Waldvogel D, Koshy B, Hanakawa T, Shill H, Hallett M. Generators of movement-related cortical potentials: fMRI-constrained EEG dipole source analysis. Neuroimage. 2002 Sep;17(1):161-73. doi: 10.1006/nimg.2002.1165.
- Background: PubMed 22730072Freund P, Curt A, Friston K, Thompson A. Tracking changes following spinal cord injury: insights from neuroimaging. Neuroscientist. 2013 Apr;19(2):116-28. doi: 10.1177/1073858412449192. Epub 2012 Jun 22.
- Background: PubMed 23770410Brennan FH, Cowin GJ, Kurniawan ND, Ruitenberg MJ. Longitudinal assessment of white matter pathology in the injured mouse spinal cord through ultra-high field (16.4 T) in vivo diffusion tensor imaging. Neuroimage. 2013 Nov 15;82:574-85. doi: 10.1016/j.neuroimage.2013.06.019. Epub 2013 Jun 14.
- Background: PubMed 23134591Keil C, Prell T, Peschel T, Hartung V, Dengler R, Grosskreutz J. Longitudinal diffusion tensor imaging in amyotrophic lateral sclerosis. BMC Neurosci. 2012 Nov 8;13:141. doi: 10.1186/1471-2202-13-141.
- Background: PubMed 17368446Mac Donald CL, Dikranian K, Song SK, Bayly PV, Holtzman DM, Brody DL. Detection of traumatic axonal injury with diffusion tensor imaging in a mouse model of traumatic brain injury. Exp Neurol. 2007 May;205(1):116-31. doi: 10.1016/j.expneurol.2007.01.035. Epub 2007 Feb 12.
- Background: PubMed 23758292Koskinen E, Brander A, Hakulinen U, Luoto T, Helminen M, Ylinen A, Ohman J. Assessing the state of chronic spinal cord injury using diffusion tensor imaging. J Neurotrauma. 2013 Sep 15;30(18):1587-95. doi: 10.1089/neu.2013.2943. Epub 2013 Aug 9.
- Background: PubMed 14143329ASHWORTH B. PRELIMINARY TRIAL OF CARISOPRODOL IN MULTIPLE SCLEROSIS. Practitioner. 1964 Apr;192:540-2. No abstract available.
- Individual participant dataSharing planned: No
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Spinal Cord Injuries, Traumatic Spinal Cord Injury
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Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
Spinal Cord Injury, Traumatic Spinal Cord Injury
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
RecruitingPhase 2
Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
Spinal Cord Injury, Spasticity
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.
Bing Yao, Ph.D. principal investigator
Kessler Fondation
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 Injuries, run by Kessler Foundation 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 6 inclusion and 7 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 Sep 2020. 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?
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) (time frame: changes within 6 months after participant enrolls.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03069222, which also lists 16 linked publications.
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 Sep 2020; AzTrials last refreshed its copy on 5 Nov 2026.