Longitudinal Assessment of Spinal Cord Structural Plasticity Using DTI in SCI Patients

NCT03069222 | Completed

• 1 other identifier: Kessler
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinal Cord Injuries

Keywords

diffusion tensor imaging

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  changes within 6 months after participant enrolls.

Secondary Outcomes (1)

• Diffusion Tensor Image

  before [baseline] and 2 weeks, 1 month, 3 months and 6 months after commencement of rehabilitative treatment)

Study Arms (2)

Patient

SCI patients enrolled at Kessler Institute Rehabiliation

Other: Standard Rehabilitative Treatment

Control

age and gender matched with patient enrolled

Interventions

Standard Rehabilitative Treatment OTHER

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.

Patient

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Related Publications (16)

• 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.

  PMID: 22330109 BACKGROUND

• Marino 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.

  PMID: 15520975 BACKGROUND

• Mulcahey 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.

  PMID: 23608812 BACKGROUND

• Chang 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.

  PMID: 20822462 BACKGROUND

• Cheran 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.

  PMID: 21875333 BACKGROUND

• Toma 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.

  PMID: 12482074 BACKGROUND

• Freund 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.

  PMID: 22730072 BACKGROUND

• Brennan 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.

  PMID: 23770410 BACKGROUND

• Keil 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.

  PMID: 23134591 BACKGROUND

• Mac 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.

  PMID: 17368446 BACKGROUND

• Koskinen 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.

  PMID: 23758292 BACKGROUND

• ASHWORTH B. PRELIMINARY TRIAL OF CARISOPRODOL IN MULTIPLE SCLEROSIS. Practitioner. 1964 Apr;192:540-2. No abstract available.

  PMID: 14143329 BACKGROUND

• Kirshblum 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.

  PMID: 15520976 BACKGROUND

• Anderson 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.

  PMID: 18581660 BACKGROUND

• Catz 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.

  PMID: 16909143 BACKGROUND

• Anderson KD, Acuff ME, Arp BG, Backus D, Chun S, Fisher K, Fjerstad JE, Graves DE, Greenwald K, Groah SL, Harkema SJ, Horton JA 3rd, Huang MN, Jennings M, Kelley KS, Kessler SM, Kirshblum S, Koltenuk S, Linke M, Ljungberg I, Nagy J, Nicolini L, Roach MJ, Salles S, Scelza WM, Read MS, Reeves RK, Scott MD, Tansey KE, Theis JL, Tolfo CZ, Whitney M, Williams CD, Winter CM, Zanca JM. United States (US) multi-center study to assess the validity and reliability of the Spinal Cord Independence Measure (SCIM III). Spinal Cord. 2011 Aug;49(8):880-5. doi: 10.1038/sc.2011.20. Epub 2011 Mar 29.

  PMID: 21445081 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Bing Yao, Ph.D.

  Kessler Fondation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physicist and Manager

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: March 3, 2017
• Study Start: April 1, 2016
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)