ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhancing Recovery in Non-Traumatic Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03320759
Recruitment Status : Not yet recruiting
First Posted : October 25, 2017
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Western University, Canada

Brief Summary:

The investigators have spent the last decade uncovering unique metabolic and functional abnormalities in the brains of patients with spinal cord compression. Degenerative spinal cord compression represents a unique model of reversible spinal cord injury. In the investigator's previous work, they have demonstrated that cortical reorganization and recruitment is associated with metabolic changes in the brains of patients recovering from spinal cord compression and is correlated with recovery and improved neurological scores.

The goal of this study is to combine a rigorous platform of clinical care that includes preoperative evaluation, surgery, and rehabilitation, with state of the art imaging techniques to demonstrate how rehabilitative therapy can increase brain plasticity and recovery of neurological function in patients with spinal cord injury. Neurological function will be carefully evaluated in two groups of patients, those receiving rehabilitation and those not receiving rehabilitation after spine surgery, and will be correlated with the results of advanced imaging.


Condition or disease Intervention/treatment Phase
Spinal Cord Compression Spinal Cord Injuries Cervical Spondylosis Myelopathy Cervical Behavioral: Occupational therapy rehabilitation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Recovery in Non-Traumatic Spinal Cord Injury: Implementation of an Integrated Program for the Assessment of Rehabilitation Therapies
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No rehabilitation
Experimental: Rehabilitation Behavioral: Occupational therapy rehabilitation
Participants in the experimental arm will receive occupational therapy that is individualized to each participant's needs from week 4 post-decompression surgery until week 12.




Primary Outcome Measures :
  1. Changes in levels of N-acetylaspartate (NAA) in the motor cortex [ Time Frame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) ]
    It is expected that the group of patients receiving rehabilitation will experience less decline in NAA concentrations as compared to the second group of patients not receiving rehabilitation.

  2. Changes to volume of activation in motor and supplementary motor cortices [ Time Frame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) ]
    Volume of activation is measured by calculating the voxel number within our selected cortical regions, the motor cortex and supplementary motor cortex, using functional magnetic resonance imaging (fMRI). Changes in these numbers demonstrate volume of cortical activation changes in these regions. Following rehabilitation, the investigators expect that the volume of cortical activation of patients, expressed as voxel number, will change between time points compared with changes observed in the control group.

  3. Changes in Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) scores [ Time Frame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) ]
    Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) is an indicator of dorsal and palmar sensation, strength (by myotome) and prehension (grasping). GRASSP is a standardized measure to assess hand function in ways that are meaningful in the context of a patient's overall ability to complete activities of daily living.

  4. Changes to intensity of cortical activation in motor and supplementary motor cortices [ Time Frame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) ]
    Intensity of cortical activation is expressed as signal intensity in beta weights. Following rehabilitation, the investigators expect that the intensity of cortical activation in participants in the intervention group will change between time-points compared with changes observed in the control group.


Secondary Outcome Measures :
  1. RAND Short form (SF)-36 Health Survey Questionnaire [ Time Frame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months)] ]
    General health status self-administered evaluation tool. Better scores in the intervention group are expected. Composite score will be reported. The range for this score is from 0 to 100, with 100 indicating the best general health status possible. Subscale scores also range from 0-100 and are simply an average of the scores for each of their relevant questions. Subscales are combined into a composite score by averaging results of all subscales, which is the methodology specified by the creators of the scale (RAND).

  2. Modified Japanese Orthopaedic Association (mJOA) scale [ Time Frame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) ]
    A clinical tool used to evaluate impairment due to cervical spondylotic myelopathy, including loss of sensation, motor abilities in limbs, and bowel and bladder control. The lowest possible score is a 0 and the highest, 18. Higher numbers indicate better functioning. Item scores are simply summed to arrive at the composite score.

  3. Myelopathy Disability Index (MDI) [ Time Frame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) ]
    This self-administered questionnaire is used to measure the degree to which myelopathy has affected the participant's ability to perform activities of daily living. Raw scores will be calculated for each participant and may range from 0 to 30. To arrive at the participant's raw score, item scores are simply summed. The final scores used for analysis will be the participant's score expressed as a percentage. Higher scores indicate greater impairment.

  4. American Spinal Injury Association (ASIA) Impairment Scale [ Time Frame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) ]
    A clinical assessment tool used to classify motor and sensory impairment in persons with myelopathy. Subscales to be reported include the right and left motor scores (range=0-50 for both) and the right and left sensory scores (range=0-60 for both). Higher scores indicate less impairment.

  5. Strength as tested with hand dynamometer [ Time Frame: Measured and reported for all follow-ups throughout study (i.e. pre-operatively, 4 weeks, 6 weeks, 6 months) ]
    A device used to measure grip strength.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • right-handed
  • have a history of progressive neurological deficits <24 months
  • eligible for MRI scanning

Exclusion Criteria:

  • having any other neurological disorder or systemic disease that can impair neurological function
  • not fluent in reading and speaking English
  • being claustrophobic
  • unable to follow simple task instructions and maintain standardized movements
  • being unable to return for all follow-up imaging and rehabilitation sessions

Responsible Party: Western University, Canada
ClinicalTrials.gov Identifier: NCT03320759     History of Changes
Other Study ID Numbers: 108706
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Spondylosis
Spinal Cord Compression
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases