NCT07073313

Brief Summary

Several types of treatment and therapy have been shown to promote improvements in movement and other health gains in people with spinal cord injury (SCI). Researchers use many different methods to measure these gains- for instance they measure their ability to stand and walk and use scanning technologies to measure bone loss and recovery. They also often use a technique known as electromyography (EMG), which detects electrical signals coming from muscles, to measure how well the muscles are being activated. While EMG has many advantages, it also has some important limitations. For instance, it is difficult to gather information from muscles below the surface, and the results can change significantly if the sensing electrodes are moved only slightly, making it harder to measure differences across different testing sessions. In this project, the investigators will use another technique to study muscle activations in people with SCI. This technique, known as muscle functional MRI (mfMRI), uses MRI scanning to measure the activation of muscles. One of the signals that MRI imaging uses has been found to change with exercise; this change is understood to be related to a buildup of chemicals in the water inside the muscle. MRI scanning has many variable settings, or parameters, that can be changed to pick up specific signals, and our team has developed a set of settings (also known as an MRI sequence) that is specially adapted to measure the mfMRI signal. Although other groups have used mfMRI to study muscle activation in other groups of people and other activities, the investigators do not believe there have been any previous studies in people with SCI. Participants in our study will lie on their back with their knee raised on a bolster and raise the lower part of their leg to straighten the knee, for several repetitions. They will do this in a room outside the MRI scanner, on a table that can be attached to the scanner for imaging. After they finish exercising, they will be moved into the MRI scan room for mfMRI scanning of the muscles of the thigh. The four muscles of the quadriceps that straighten the knee will be studied, with specialized data processing used to measure the overall activation of each of the muscles. The investigators will compare mfMRI values between people with SCI and a control group of able bodied people. These people will have motor incomplete SCI, meaning that they still have some ability to move their body in regions below the injury. By completing this study the investigators will provide new information on spatial muscle activation patterns, and they expect that this will lead the way to more widespread application of the technique in the future.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started Sep 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

May 29, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

August 26, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

May 29, 2025

Last Update Submit

August 19, 2025

Conditions

Keywords

Spinal Cord Injurymuscle functional MRI

Outcome Measures

Primary Outcomes (1)

  • Pattern of thigh muscle activation pattern during knee extension exercise

    T2 relaxation time values will be observed for regions of interest (ROI) for four muscles at three levels in the thigh. The T2 shift in milliseconds for each ROI will be calculated by subtracting the resting value from the value following the exercise. Hence, a T2 shift will be calculated for every muscle and imaging level. The activation pattern will be the 4x3 (muscle x level) matrix of proportions of each shift to the shifts summed across all (4x3=12) observations. In this way, the pattern represents the qualitative proportion of activation spatially across the considered muscles, and controls for differences in task performance.

    Baseline. The pattern will be observed one time in this single observation cross sectional study.

Study Arms (2)

Motor incomplete Spinal Cord Injury

Chronic (\>1yr) incomplete motor and sensory Spinal Cord Injury

Able bodied control

Able bodied people with no history of lower extremity injury or gait deviation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

SCI group Exclusion criteria * Spasticity/clonus: Individuals with uncontrolled spasticity of clonus that would interfere with scanning procedures will be excluded * MRI contraindications including: * Possibility of pregnancy\* * Implanted cardiac pacemaker * Cochlear implants * Aneurysm clip * Ocular metal body (e.g. metal shavings in the eye) * Shrapnel or bullet fragments near vital structures * Implanted defibrillators AB group Exclusion criteria * MRI contraindications including the possibility of pregnancy as listed above * History of injury to the dominant lower extremity * Any clinically significant gait deviation * Known factors elevating risk for stroke or heart attack during exercise

You may qualify if:

  • Age: 18-50 yrs
  • BMI \<35 kg/m2
  • Chronic injury (at least 1 year post injury)
  • Neurological injury status: Incomplete motor and sensory SCI classified with ASIA Impairment Scale C or D
  • Ambulatory status: Participants must be nonambulatory. Individuals who can stand or walk even a few steps with or without assistance will not be eligible to participate
  • Ability to flex and extend at least one knee joint under volitional control:
  • without stimulation or assistance
  • full range of motion not required
  • Age: 18-50 yrs
  • BMI \<35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Peter Barrance, PhD

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

May 29, 2025

First Posted

July 18, 2025

Study Start

September 1, 2025

Primary Completion

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

August 26, 2025

Record last verified: 2025-05