Spinal Cord InjuryNCT07073313
Using Muscle Functional MRI to Study Spatial Muscle Activation Patterns in People With SCI
An observational study of Spinal Cord Injury, run by Kessler Foundation.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- SCI group Inclusion criteria
- 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
Show all 12Show fewer
- Ability to flex and extend at least one knee joint under volitional control:
- without stimulation or assistance
- full range of motion not required
- ability to move against gravity not required Able bodied group Inclusion criteria
- Age: 18-50 yrs
- BMI <35 kg/m2
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
Several intervention modalities including locomotor training and neuromuscular stimulation have demonstrated the ability to promote neuromuscular recovery following both motor complete and motor incomplete spinal cord injury. While an array of methodologies and technologies exist for evaluating different aspects of recovery - for instance, stabilometry to assess balance and DEXA to assess bone mineral density - there remains a need for a means to comprehensively study spatial changes to muscle activation. Electromyography (EMG) provides temporal information for muscle firing during activity; however, it has several important limitations. While surface EMG (sEMG) is relatively easily collected, it cannot collect information on deep muscles and is susceptible to cross-talk - i.e. signals originating from muscles other than those intended to be studied. Fine wire intramuscular EMG is available but is invasive, and both sEMG and fine wire EMG suffer from reliability issues related to sensitivity to exact placement of electrodes and changes in skin conductivity.
In this project the investigators propose to investigate the potential for muscle functional MRI (mfMRI) techniques to study changes in spatial patterns of neuromuscular activation associated with spinal cord injury (SCI). mfMRI imaging focuses on the time for relaxation of transverse magnetization (T2) of water in muscle, which has been found to be increased, i.e. prolonged, with exercise of the muscle. The phenomenon is understood to be related to an accumulation of osmolytes (phosphate, lactate, and sodium) in the muscle water. In our literature search the investigators have not found reports of mfMRI used to observe differences in activation in people with SCI, nor in any other neurological population. For all imaging in our study, participants will perform supine quadriceps leg raise exercises on the detachable MRI table outside the scanner. They will then be transported into the MRI scan chamber for T2 scanning of the thigh muscles. Sessions will start with several minutes of rest and baseline imaging to collect resting state T2, with exercise related T2 shifts to be calculated relative to this. Segmentation of the four quadriceps muscles on each slice will be used to describe the overall activation of each muscle. The investigators will perform a cross sectional study comparing T2 shift muscle activation values between people with motor incomplete SCI and a control group without SCI. The investigators hypothesize that people with SCI will have lower T2 shift values and less uniform muscle activation than able bodied controls. Successful completion of this study will provide new information on spatial muscle activation patterns in SCI and produce knowledge to point the way to more widespread application of the technique.
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, muscle functional MRI
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline. The pattern will be observed one time in this single observation cross sectional study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Barrance, Kessler Foundation
- Investigators
- Peter Barrance, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073313
- Sponsor's protocol ID
- R-1295-25
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is no formal plan to share IPD with other researchers. The PI will cooperate with inquiries and share de-identified data and methodology details if requested.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Muscle Functional MRI to Study Spatial Muscle Activation Patterns in People With SCI
- ClinicalTrials.gov ID
- NCT07073313
- Acronym / sponsor ID
- R-1295-25
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, muscle functional MRI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 18 Jul 2025 (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.
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.
Detailed description
Several intervention modalities including locomotor training and neuromuscular stimulation have demonstrated the ability to promote neuromuscular recovery following both motor complete and motor incomplete spinal cord injury. While an array of methodologies and technologies exist for evaluating different aspects of recovery - for instance, stabilometry to assess balance and DEXA to assess bone mineral density - there remains a need for a means to comprehensively study spatial changes to muscle activation. Electromyography (EMG) provides temporal information for muscle firing during activity; however, it has several important limitations. While surface EMG (sEMG) is relatively easily collected, it cannot collect information on deep muscles and is susceptible to cross-talk - i.e. signals originating from muscles other than those intended to be studied. Fine wire intramuscular EMG is available but is invasive, and both sEMG and fine wire EMG suffer from reliability issues related to sensitivity to exact placement of electrodes and changes in skin conductivity.
In this project the investigators propose to investigate the potential for muscle functional MRI (mfMRI) techniques to study changes in spatial patterns of neuromuscular activation associated with spinal cord injury (SCI). mfMRI imaging focuses on the time for relaxation of transverse magnetization (T2) of water in muscle, which has been found to be increased, i.e. prolonged, with exercise of the muscle. The phenomenon is understood to be related to an accumulation of osmolytes (phosphate, lactate, and sodium) in the muscle water. In our literature search the investigators have not found reports of mfMRI used to observe differences in activation in people with SCI, nor in any other neurological population. For all imaging in our study, participants will perform supine quadriceps leg raise exercises on the detachable MRI table outside the scanner. They will then be transported into the MRI scan chamber for T2 scanning of the thigh muscles. Sessions will start with several minutes of rest and baseline imaging to collect resting state T2, with exercise related T2 shifts to be calculated relative to this. Segmentation of the four quadriceps muscles on each slice will be used to describe the overall activation of each muscle. The investigators will perform a cross sectional study comparing T2 shift muscle activation values between people with motor incomplete SCI and a control group without SCI. The investigators hypothesize that people with SCI will have lower T2 shift values and less uniform muscle activation than able bodied controls. Successful completion of this study will provide new information on spatial muscle activation patterns in SCI and produce knowledge to point the way to more widespread application of the technique.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (12 listed)
- SCI group Inclusion criteria
- 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
Key exclusion criteria (1 listed)
- -
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
Pattern of thigh muscle activation pattern during knee extension exercise
Time frame: Baseline. The pattern will be observed one time in this single observation cross sectional study.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Undecided. There is no formal plan to share IPD with other researchers. The PI will cooperate with inquiries and share de-identified data and methodology details if requested.
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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.
Peter Barrance, PhD principal investigator
Kessler Foundation
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by Kessler Foundation.
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 12 inclusion and 1 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: opening soon, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Barrance, PhD (973-324-3550, pbarrance@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of thigh muscle activation pattern during knee extension exercise (time frame: Baseline. The pattern will be observed one time in this single observation cross sectional study.). 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 26 Aug 2025.