Spinal Cord InjuriesNCT03854214
Investigation of Brain Functional MRI as an Early Biomarker of Recovery in Individuals With Spinal Cord Injury
A study testing Functional Electric Stimulation cycling and Passive cycling in people with Spinal Cord Injuries, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial summary
Early detection of response to therapeutic intervention is vital, as it will enable early termination of intervention in non-responding patients, prevent unnecessary financial burden, and allow for early changes to the intervention program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Functional Electric Stimulation cycling and Passive cycling
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18-65 years) men and women of all ethnic groups
- SCI, traumatic
- Thoracic neurological level, without the involvement of lower motor neurons.
- American Spinal Injury Association (ASIA) classification A-D
- Chronic injury: > 6 months from the injury
- Satisfactory general health
- No FES ergometer (i.e. RT300 or equivalent) use within 4 weeks.
- Ability to comply with procedures and follow-up
Who cannot join
- Contra-indication to Magnetic Resonance (MR) study (e.g., cardiac pacemaker, claustrophobia, aneurysm clip, etc.)
- History or clinical evidence of moderate or severe brain injury
- Major spine deformity (e.g. scoliosis, kyphosis, subluxation)
- Movement disorder or severe spasticity preventing ability to lay still for extended periods required for imaging.
- Women who are pregnant
- Concurrent lower motor neuron disease such as peripheral neuropathy that would exclude lower extremity electrical excitability
- Unstable long bone fractures of the lower extremities.
- Subjects with history of inability to tolerate electrical stimulation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute, International Center for Spinal Cord Injury
Baltimore, Maryland, 21205
About this study
Official title: Cortical Functional Connectivity as an Early Biomarker of Recovery in Spinal Cord Injury (Study 239481)
Early detection of response to therapeutic intervention is vital, as it will enable early termination of intervention in non-responding patients, prevent unnecessary financial burden, and allow for early changes to the intervention program. Previous functional MRI (fMRI) studies have shown that changes in brain functional network in spinal cord injury (SCI) patients can occur after as little as one week of intervention. Resting state fMRI (rsfMRI) is a type of fMRI that does not require performance of explicit motor tasks, which makes the method especially suitable for SCI patient population. In this project, the investigators propose that rsfMRI outcome measures can be used to detect early brain functional network changes that occur during intervention, and that the changes will be predictive of recovery in chronic SCI patients.
Read the detailed description
Early detection of response to spinal cord injury (SCI) therapeutic intervention programs is vital, as it will enable early termination of intervention in non-responding patients, prevent unnecessary financial burden, and allow for early changes of the programs. In this project, the investigators propose that resting state functional MRI (rsfMRI) can be used to detect early brain functional network changes that occur during intervention, and that the changes will be predictive of recovery in chronic SCI patients. The long-term goal of this study is to establish rsfMRI as a new imaging biomarker that is predictive of progress towards recovery in response to therapy. International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) scoring system is the most widely used clinical classification system of SCI that describes neurological injury level and degree of functional preservation. It is also used to monitor the progress and response to interventions such as functional electrical stimulation (FES) therapy. However, monitoring responses using ISNCSCI is challenging, because its ability to describe the degree of functional loss is limited. Therefore, there is a need in the field of SCI for a biomarker that is more sensitive to changes in function. The investigators will recruit 2 groups of 24 chronic SCI patients. In one group, the investigators will characterize the baseline time profile of rsfMRI outcome measures acquired during a 4-weeks passive cycling program, where movement is driven only by the cycle's motor (no electric stimulation). RsfMRI data of the patients acquired at weeks 0, 2, and 4 will be used perform functional parcellation of the sensorimotor cortex using independent component analysis (ICA) and spectral clustering analysis (SCA) approaches. BNC will be calculated between pairs of sensory and motor brain parcels. Sensory and motor ISNCSCI scores will also be measured at weeks 0, 2, and 4. The investigators will then test the hypothesis that the investigators will observe stable baseline measures of sensory and motor cortex BNC and ISNCSCI scores of the patients during the 4-week passive cycling program, with minimal to no change in values. In the second group, the investigators will characterize the time profile of the cortical reorganization in chronic SCI patients that occurs during the four-week FES cycling. Specifically, the investigators predict that the investigators will observe early functional network changes in the sensorimotor cortex of SCI patients (measured using BNC) at week 2 of the four-week FES cycling program, which will be predictive of changes in ISNCSCI scores (neurological outcomes) at week 4. Finally, the longitudinal intra-subject reproducibility of the two parcellation methods will be investigated. If successful, the study will: 1) provide a new and effective clinical tool to study plastic cortical changes that occur after SCI, 2) provide a new non-invasive imaging biomarker that is predictive of progress towards recovery in response to therapy, and 3) extend our knowledge about the functional reorganization that takes place during and after therapeutic intervention.
- Conditions
- Spinal Cord Injuries
- Being tested
- Functional Electric Stimulation cycling, Passive cycling
- Keywords
- Spinal Cord Injuries, MRI, Functional, Rehabilitation, Neuronal Plasticity
- 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.
Functional Electric Stimulation cyclingDevice
Also called RT300 ergometer
The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 revolutions per minute (RPM). Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week.
Passive cyclingDevice
Also called RT300 ergometer
The passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment.
| Study group | Role | What they receive |
|---|---|---|
| Functional Electric Stimulation cycling | Active comparator | The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc) with stimulation on. Receives: Device: Functional Electric Stimulation cycling |
| Passive Cycling | Sham comparator | The passive cycling group will use the same RT300 ergometer with stimulation off. Receives: Device: Passive cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) Score
Developed by the American Spinal Injury Association (ASIA), the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) provides an overall assessment of motor and sensory function following spinal cord injury. For this study, a single composite ISNCSCI score is reported, which ranges from 0 (indicating the worst overall function) to 324 (indicating normal overall function). The data table presents this composite score as the sole outcome measure for each Arm/Group.
Measured: Baseline
International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) Score
Developed by the American Spinal Injury Association (ASIA), the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) provides an overall assessment of motor and sensory function following spinal cord injury. For this study, a single composite ISNCSCI score is reported, which ranges from 0 (indicating the worst overall function) to 324 (indicating normal overall function). The data table presents this composite score as the sole outcome measure for each Arm/Group.
Measured: 2 weeks
International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) Score
Developed by the American Spinal Injury Association (ASIA), the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) provides an overall assessment of motor and sensory function following spinal cord injury. For this study, a single composite ISNCSCI score is reported, which ranges from 0 (indicating the worst overall function) to 324 (indicating normal overall function). The data table presents this composite score as the sole outcome measure for each Arm/Group.
Measured: 4 weeks
Resting State fMRI Functional Connectivity
Resting state functional magnetic resonance imaging (RsfMRI) functional connectivity is defined as the temporal dependency of neuronal activation patterns (represented by the blood oxygenation level dependent (BOLD) signal time courses as measured using rsfMRI) of anatomically separated brain regions. There are number of methodologies one can use to characterize the degree and type of rsfMRI functional connectivity. One example is between-network-connectivity (BNC), which is defined as the degree of correlation between two time courses obtained from a pair of brain regions. Summary statistics of BNC (e.g., mean, variance), as well as the dynamic properties of BNC (e.g., dynamic functional connectivity) can be used to further summarize the characteristics of the functional connectivity in SCI population. Note that the BNC values reported in the Outcome Measure data table represent "Pearson's Correlation Coefficient" and not z-transformed Pearson's Correlation Coefficients.
Measured: Baseline
Resting State fMRI Functional Connectivity
RsfMRI functional connectivity is defined as the temporal dependency of neuronal activation patterns (represented by the blood oxygenation level dependent (BOLD) signal time courses as measured using rsfMRI) of anatomically separated brain regions. There are number of methodologies one can use to characterize the degree and type of rsfMRI functional connectivity. One example is between-network-connectivity (BNC), which is defined as the degree of correlation between two time courses obtained from a pair of brain regions. Summary statistics of BNC (e.g., mean, variance), as well as the dynamic properties of BNC (e.g., dynamic functional connectivity) can be used to further summarize the characteristics of the functional connectivity in SCI population. Note that the BNC values reported in the Outcome Measure data table represent "Pearson's Correlation Coefficient" and not z-transformed Pearson's Correlation Coefficients.
Measured: 2 weeks
Resting State fMRI Functional Connectivity
RsfMRI functional connectivity is defined as the temporal dependency of neuronal activation patterns (represented by the blood oxygenation level dependent (BOLD) signal time courses as measured using rsfMRI) of anatomically separated brain regions. There are number of methodologies one can use to characterize the degree and type of rsfMRI functional connectivity. One example is between-network-connectivity (BNC), which is defined as the degree of correlation between two time courses obtained from a pair of brain regions. Summary statistics of BNC (e.g., mean, variance), as well as the dynamic properties of BNC (e.g., dynamic functional connectivity) can be used to further summarize the characteristics of the functional connectivity in SCI population. Note that the BNC values reported in the Outcome Measure data table represent "Pearson's Correlation Coefficient" and not z-transformed Pearson's Correlation Coefficients.
Measured: 4 weeks
Resting-State fMRI Brain Parcels Outcome Measure: Sensorimotor Network (SMN) Recruitment Coefficient
Resting-state functional connectivity can also identify functionally homogeneous brain regions, or "parcels." By examining each parcel's properties, such as the center of mass and recruitment coefficient value, we can gain insights into the brain's functional reorganization. Given its importance in the SCI population, we focused on the sensorimotor network (SMN) parcel.
RsfMRI data were collected and preprocessed. The brain data was then parcellated into 200 parcels. Next, a multi-layer community detection algorithm was applied to identify cohesive subnetworks over time, and the SMN Recruitment Coefficient was calculated - which is a dimensionless metric that quantifies how strongly the SMN parcels cohere, or preferentially connect, with one another compared to parcels in other networks. Higher values suggest a more internally cohesive SMN, indicating stronger functional segregation and potentially more intact sensorimotor function.
Measured: Baseline
Resting-State fMRI Brain Parcels Outcome Measure: Sensorimotor Network (SMN) Recruitment Coefficient
Resting-state functional connectivity can also identify functionally homogeneous brain regions, or "parcels." By examining each parcel's properties, such as the center of mass and recruitment coefficient value, we can gain insights into the brain's functional reorganization. Given its importance in the SCI population, we focused on the sensorimotor network (SMN) parcel.
RsfMRI data were collected and preprocessed. The brain data was then parcellated into 200 parcels. Next, a multi-layer community detection algorithm was applied to identify cohesive subnetworks over time, and the SMN Recruitment Coefficient was calculated - which is a dimensionless metric that quantifies how strongly the SMN parcels cohere, or preferentially connect, with one another compared to parcels in other networks. Higher values suggest a more internally cohesive SMN, indicating stronger functional segregation and potentially more intact sensorimotor function.
Measured: 2 weeks
Resting-State fMRI Brain Parcels Outcome Measure: Sensorimotor Network (SMN) Recruitment Coefficient
Resting-state functional connectivity can also identify functionally homogeneous brain regions, or "parcels." By examining each parcel's properties, such as the center of mass and recruitment coefficient value, we can gain insights into the brain's functional reorganization. Given its importance in the SCI population, we focused on the sensorimotor network (SMN) parcel.
RsfMRI data were collected and preprocessed. The brain data was then parcellated into 200 parcels. Next, a multi-layer community detection algorithm was applied to identify cohesive subnetworks over time, and the SMN Recruitment Coefficient was calculated - which is a dimensionless metric that quantifies how strongly the SMN parcels cohere, or preferentially connect, with one another compared to parcels in other networks. Higher values suggest a more internally cohesive SMN, indicating stronger functional segregation and potentially more intact sensorimotor function.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be performed as a randomized, parallel group trial to determine if the amount of changes in brain functional connectivity outcome measures (i.e., between network connectivity) is significantly different between the group of patients that perform FES cycling and another group of patients that perform passive (sham) cycling. Official screening will be performed after participants consent by signing the study's consent form. Participants will be randomized into 2 groups: FES cycling (Group 1; n=24) and passive cycling (Group 2; n=24). The participants will undergo either an FES cycling or a passive cycling sessions for 4 weeks, 3 times a week. MRI will be performed on all participants at the beginning (prior to cycling sessions) and at the end of the 2nd and 4th weeks of the intervention program. ISNCSCI evaluations will be performed to coincide with the dates of MRI acquisitions, to determine the neurological level and the degree of sensory and motor impairments.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Choe, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Ann S Choe, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854214
- Sponsor's protocol ID
- 00182576
- Other IDs
- R21NS104644
- Status last verified
- Feb 2025
- First submitted
- 22 Jan 2019
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All research material will be kept confidential and any means of subject identification (name and history number) will be removed from all material for analysis or presentation. No identifying information will be made publicly available. In some cases, the study protocol, statistical analysis plan, individual scans, and all Individual Participant Data (IPD) that underlie results in a publication will be included in published papers or meeting papers or posters, but the identity of the subject in question will not be revealed.
Publications
Choe AS. Advances in Spinal Functional Magnetic Resonance Imaging in the Healthy and Injured Spinal Cords. Curr Phys Med Rehabil Rep. 2017 Sep;5(3):143-150. doi: 10.1007/s40141-017-0161-x. Epub 2017 Jul 31.
PubMed 29255645Choe AS, Nebel MB, Barber AD, Cohen JR, Xu Y, Pekar JJ, Caffo B, Lindquist MA. Comparing test-retest reliability of dynamic functional connectivity methods. Neuroimage. 2017 Sep;158:155-175. doi: 10.1016/j.neuroimage.2017.07.005. Epub 2017 Jul 5.
PubMed 28687517Choe AS, Jones CK, Joel SE, Muschelli J, Belegu V, Caffo BS, Lindquist MA, van Zijl PC, Pekar JJ. Reproducibility and Temporal Structure in Weekly Resting-State fMRI over a Period of 3.5 Years. PLoS One. 2015 Oct 30;10(10):e0140134. doi: 10.1371/journal.pone.0140134. eCollection 2015.
PubMed 26517540Choe AS, Belegu V, Yoshida S, Joel S, Sadowsky CL, Smith SA, van Zijl PC, Pekar JJ, McDonald JW. Extensive neurological recovery from a complete spinal cord injury: a case report and hypothesis on the role of cortical plasticity. Front Hum Neurosci. 2013 Jun 25;7:290. doi: 10.3389/fnhum.2013.00290. eCollection 2013.
PubMed 23805087
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Functional Connectivity as an Early Biomarker of Recovery in Spinal Cord Injury (Study 239481)
- ClinicalTrials.gov ID
- NCT03854214
- Acronym / sponsor ID
- 00182576
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, MRI, Functional, Rehabilitation, Neuronal Plasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Posted 10 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early detection of response to therapeutic intervention is vital, as it will enable early termination of intervention in non-responding patients, prevent unnecessary financial burden, and allow for early changes to the intervention program. Previous functional MRI (fMRI) studies have shown that changes in brain functional network in spinal cord injury (SCI) patients can occur after as little as one week of intervention. Resting state fMRI (rsfMRI) is a type of fMRI that does not require performance of explicit motor tasks, which makes the method especially suitable for SCI patient population. In this project, the investigators propose that rsfMRI outcome measures can be used to detect early brain functional network changes that occur during intervention, and that the changes will be predictive of recovery in chronic SCI patients.
Detailed description
Early detection of response to spinal cord injury (SCI) therapeutic intervention programs is vital, as it will enable early termination of intervention in non-responding patients, prevent unnecessary financial burden, and allow for early changes of the programs. In this project, the investigators propose that resting state functional MRI (rsfMRI) can be used to detect early brain functional network changes that occur during intervention, and that the changes will be predictive of recovery in chronic SCI patients. The long-term goal of this study is to establish rsfMRI as a new imaging biomarker that is predictive of progress towards recovery in response to therapy. International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) scoring system is the most widely used clinical classification system of SCI that describes neurological injury level and degree of functional preservation. It is also used to monitor the progress and response to interventions such as functional electrical stimulation (FES) therapy. However, monitoring responses using ISNCSCI is challenging, because its ability to describe the degree of functional loss is limited. Therefore, there is a need in the field of SCI for a biomarker that is more sensitive to changes in function. The investigators will recruit 2 groups of 24 chronic SCI patients. In one group, the investigators will characterize the baseline time profile of rsfMRI outcome measures acquired during a 4-weeks passive cycling program, where movement is driven only by the cycle's motor (no electric stimulation). RsfMRI data of the patients acquired at weeks 0, 2, and 4 will be used perform functional parcellation of the sensorimotor cortex using independent component analysis (ICA) and spectral clustering analysis (SCA) approaches. BNC will be calculated between pairs of sensory and motor brain parcels. Sensory and motor ISNCSCI scores will also be measured at weeks 0, 2, and 4. The investigators will then test the hypothesis that the investigators will observe stable baseline measures of sensory and motor cortex BNC and ISNCSCI scores of the patients during the 4-week passive cycling program, with minimal to no change in values. In the second group, the investigators will characterize the time profile of the cortical reorganization in chronic SCI patients that occurs during the four-week FES cycling. Specifically, the investigators predict that the investigators will observe early functional network changes in the sensorimotor cortex of SCI patients (measured using BNC) at week 2 of the four-week FES cycling program, which will be predictive of changes in ISNCSCI scores (neurological outcomes) at week 4. Finally, the longitudinal intra-subject reproducibility of the two parcellation methods will be investigated. If successful, the study will: 1) provide a new and effective clinical tool to study plastic cortical changes that occur after SCI, 2) provide a new non-invasive imaging biomarker that is predictive of progress towards recovery in response to therapy, and 3) extend our knowledge about the functional reorganization that takes place during and after therapeutic intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The study will be performed as a randomized, parallel group trial to determine if the amount of changes in brain functional connectivity outcome measures (i.e., between network connectivity) is significantly different between the group of patients that perform FES cycling and another group of patients that perform passive (sham) cycling. Official screening will be performed after participants consent by signing the study's consent form. Participants will be randomized into 2 groups: FES cycling (Group 1; n=24) and passive cycling (Group 2; n=24). The participants will undergo either an FES cycling or a passive cycling sessions for 4 weeks, 3 times a week. MRI will be performed on all participants at the beginning (prior to cycling sessions) and at the end of the 2nd and 4th weeks of the intervention program. ISNCSCI evaluations will be performed to coincide with the dates of MRI acquisitions, to determine the neurological level and the degree of sensory and motor impairments.
| Arm | Type | Receives |
|---|---|---|
| Functional Electric Stimulation cycling | Active comparator | Device: Functional Electric Stimulation cyclingThe Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc) with stimulation on. |
| Passive Cycling | Sham comparator | Device: Passive cyclingThe passive cycling group will use the same RT300 ergometer with stimulation off. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult (18-65 years) men and women of all ethnic groups
- SCI, traumatic
- Thoracic neurological level, without the involvement of lower motor neurons.
- American Spinal Injury Association (ASIA) classification A-D
- Chronic injury: > 6 months from the injury
Key exclusion criteria (8 listed)
- Contra-indication to Magnetic Resonance (MR) study (e.g., cardiac pacemaker, claustrophobia, aneurysm clip, etc.)
- History or clinical evidence of moderate or severe brain injury
- Major spine deformity (e.g. scoliosis, kyphosis, subluxation)
- Movement disorder or severe spasticity preventing ability to lay still for extended periods required for imaging.
- Women who are pregnant
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 |
|---|---|---|
| Functional Electric Stimulation cyclingAlso: RT300 ergometerThe Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 revolutions per minute (RPM). Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week. | Device | Functional Electric Stimulation cycling |
| Passive cyclingAlso: RT300 ergometerThe passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment. | Device | Passive Cycling |
Primary outcome
International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) Score
Time frame: Baseline
Developed by the American Spinal Injury Association (ASIA), the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) provides an overall assessment of motor and sensory function following spinal cord injury. For this study, a single composite ISNCSCI score is reported, which ranges from 0 (indicating the worst overall function) to 324 (indicating normal overall function). The data table presents this composite score as the sole outcome measure for each Arm/Group.
International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) Score
Time frame: 2 weeks
Developed by the American Spinal Injury Association (ASIA), the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) provides an overall assessment of motor and sensory function following spinal cord injury. For this study, a single composite ISNCSCI score is reported, which ranges from 0 (indicating the worst overall function) to 324 (indicating normal overall function). The data table presents this composite score as the sole outcome measure for each Arm/Group.
International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) Score
Time frame: 4 weeks
Developed by the American Spinal Injury Association (ASIA), the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) provides an overall assessment of motor and sensory function following spinal cord injury. For this study, a single composite ISNCSCI score is reported, which ranges from 0 (indicating the worst overall function) to 324 (indicating normal overall function). The data table presents this composite score as the sole outcome measure for each Arm/Group.
Resting State fMRI Functional Connectivity
Time frame: Baseline
Resting state functional magnetic resonance imaging (RsfMRI) functional connectivity is defined as the temporal dependency of neuronal activation patterns (represented by the blood oxygenation level dependent (BOLD) signal time courses as measured using rsfMRI) of anatomically separated brain regions. There are number of methodologies one can use to characterize the degree and type of rsfMRI functional connectivity. One example is between-network-connectivity (BNC), which is defined as the degree of correlation between two time courses obtained from a pair of brain regions. Summary statistics of BNC (e.g., mean, variance), as well as the dynamic properties of BNC (e.g., dynamic functional connectivity) can be used to further summarize the characteristics of the functional connectivity in SCI population. Note that the BNC values reported in the Outcome Measure data table represent "Pearson's Correlation Coefficient" and not z-transformed Pearson's Correlation Coefficients.
Resting State fMRI Functional Connectivity
Time frame: 2 weeks
RsfMRI functional connectivity is defined as the temporal dependency of neuronal activation patterns (represented by the blood oxygenation level dependent (BOLD) signal time courses as measured using rsfMRI) of anatomically separated brain regions. There are number of methodologies one can use to characterize the degree and type of rsfMRI functional connectivity. One example is between-network-connectivity (BNC), which is defined as the degree of correlation between two time courses obtained from a pair of brain regions. Summary statistics of BNC (e.g., mean, variance), as well as the dynamic properties of BNC (e.g., dynamic functional connectivity) can be used to further summarize the characteristics of the functional connectivity in SCI population. Note that the BNC values reported in the Outcome Measure data table represent "Pearson's Correlation Coefficient" and not z-transformed Pearson's Correlation Coefficients.
Resting State fMRI Functional Connectivity
Time frame: 4 weeks
RsfMRI functional connectivity is defined as the temporal dependency of neuronal activation patterns (represented by the blood oxygenation level dependent (BOLD) signal time courses as measured using rsfMRI) of anatomically separated brain regions. There are number of methodologies one can use to characterize the degree and type of rsfMRI functional connectivity. One example is between-network-connectivity (BNC), which is defined as the degree of correlation between two time courses obtained from a pair of brain regions. Summary statistics of BNC (e.g., mean, variance), as well as the dynamic properties of BNC (e.g., dynamic functional connectivity) can be used to further summarize the characteristics of the functional connectivity in SCI population. Note that the BNC values reported in the Outcome Measure data table represent "Pearson's Correlation Coefficient" and not z-transformed Pearson's Correlation Coefficients.
Resting-State fMRI Brain Parcels Outcome Measure: Sensorimotor Network (SMN) Recruitment Coefficient
Time frame: Baseline
Resting-state functional connectivity can also identify functionally homogeneous brain regions, or "parcels." By examining each parcel's properties, such as the center of mass and recruitment coefficient value, we can gain insights into the brain's functional reorganization. Given its importance in the SCI population, we focused on the sensorimotor network (SMN) parcel. RsfMRI data were collected and preprocessed. The brain data was then parcellated into 200 parcels. Next, a multi-layer community detection algorithm was applied to identify cohesive subnetworks over time, and the SMN Recruitment Coefficient was calculated - which is a dimensionless metric that quantifies how strongly the SMN parcels cohere, or preferentially connect, with one another compared to parcels in other networks. Higher values suggest a more internally cohesive SMN, indicating stronger functional segregation and potentially more intact sensorimotor function.
Resting-State fMRI Brain Parcels Outcome Measure: Sensorimotor Network (SMN) Recruitment Coefficient
Time frame: 2 weeks
Resting-state functional connectivity can also identify functionally homogeneous brain regions, or "parcels." By examining each parcel's properties, such as the center of mass and recruitment coefficient value, we can gain insights into the brain's functional reorganization. Given its importance in the SCI population, we focused on the sensorimotor network (SMN) parcel. RsfMRI data were collected and preprocessed. The brain data was then parcellated into 200 parcels. Next, a multi-layer community detection algorithm was applied to identify cohesive subnetworks over time, and the SMN Recruitment Coefficient was calculated - which is a dimensionless metric that quantifies how strongly the SMN parcels cohere, or preferentially connect, with one another compared to parcels in other networks. Higher values suggest a more internally cohesive SMN, indicating stronger functional segregation and potentially more intact sensorimotor function.
Resting-State fMRI Brain Parcels Outcome Measure: Sensorimotor Network (SMN) Recruitment Coefficient
Time frame: 4 weeks
Resting-state functional connectivity can also identify functionally homogeneous brain regions, or "parcels." By examining each parcel's properties, such as the center of mass and recruitment coefficient value, we can gain insights into the brain's functional reorganization. Given its importance in the SCI population, we focused on the sensorimotor network (SMN) parcel. RsfMRI data were collected and preprocessed. The brain data was then parcellated into 200 parcels. Next, a multi-layer community detection algorithm was applied to identify cohesive subnetworks over time, and the SMN Recruitment Coefficient was calculated - which is a dimensionless metric that quantifies how strongly the SMN parcels cohere, or preferentially connect, with one another compared to parcels in other networks. Higher values suggest a more internally cohesive SMN, indicating stronger functional segregation and potentially more intact sensorimotor function.
Results and safety
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Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29255645Choe AS. Advances in Spinal Functional Magnetic Resonance Imaging in the Healthy and Injured Spinal Cords. Curr Phys Med Rehabil Rep. 2017 Sep;5(3):143-150. doi: 10.1007/s40141-017-0161-x. Epub 2017 Jul 31.
- Background: PubMed 28687517Choe AS, Nebel MB, Barber AD, Cohen JR, Xu Y, Pekar JJ, Caffo B, Lindquist MA. Comparing test-retest reliability of dynamic functional connectivity methods. Neuroimage. 2017 Sep;158:155-175. doi: 10.1016/j.neuroimage.2017.07.005. Epub 2017 Jul 5.
- Background: PubMed 26517540Choe AS, Jones CK, Joel SE, Muschelli J, Belegu V, Caffo BS, Lindquist MA, van Zijl PC, Pekar JJ. Reproducibility and Temporal Structure in Weekly Resting-State fMRI over a Period of 3.5 Years. PLoS One. 2015 Oct 30;10(10):e0140134. doi: 10.1371/journal.pone.0140134. eCollection 2015.
- Background: PubMed 23805087Choe AS, Belegu V, Yoshida S, Joel S, Sadowsky CL, Smith SA, van Zijl PC, Pekar JJ, McDonald JW. Extensive neurological recovery from a complete spinal cord injury: a case report and hypothesis on the role of cortical plasticity. Front Hum Neurosci. 2013 Jun 25;7:290. doi: 10.3389/fnhum.2013.00290. eCollection 2013.
- Individual participant dataSharing planned: Yes. All research material will be kept confidential and any means of subject identification (name and history number) will be removed from all material for analysis or presentation. No identifying information will be made publicly available. In some cases, the study protocol, statistical analysis plan, individual scans, and all Individual Participant Data (IPD) that underlie results in a publication will be included in published papers or meeting papers or posters, but the identity of the subject in question will not be revealed.
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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. This study is not recruiting at the moment.
Ann S Choe, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electric Stimulation cycling and Passive cycling in people with Spinal Cord Injuries, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. 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 8 inclusion and 8 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 10 Mar 2025. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 10 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) Score (time frame: Baseline). The study lists 9 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 NCT03854214, which also lists 4 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 10 Mar 2025.