StrokeNCT06598150
Mapping Corticoreticulospinal Motor Control in Chronic Hemiparetic Stroke
A study testing Shoulder Abduction in people with Stroke and Hemiparesis, run by Northwestern University at 1 site in United States.
Trial summary
This study uses functional magnetic resonance imaging to map neural activity throughout the central nervous system during a shoulder abduction task to characterize what motor pathways are being used post-stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Shoulder Abduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2023to 31 Aug 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged at least 18y
- Able to perform shoulder abduction task (confirmed during screening and initial examination)
- Safe to undergo MRI
- Able to follow visual instructions using MRI-compatible vision correction goggles
- No brainstem or cerebellar lesions
- No severe concurrent medical problems
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- Cognitive/attentional capacity to focus on a task
- Able to communicate in English or Spanish
- Additional inclusion criteria for stroke participants:
- Have sustained only one unilateral subcortical, ischemic lesion in the territory supplied by the Middle Cerebral Artery (confirmed by clinical or radiological reports) at least one year prior to participation in this project
- Paresis confined to one side, with moderate-to-severe motor impairment of the upper limb (Upper Extremity Fugl-Meyer score between 10 and 45).
Who cannot join
- MRI contraindications
- Severe claustrophobia
- Pregnant women
- Prisoners
- Vulnerable populations
- Diagnosis/history of:
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- multiple sclerosis
- brain tumor
- brain radiation
- traumatic brain injury
- dementia
- Parkinson's disease
- Concurrent enrollment in an intervention study
- Concurrent use of medications known to suppress central nervous system activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Michelle Medina, BS, 872-272-7687, anvil@northwestern.edu
Molly Bright, DPhil
About this study
Official title: Mapping Corticoreticulospinal Motor Control Using Brainstem and Spinal Cord fMRI in Chronic Hemiparetic Stroke
This study uses functional magnetic resonance imaging to map neural activity throughout the central nervous system during a shoulder abduction task to characterize what motor pathways are being used post-stroke.
Read the detailed description
Nearly 85% of stroke survivors experience significant unilateral impairment in upper extremity motor control, typically caused by damage to the corticospinal (CST) and corticoreticular (CRT) tracts (i.e., the corticofugal tracts). Alternative neural pathways, such as the contralesional cortico-reticulospinal tract (CRST), can be recruited to achieve movement of the affected arm and hand, but may have undesirable consequences. For example, the diffuse, bilateral branching of reticulospinal neurons can produce abnormal muscle co-activations (synergies) in the paretic limb, and involuntary mirror movements (associated reactions) between limbs. Together, these effects create stereotypical movement patterns post-stroke, and there is growing interest in novel \"anti-synergy\" interventions to enhance usage of residual CST systems rather than strengthening the CRST. Imaging has the potential to become an invaluable tool for evaluating whether rehabilitative strategies can preferentially access CST versus CRST pathways. However, current functional imaging research has focused on cortical activity, and must theoretically infer what pathway is used. Structural MRI directly assesses changes in white matter pathways, but it is limited to detecting long-term plasticity. To guide new interventions, there is a critical need to directly evaluate what descending motor pathways are active during movement. Thus, the overall objective of this study is to generate a novel fMRI dataset in participants with post-stroke hemiparesis, capturing neural activity during an innovative isometric shoulder abduction task, evaluating differences when abducting the paretic versus non-paretic arm. The investigators will acquire multi-echo fMRI data in individuals with post-stroke hemiparesis and age-matched controls, hypothesizing that increased reliance on the CRST will cause distinct activation patterns during shoulder abduction with the paretic limb, and that this will correlate with individual upper-extremity impairment (Upper-Extremity Fugl-Meyer Assessment). This work is significant because it will provide direct evidence of descending contralesional motor pathway involvement in post-stroke hemiparesis, and demonstrate the utility of neuroimaging for optimizing movements to preferentially engage specific systems and promote desired neural plasticity following injury.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Shoulder Abduction
- Keywords
- functional magnetic resonance imaging
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder AbductionOther
Individuals will be visually cued to perform short, unilateral, isometric shoulder abduction tasks. A visual display will provide real-time feedback of the shoulder abduction torque, to help the participant target a predetermined torque level.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder Abduction | Experimental | Not described Receives: Other: Shoulder Abduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD activation
BOLD fMRI data will be analyzed to map neural activation associated with the shoulder abduction task.
Measured: 3 days to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 May 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Molly Bright, Northwestern University
- Investigators
- Molly G Bright, DPhil, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598150
- Sponsor's protocol ID
- STU00214855
- Other IDs
- 1R03HD113915-01
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: MR imaging data and the associated physiologic data collected during MRI scanning will be shared in an anonymized format. These data will be made available to public through the Open Science Framework (osf.io) or similar public repository. Code will be made available through the PI's laboratory Github account. A link to these resources will be included with publications resulting from this study to facilitate access.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Corticoreticulospinal Motor Control Using Brainstem and Spinal Cord fMRI in Chronic Hemiparetic Stroke
- ClinicalTrials.gov ID
- NCT06598150
- Acronym / sponsor ID
- STU00214855
- Conditions
- Stroke, Hemiparesis
- Keywords
- functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 20 May 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
This study uses functional magnetic resonance imaging to map neural activity throughout the central nervous system during a shoulder abduction task to characterize what motor pathways are being used post-stroke.
Detailed description
Nearly 85% of stroke survivors experience significant unilateral impairment in upper extremity motor control, typically caused by damage to the corticospinal (CST) and corticoreticular (CRT) tracts (i.e., the corticofugal tracts). Alternative neural pathways, such as the contralesional cortico-reticulospinal tract (CRST), can be recruited to achieve movement of the affected arm and hand, but may have undesirable consequences. For example, the diffuse, bilateral branching of reticulospinal neurons can produce abnormal muscle co-activations (synergies) in the paretic limb, and involuntary mirror movements (associated reactions) between limbs. Together, these effects create stereotypical movement patterns post-stroke, and there is growing interest in novel \"anti-synergy\" interventions to enhance usage of residual CST systems rather than strengthening the CRST. Imaging has the potential to become an invaluable tool for evaluating whether rehabilitative strategies can preferentially access CST versus CRST pathways. However, current functional imaging research has focused on cortical activity, and must theoretically infer what pathway is used. Structural MRI directly assesses changes in white matter pathways, but it is limited to detecting long-term plasticity. To guide new interventions, there is a critical need to directly evaluate what descending motor pathways are active during movement. Thus, the overall objective of this study is to generate a novel fMRI dataset in participants with post-stroke hemiparesis, capturing neural activity during an innovative isometric shoulder abduction task, evaluating differences when abducting the paretic versus non-paretic arm. The investigators will acquire multi-echo fMRI data in individuals with post-stroke hemiparesis and age-matched controls, hypothesizing that increased reliance on the CRST will cause distinct activation patterns during shoulder abduction with the paretic limb, and that this will correlate with individual upper-extremity impairment (Upper-Extremity Fugl-Meyer Assessment). This work is significant because it will provide direct evidence of descending contralesional motor pathway involvement in post-stroke hemiparesis, and demonstrate the utility of neuroimaging for optimizing movements to preferentially engage specific systems and promote desired neural plasticity following injury.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder Abduction | Experimental | Other: Shoulder Abduction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults aged at least 18y
- Able to perform shoulder abduction task (confirmed during screening and initial examination)
- Safe to undergo MRI
- Able to follow visual instructions using MRI-compatible vision correction goggles
- No brainstem or cerebellar lesions
Key exclusion criteria (14 listed)
- MRI contraindications
- Severe claustrophobia
- Pregnant women
- Prisoners
- Vulnerable populations
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 |
|---|---|---|
| Shoulder AbductionIndividuals will be visually cued to perform short, unilateral, isometric shoulder abduction tasks. A visual display will provide real-time feedback of the shoulder abduction torque, to help the participant target a predetermined torque level. | Other | Shoulder Abduction |
Primary outcome
BOLD activation
Time frame: 3 days to 3 months
BOLD fMRI data will be analyzed to map neural activation associated with the shoulder abduction task.
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 1 Oct 2025.
- Individual participant dataSharing planned: Yes. MR imaging data and the associated physiologic data collected during MRI scanning will be shared in an anonymized format. These data will be made available to public through the Open Science Framework (osf.io) or similar public repository. Code will be made available through the PI's laboratory Github account. A link to these resources will be included with publications resulting from this study to facilitate access.
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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.
Molly G Bright, DPhil principal investigator
Northwestern 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 Shoulder Abduction in people with Stroke and Hemiparesis, run by Northwestern University 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 11 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 1 Oct 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. 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 Michelle Medina, BS (872-272-7687, anvil@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD activation (time frame: 3 days to 3 months). 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 1 Oct 2025.