Mapping Corticoreticulospinal Motor Control in Chronic Hemiparetic Stroke

September 26, 2025 updated by: Molly Bright, Northwestern University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Molly Bright, DPhil
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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
  • 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).

Exclusion Criteria:

  • MRI contraindications
  • Severe claustrophobia
  • Pregnant women
  • Prisoners
  • Vulnerable populations
  • Diagnosis/history of:
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Shoulder Abduction
Other: Shoulder Abduction
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 days to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Molly G Bright, DPhil, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU00214855
  • 1R03HD113915-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

At time of publication (or at project completion, whichever occurs first).

IPD Sharing Access Criteria

Data will be anonymized and made publicly available, and at that time no approval is needed and therefore there are no access criteria.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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