Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3NS120191-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Pittsburgh Medical Center | OTHER |
| Carnegie Mellon University | OTHER |
| Synchron Medical, Inc. | INDUSTRY |
| National Institute of Neurological Disorders and Stroke (NINDS) |
Not provided
Not provided
Not provided
Not provided
The investigators will use fMRI to map movement activity in motor and somatosensory cortex using enriched imagery in people with chronic tetraplegia. The investigators expect that somatotopic organization of movement activity will be preserved in people with upper limb impairments, which can be quantified using the strength, area, and location of sensorimotor activity. Accurate mapping of the motor and somatosensory cortices using covert stimuli will help guide brain-computer interface (BCI) electrode design and placement. Moreover, these advanced mapping procedures will provide new insights into the functional interactions between sensory and motor areas of the brain after injury or disease.
BACKGROUND: Advanced understanding of brain structure and function has improved the diagnosis and treatment of neurological disorders such as epilepsy, stroke, and spinal cord injury (SCI). Over half a century ago, the pioneering studies of Penfield used electrical stimulation of motor and sensory areas of cerebral cortex and revealed a distinct somatotopic organization of the brain. Today, this and additional knowledge of neuronal coding functions are being used to develop revolutionary devices that interface directly with motor and sensory neurons in the brain to establish functional connections with prosthetic and assistive devices. These so-called brain-computer interfaces (BCIs) require electrodes to be placed precisely in brain areas responsible for volitional control and sensation of limb movements, particularly the arm and hand regions. Mapping those brain regions is possible using functional magnetic resonance imaging (fMRI). However, such mapping studies are difficult to perform in persons with motor and sensory impairments. People with ALS and SCI have disrupted efferent and afferent pathways between the cortex and the limbs making it necessary to rely on covert techniques, such as kinesthetic motor imagery, to map sensorimotor brain activity in order to guide BCI electrode placement or to study cortical plasticity resulting from injury or intervention. Challenges associated with brain mapping after injury likely contribute to the widely varying reports regarding the extent and prevalence of functional reorganization occurring in the brain following SCI. fMRI is a non-invasive tool that allows for measurement of motor and sensory-related brain activity with minimal risk to study participants.
SIGNIFICANCE: Restoration of upper limb function is a top priority for individuals with tetraplegia. It is estimated that 236,000-327,000 people in the United States have a spinal cord injury. Approximately 17% of people with SCI have high tetraplegia (injury at cervical levels C1-C4) although this percentage has been increasing in recent years. People with high tetraplegia are the most likely group to benefit from BCI-controlled neuroprosthetics, although the covert mapping strategies developed in this proposal could be used to study sensorimotor activation and plasticity in anyone with motor or sensory impairment including amputation. Sophisticated, motorized prostheses are being developed that enable natural upper limb movement and have advanced sensing capabilities. People with tetraplegia would like to restore function to their own limbs using FES, but this technology needs further advancement and does not replace sensation, which may still require a BCI. While FES research and development continues, people with tetraplegia could take advantage of motorized prostheses by mounting them to their wheelchair. Motorized prostheses can provide function comparable to that of an intact limb, but a high degree-of-freedom control interface is needed and BCI is one possible solution.
Functional neuroimaging can be used to guide BCI electrode placement in order to tap into existing sensorimotor circuits. Imagery-based brain mapping also enables the study of cortical plasticity which could be useful for understanding maladaptive cortical changes that occur after injury or beneficial changes resulting from rehabilitation interventions. Just as pre-surgical brain mapping may help identify individuals who are best suited for a BCI, covert brain mapping in someone with motor and sensory impairments may inform the type of rehabilitation paradigm that is most likely to have a benefit. The potential benefit of being able to study cortical plasticity in the absence of movement or sensation is wide-reaching as it could be applied to patients with SCI, amputation, stroke, neurodegenerative diseases like amyotrophic lateral sclerosis, or other sensorimotor impairment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with spinal cord injury (SCI) | Experimental | Individuals will be asked to imagine movements or sensations while fMRI is used to measure brain activity. |
|
| Individuals with amotrophic lateral sclerosis (ALS) | Experimental | Individuals will be asked to imagine movements or sensations while fMRI is used to measure brain activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motor or sensory imagery with fMRI | Other | Brain activity will be measured using fMRI while participants imagine different movements or sensations in order to assess the organization of sensorimotor cortical activity after injury |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Activity Volume: Right D1 Attempt Movement Activity at S1 - SCI | Volume of peak activity strength in sensorimotor cortex for attempted movement of right thumb (D1). | Single visit |
| Peak Activity Volume: Right D2 Attempt Movement Activity at S1 - SCI | Volume of primary activation within sensorimotor cortex for attempted movement of the right index finger (D2) | Single visit |
| Peak Activity Volume: Right D3 Attempt Movement Activity at S1 - SCI | Volume of primary activation within sensorimotor cortex for attempted movement of the right middle finger (D3) | Single visit |
| Peak Activity Volume: Right D4 Attempt Movement Activity at S1 - SCI | Volume of primary activation within sensorimotor cortex for attempted movement of the right ring finger (D4) | Single visit |
| Peak Activity Volume: Right Hand Grasp Overt/Attempt Movement Activity at S1 - SCI | Volume of peak activity cluster for Right hand grasp overt/attempt movement activity at S1 | Single visit |
| Peak Activity Volume: Left Ankle Overt/Attempt Movement Activity at M1 - ALS | Volume of peak activity cluster in M1 during overt/attempted movement of left ankle | Single visit |
| Peak Activity Volume: Right Toe Overt/Attempt Movement Activity at M1 - ALS |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer L Collinger, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
We may share coded imaging data with other researchers.
Deidentified data will be shared upon request to the PI and completion of a data sharing agreement.
People can submit a request to download the data. Requests will be approved after completion of a brief data use agreement. The study PI will review requests to ensure that they are intended for academic purposes.
All individuals were safety screened and underwent functional magnetic resonance imaging. No individuals were excluded.
5 individuals with spinal cord injury: recruited from University of Pittsburgh Physical Medicine & Rehabilitation research registry.
3 individuals with amyotrophic lateral sclerosis: recruited from University of Pittsburgh/UPMC neurologist, David Lacomis, MD.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | S1/ SCI Participants: fMRI w/ Motor or Sensory Imagery | Individuals will be asked to attempt finger and hand movements while fMRI is used to measure brain activity. Motor or sensory imagery: Brain activity will be measured using fMRI while participants imagine different movements or sensations in order to assess the organization of sensorimotor cortical activity after injury. |
| FG001 | M1/ ALS: fMRI w/ Motor or Sensory Imagery | Individuals will be asked to attempt ankle, knee, toe, and hand movements while fMRI is used to measure brain activity. Motor or sensory imagery: Brain activity will be measured using fMRI while participants imagine different movements or sensations in order to assess the organization of sensorimotor cortical activity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Individuals were pre-screened over the phone using an IRB-approved phone screening script. Individuals answered yes or no to certain eligibility criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Spinal Cord Injury | Individuals will be asked to imagine movements or sensations while fMRI is used to measure brain activity. Sensory imagery: Brain activity will be measured using fMRI while participants imagine different movements or sensations in order to assess the organization of sensorimotor cortical activity after injury |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak Activity Volume: Right D1 Attempt Movement Activity at S1 - SCI | Volume of peak activity strength in sensorimotor cortex for attempted movement of right thumb (D1). | Individuals with hand impairment due to cervical spinal cord injury | Posted | Mean | Full Range | mm^3 | Single visit |
|
|
1 visit (approximately 4 hours)
Adverse events are observed by the participant or the study team. These may include: falling during transfer to MRI surface, claustrophobia, burn from metal implant.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Spinal Cord Injury | Individuals will be asked to imagine movements or sensations while fMRI is used to measure brain activity. Motor or sensory imagery: Brain activity will be measured using fMRI while participants imagine different movements or sensations in order to assess the organization of sensorimotor cortical activity after injury. |
Not provided
Not provided
Area of peak activity was not calculated and instead the volume and location coordinates were provided for peak activity of various movements associated with hand movements. Also, the volume or locations of activity that had statistically significant activity were included.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Debbie Harrington, CCRP | University of Pittsburgh | 412-383-1355 | debbie.harrington@pitt.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2023 | Jun 27, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2022 | May 28, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| NIH |
Participants will be asked to imagine movements or sensensations while brain activity is measured with fMRI
Not provided
Not provided
Not provided
Not provided
Volume of peak activity cluster in M1 during attempted movement of right toe by individuals with ALS
| Single visit |
| Peak Activity Volume: Right Hand Grasp Overt/Attempt Movement Activity at M1 - ALS | Volume of peak activity cluster in M1 during attempted right hand grasp movement by individuals with ALS | Single visit |
| Location of Peak Activity (X-coordinate) for Right D1 Attempt Movement - SCI | This is the X-axis (right to left of head) coordinate for location of peak activity for attempted movement of right D1. | Single visit |
| Location of Peak Activity (Y-coordinate) for Right D1 Attempt Movement - SCI | This is the Y-axis (vertical) coordinate for location of peak activity for attempted movement of right D1. | Single visit |
| Location of Peak Activity (Z-coordinate) for Right D1 Attempt Movement - SCI | This is the Z-axis (front to back of head) coordinate for location of peak activity for attempted movement of right D1. | Single visit |
| Location of Peak Activity (X-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS | This is the X-axis (right to left of head) coordinate for location of peak activity for M1 during overt/attempted movement of left ankle. | Single visit |
| Location of Peak Activity (Y-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS | This is the Y-axis (right to left of head) coordinate for location of peak activity for M1 during overt/attempted movement of left ankle. | Single visit |
| Location of Peak Activity (Z-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS | This is the Z-axis (right to left of head) coordinate for location of peak activity for M1 during overt/attempted movement of left ankle. | Single visit |
| Location of Peak Activity (X-axis): Right Hand Grasp - SCI | Location of peak activity (X-axis coordinate): Right hand grasp overt/attempt movement activity at S1 | Single visit |
| Location of Peak Activity (Y-axis): Right Hand Grasp - SCI | Location of peak activity (Y-axis coordinate): Right hand grasp overt/attempt movement activity at S1 | Single visit |
| Location of Peak Activity (Z-axis): Right Hand Grasp - SCI | Location of peak activity (Z-axis coordinate): Right hand grasp overt/attempt movement activity at S1 | Single visit |
| BG001 |
| Participants With Amyotrophic Lateral Sclerosis |
Individuals will be asked to imagine movements or sensations while fMRI is used to measure brain activity. Motor imagery: Brain activity will be measured using fMRI while participants imagine different movements or sensations in order to assess the organization of sensorimotor cortical activity after injury |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants with movement-related brain activation | Number of individuals who showed movement-related brain activity. | Count of Participants | Participants |
|
|
| Primary | Peak Activity Volume: Right D2 Attempt Movement Activity at S1 - SCI | Volume of primary activation within sensorimotor cortex for attempted movement of the right index finger (D2) | Individuals with hand impairment due to cervical spinal cord injury | Posted | Mean | Full Range | mm^3 (cubic millimeters) | Single visit |
|
|
|
| Primary | Peak Activity Volume: Right D3 Attempt Movement Activity at S1 - SCI | Volume of primary activation within sensorimotor cortex for attempted movement of the right middle finger (D3) | Individuals with hand impairment due to cervical spinal cord injury | Posted | Mean | Full Range | mm^3 (cubic millimeters) | Single visit |
|
|
|
| Primary | Peak Activity Volume: Right D4 Attempt Movement Activity at S1 - SCI | Volume of primary activation within sensorimotor cortex for attempted movement of the right ring finger (D4) | Individuals with hand impairment due to cervical spinal cord injury | Posted | Mean | Full Range | mm^3 (cubic millimeters) | Single visit |
|
|
|
| Primary | Peak Activity Volume: Right Hand Grasp Overt/Attempt Movement Activity at S1 - SCI | Volume of peak activity cluster for Right hand grasp overt/attempt movement activity at S1 | Individuals with hand impairment due to cervical spinal cord injury | Posted | Mean | Full Range | mm^3 (cubic millimeters) | Single visit |
|
|
|
| Primary | Peak Activity Volume: Left Ankle Overt/Attempt Movement Activity at M1 - ALS | Volume of peak activity cluster in M1 during overt/attempted movement of left ankle | Impairment of at least one arm/hand as a result of cervical spinal cord injury | Posted | Mean | Full Range | mm^3 (cubic millimeters) | Single visit |
|
|
|
| Primary | Peak Activity Volume: Right Toe Overt/Attempt Movement Activity at M1 - ALS | Volume of peak activity cluster in M1 during attempted movement of right toe by individuals with ALS | Impairment of at least one arm/hand as a result of cervical spinal cord injury or amyotrophic lateral sclerosis. The ALS diagnosis should be possible, probably, or definite ALS based on El Escorial criteria. | Posted | Mean | Full Range | mm^3 (cubic millimeters) | Single visit |
|
|
|
| Primary | Peak Activity Volume: Right Hand Grasp Overt/Attempt Movement Activity at M1 - ALS | Volume of peak activity cluster in M1 during attempted right hand grasp movement by individuals with ALS | Impairment of at least one arm/hand as a result of cervical spinal cord injury or amyotrophic lateral sclerosis. The ALS diagnosis should be possible, probably, or definite ALS based on El Escorial criteria. | Posted | Mean | Full Range | mm^3 (cubic millimeters) | Single visit |
|
|
|
| Primary | Location of Peak Activity (X-coordinate) for Right D1 Attempt Movement - SCI | This is the X-axis (right to left of head) coordinate for location of peak activity for attempted movement of right D1. | The x-axis coordinate is the left-to-right location of the peak activity. | Posted | Mean | Full Range | mm | Single visit |
|
|
|
| Primary | Location of Peak Activity (Y-coordinate) for Right D1 Attempt Movement - SCI | This is the Y-axis (vertical) coordinate for location of peak activity for attempted movement of right D1. | Posted | Mean | Full Range | mm | Single visit |
|
|
|
| Primary | Location of Peak Activity (Z-coordinate) for Right D1 Attempt Movement - SCI | This is the Z-axis (front to back of head) coordinate for location of peak activity for attempted movement of right D1. | Posted | Mean | Full Range | mm | Single visit |
|
|
|
| Primary | Location of Peak Activity (X-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS | This is the X-axis (right to left of head) coordinate for location of peak activity for M1 during overt/attempted movement of left ankle. | Posted | Mean | Full Range | mm | Single visit |
|
|
|
| Primary | Location of Peak Activity (Y-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS | This is the Y-axis (right to left of head) coordinate for location of peak activity for M1 during overt/attempted movement of left ankle. | Posted | Mean | Full Range | mm | Single visit |
|
|
|
| Primary | Location of Peak Activity (Z-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS | This is the Z-axis (right to left of head) coordinate for location of peak activity for M1 during overt/attempted movement of left ankle. | Posted | Mean | Full Range | mm | Single visit |
|
|
|
| Primary | Location of Peak Activity (X-axis): Right Hand Grasp - SCI | Location of peak activity (X-axis coordinate): Right hand grasp overt/attempt movement activity at S1 | Posted | Mean | Full Range | mm | Single visit |
|
|
|
| Primary | Location of Peak Activity (Y-axis): Right Hand Grasp - SCI | Location of peak activity (Y-axis coordinate): Right hand grasp overt/attempt movement activity at S1 | Posted | Mean | Full Range | mm | Single visit |
|
|
|
| Primary | Location of Peak Activity (Z-axis): Right Hand Grasp - SCI | Location of peak activity (Z-axis coordinate): Right hand grasp overt/attempt movement activity at S1 | Posted | Mean | Full Range | mm | Single visit |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Participants With Amyotrophic Lateral Sclerosis | Individuals will be asked to imagine movements or sensations while fMRI is used to measure brain activity. Motor or sensory imagery: Brain activity will be measured using fMRI while participants imagine different movements or sensations in order to assess the organization of sensorimotor cortical activity after injury. | 0 | 3 | 0 | 3 | 0 | 3 |
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |