Functional NeuroimagingNCT04723823
Sensorimotor Imaging for Brain-Computer Interfaces
A study testing Motor or sensory imagery with fMRI in people with Functional Neuroimaging, run by University of Pittsburgh at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Neuroimaging
- What is being tested?
- Motor or sensory imagery with fMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2019to 21 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Normal or corrected to normal vision
- 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, probable, or definite ALS based on El Escorial criteria.
- Decreased or absent sensation or impaired hand movement
- Score of <10 on the Short Blessed Test cognitive assessment
Who cannot join
- Pacemaker, baclofen pump, cochlear implant or other electronic implanted device
- Metallic implant that is unsafe for 3T MRI
- Pregnant females
- Individuals who weigh over 300 pounds (because of MRI risks/space)
- Individuals who have difficulty breathing when laying down (orthopnea)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Mapping of Motor and Sensory Brain Activity Using fMRI
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.
Read the detailed description
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.
- Conditions
- Functional Neuroimaging
- Being tested
- Motor or sensory imagery with fMRI
- Keywords
- tetraplegia, ALS, amyotropic lateral sclerosis
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor or sensory imagery with fMRIOther
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
| Study group | Role | What they receive |
|---|---|---|
| Individuals with spinal cord injury (SCI) | Experimental | Individuals will be asked to imagine movements or sensations while fMRI is used to measure brain activity. Receives: Other: Motor or sensory imagery with fMRI |
| Individuals with amotrophic lateral sclerosis (ALS) | Experimental | Individuals will be asked to imagine movements or sensations while fMRI is used to measure brain activity. Receives: Other: Motor or sensory imagery with fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Single visit
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start8 Aug 2019
- Primary completion21 May 2024
- Study completion21 May 2024
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.
- Other trials for Functional NeuroimagingStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Participants will be asked to imagine movements or sensensations while brain activity is measured with fMRI
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Medical Center, Carnegie Mellon University, Synchron Medical, Inc., National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Jennifer Collinger, PhD, University of Pittsburgh
- Investigators
- Jennifer L Collinger, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723823
- Sponsor's protocol ID
- STUDY19060314
- Other IDs
- 1UG3NS120191-01
- Status last verified
- Aug 2024
- First submitted
- 7 Jan 2021
- Last updated
- 30 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We may share coded imaging data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping of Motor and Sensory Brain Activity Using fMRI
- ClinicalTrials.gov ID
- NCT04723823
- Acronym / sponsor ID
- STUDY19060314
- Conditions
- Functional Neuroimaging
- Keywords
- tetraplegia, ALS, amyotropic lateral sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Pittsburgh Medical Center, Carnegie Mellon University, Synchron Medical, Inc., National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Posted 30 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be asked to imagine movements or sensensations while brain activity is measured with fMRI
| Arm | Type | Receives |
|---|---|---|
| Individuals with spinal cord injury (SCI) | Experimental | Other: Motor or sensory imagery with fMRIIndividuals will be asked to imagine movements or sensations while fMRI is used to measure brain activity. |
| Individuals with amotrophic lateral sclerosis (ALS) | Experimental | Other: Motor or sensory imagery with fMRIIndividuals will be asked to imagine movements or sensations while fMRI is used to measure brain activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Normal or corrected to normal vision
- 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, probable, or definite ALS based on El Escorial criteria.
- Decreased or absent sensation or impaired hand movement
- Score of <10 on the Short Blessed Test cognitive assessment
Key exclusion criteria (5 listed)
- Pacemaker, baclofen pump, cochlear implant or other electronic implanted device
- Metallic implant that is unsafe for 3T MRI
- Pregnant females
- Individuals who weigh over 300 pounds (because of MRI risks/space)
- Individuals who have difficulty breathing when laying down (orthopnea)
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 |
|---|---|---|
| Motor or sensory imagery with fMRIBrain 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 | Other | Individuals with amotrophic lateral sclerosis (ALS), Individuals with spinal cord injury (SCI) |
Primary outcome
Peak Activity Volume: Right D1 Attempt Movement Activity at S1 - SCI
Time frame: Single visit
Volume of peak activity strength in sensorimotor cortex for attempted movement of right thumb (D1).
Peak Activity Volume: Right D2 Attempt Movement Activity at S1 - SCI
Time frame: Single visit
Volume of primary activation within sensorimotor cortex for attempted movement of the right index finger (D2)
Peak Activity Volume: Right D3 Attempt Movement Activity at S1 - SCI
Time frame: Single visit
Volume of primary activation within sensorimotor cortex for attempted movement of the right middle finger (D3)
Peak Activity Volume: Right D4 Attempt Movement Activity at S1 - SCI
Time frame: Single visit
Volume of primary activation within sensorimotor cortex for attempted movement of the right ring finger (D4)
Peak Activity Volume: Right Hand Grasp Overt/Attempt Movement Activity at S1 - SCI
Time frame: Single visit
Volume of peak activity cluster for Right hand grasp overt/attempt movement activity at S1
Peak Activity Volume: Left Ankle Overt/Attempt Movement Activity at M1 - ALS
Time frame: Single visit
Volume of peak activity cluster in M1 during overt/attempted movement of left ankle
Peak Activity Volume: Right Toe Overt/Attempt Movement Activity at M1 - ALS
Time frame: Single visit
Volume of peak activity cluster in M1 during attempted movement of right toe by individuals with ALS
Peak Activity Volume: Right Hand Grasp Overt/Attempt Movement Activity at M1 - ALS
Time frame: Single visit
Volume of peak activity cluster in M1 during attempted right hand grasp movement by individuals with ALS
Location of Peak Activity (X-coordinate) for Right D1 Attempt Movement - SCI
Time frame: Single visit
This is the X-axis (right to left of head) coordinate for location of peak activity for attempted movement of right D1.
Location of Peak Activity (Y-coordinate) for Right D1 Attempt Movement - SCI
Time frame: Single visit
This is the Y-axis (vertical) coordinate for location of peak activity for attempted movement of right D1.
Location of Peak Activity (Z-coordinate) for Right D1 Attempt Movement - SCI
Time frame: Single visit
This is the Z-axis (front to back of head) coordinate for location of peak activity for attempted movement of right D1.
Location of Peak Activity (X-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS
Time frame: Single visit
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.
Location of Peak Activity (Y-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS
Time frame: Single visit
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.
Location of Peak Activity (Z-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS
Time frame: Single visit
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.
Location of Peak Activity (X-axis): Right Hand Grasp - SCI
Time frame: Single visit
Location of peak activity (X-axis coordinate): Right hand grasp overt/attempt movement activity at S1
Location of Peak Activity (Y-axis): Right Hand Grasp - SCI
Time frame: Single visit
Location of peak activity (Y-axis coordinate): Right hand grasp overt/attempt movement activity at S1
Location of Peak Activity (Z-axis): Right Hand Grasp - SCI
Time frame: Single visit
Location of peak activity (Z-axis coordinate): Right hand grasp overt/attempt movement activity at S1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We may share coded imaging data with other researchers.
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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.
Jennifer L Collinger, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor or sensory imagery with fMRI in people with Functional Neuroimaging, run by University of Pittsburgh 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 5 inclusion and 5 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 30 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 30 Aug 2024). 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?
Peak Activity Volume: Right D1 Attempt Movement Activity at S1 - SCI (time frame: Single visit). The study lists 17 primary outcomes in all. 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 30 Aug 2024.