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Sensorimotor Imaging for Brain-Computer Interfaces

Mapping of Motor and Sensory Brain Activity Using fMRI

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04723823
Enrollment
8
Registered
2021-01-26
Start date
2019-08-08
Completion date
2024-05-21
Last updated
2024-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Neuroimaging

Keywords

tetraplegia, ALS, amyotropic lateral sclerosis

Brief 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 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.

Interventions

OTHERMotor or sensory imagery with fMRI

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

Sponsors

University of Pittsburgh Medical Center
CollaboratorOTHER
Carnegie Mellon University
CollaboratorOTHER
Synchron Medical, Inc.
CollaboratorINDUSTRY
National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Participants will be asked to imagine movements or sensensations while brain activity is measured with fMRI

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age 18 or older 2. Normal or corrected to normal vision 3. 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. 4. Decreased or absent sensation or impaired hand movement 5. Score of \<10 on the Short Blessed Test cognitive assessment

Exclusion criteria

1. Pacemaker, baclofen pump, cochlear implant or other electronic implanted device 2. Metallic implant that is unsafe for 3T MRI 3. Pregnant females 4. Individuals who weigh over 300 pounds (because of MRI risks/space) 5. Individuals who have difficulty breathing when laying down (orthopnea)

Design outcomes

Primary

MeasureTime frameDescription
Peak Activity Volume: Right D1 Attempt Movement Activity at S1 - SCISingle visitVolume of peak activity strength in sensorimotor cortex for attempted movement of right thumb (D1).
Peak Activity Volume: Right D2 Attempt Movement Activity at S1 - SCISingle visitVolume 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 - SCISingle visitVolume 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 - SCISingle visitVolume 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 - SCISingle visitVolume 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 - ALSSingle visitVolume of peak activity cluster in M1 during overt/attempted movement of left ankle
Peak Activity Volume: Right Toe Overt/Attempt Movement Activity at M1 - ALSSingle visitVolume 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 - ALSSingle visitVolume 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 - SCISingle visitThis 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 - SCISingle visitThis 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 - SCISingle visitThis 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 - ALSSingle visitThis 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 - ALSSingle visitThis 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 - ALSSingle visitThis 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 - SCISingle visitLocation of peak activity (X-axis coordinate): Right hand grasp overt/attempt movement activity at S1
Location of Peak Activity (Y-axis): Right Hand Grasp - SCISingle visitLocation of peak activity (Y-axis coordinate): Right hand grasp overt/attempt movement activity at S1
Location of Peak Activity (Z-axis): Right Hand Grasp - SCISingle visitLocation of peak activity (Z-axis coordinate): Right hand grasp overt/attempt movement activity at S1

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

All individuals were safety screened and underwent functional magnetic resonance imaging. No individuals were excluded.

Participants by arm

ArmCount
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
5
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
3
Total8

Baseline characteristics

CharacteristicParticipants With Spinal Cord InjuryTotalParticipants With Amyotrophic Lateral Sclerosis
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants2 Participants2 Participants
Age, Categorical
Between 18 and 65 years
5 Participants6 Participants1 Participants
Age, Continuous68.33 years41.88 years26 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants8 Participants3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Participants with movement-related brain activation5 Participants8 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
5 Participants8 Participants3 Participants
Region of Enrollment
United States
5 participants8 participants3 participants
Sex: Female, Male
Female
0 Participants1 Participants1 Participants
Sex: Female, Male
Male
5 Participants7 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 50 / 3
other
Total, other adverse events
0 / 50 / 3
serious
Total, serious adverse events
0 / 50 / 3

Outcome results

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

Time frame: Single visit

ArmMeasureValue (MEAN)
Individuals With SCILocation of Peak Activity (X-axis): Right Hand Grasp - SCI163.6 mm
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.

Time frame: Single visit

ArmMeasureValue (MEAN)
Individuals With SCILocation of Peak Activity (X-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS123.33 mm
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.

Time frame: Single visit

Population: The x-axis coordinate is the left-to-right location of the peak activity.

ArmMeasureValue (MEAN)
Individuals With SCILocation of Peak Activity (X-coordinate) for Right D1 Attempt Movement - SCI176.4 mm
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

Time frame: Single visit

ArmMeasureValue (MEAN)
Individuals With SCILocation of Peak Activity (Y-axis): Right Hand Grasp - SCI59.4 mm
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.

Time frame: Single visit

ArmMeasureValue (MEAN)
Individuals With SCILocation of Peak Activity (Y-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS63.67 mm
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.

Time frame: Single visit

ArmMeasureValue (MEAN)
Individuals With SCILocation of Peak Activity (Y-coordinate) for Right D1 Attempt Movement - SCI67 mm
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

Time frame: Single visit

ArmMeasureValue (MEAN)
Individuals With SCILocation of Peak Activity (Z-axis): Right Hand Grasp - SCI93 mm
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.

Time frame: Single visit

ArmMeasureValue (MEAN)
Individuals With SCILocation of Peak Activity (Z-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS87.67 mm
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.

Time frame: Single visit

ArmMeasureValue (MEAN)
Individuals With SCILocation of Peak Activity (Z-coordinate) for Right D1 Attempt Movement - SCI103.2 mm
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

Time frame: Single visit

Population: Impairment of at least one arm/hand as a result of cervical spinal cord injury

ArmMeasureValue (MEAN)
Individuals With SCIPeak Activity Volume: Left Ankle Overt/Attempt Movement Activity at M1 - ALS437 mm^3 (cubic millimeters)
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).

Time frame: Single visit

Population: Individuals with hand impairment due to cervical spinal cord injury

ArmMeasureValue (MEAN)
Individuals With SCIPeak Activity Volume: Right D1 Attempt Movement Activity at S1 - SCI893.6 mm^3
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)

Time frame: Single visit

Population: Individuals with hand impairment due to cervical spinal cord injury

ArmMeasureValue (MEAN)
Individuals With SCIPeak Activity Volume: Right D2 Attempt Movement Activity at S1 - SCI549 mm^3 (cubic millimeters)
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)

Time frame: Single visit

Population: Individuals with hand impairment due to cervical spinal cord injury

ArmMeasureValue (MEAN)
Individuals With SCIPeak Activity Volume: Right D3 Attempt Movement Activity at S1 - SCI391.75 mm^3 (cubic millimeters)
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)

Time frame: Single visit

Population: Individuals with hand impairment due to cervical spinal cord injury

ArmMeasureValue (MEAN)
Individuals With SCIPeak Activity Volume: Right D4 Attempt Movement Activity at S1 - SCI221.5 mm^3 (cubic millimeters)
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

Time frame: Single visit

Population: 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.

ArmMeasureValue (MEAN)
Individuals With SCIPeak Activity Volume: Right Hand Grasp Overt/Attempt Movement Activity at M1 - ALS238.5 mm^3 (cubic millimeters)
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

Time frame: Single visit

Population: Individuals with hand impairment due to cervical spinal cord injury

ArmMeasureValue (MEAN)
Individuals With SCIPeak Activity Volume: Right Hand Grasp Overt/Attempt Movement Activity at S1 - SCI2588.8 mm^3 (cubic millimeters)
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

Time frame: Single visit

Population: 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.

ArmMeasureValue (MEAN)
Individuals With SCIPeak Activity Volume: Right Toe Overt/Attempt Movement Activity at M1 - ALS251.5 mm^3 (cubic millimeters)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026