Sensorimotor Imaging for Brain-Computer Interfaces

NCT04723823 | Completed Results

• 2 other identifiers: STUDY190603141UG3NS120191-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Neuroimaging

Keywords

tetraplegia; ALS; amyotropic lateral sclerosis

Outcome Measures

Primary Outcomes (17)

• 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

  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

Study Arms (2)

Individuals with spinal cord injury (SCI)

EXPERIMENTAL

Individuals will be asked to imagine movements or sensations while fMRI is used to measure brain activity.

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.

Other: Motor or sensory imagery with fMRI

Interventions

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

Individuals with amotrophic lateral sclerosis (ALS); Individuals with spinal cord injury (SCI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Pittsburgh Medical Center: collaborator
• Carnegie Mellon University: collaborator
• Synchron Medical, Inc.: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Debbie Harrington, CCRP
• Organization: University of Pittsburgh

debbie.harrington@pitt.edu

412-383-1355

Study Officials

• Jennifer L Collinger, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 26, 2021
• Study Start: August 8, 2019
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: August 30, 2024
• Results First Posted: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Deidentified data will be shared upon request to the PI and completion of a data sharing agreement.
• Access Criteria: 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.

Locations

US (1)