N/A
N=8
Sensorimotor Imaging for Brain-Computer Interfaces
Functional Neuroimaging
Bottom Line
View on ClinicalTrials.gov: NCT04723823 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Peak Activity Volume: Right D1 Attempt Movement Activity at S1 - SCI — 893.6 mm^3
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Motor or sensory imagery with fMRI (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Activity Volume: Right D1 Attempt Movement Activity at S1 - SCI |
893.6 | — |
| PRIMARY Peak Activity Volume: Right D2 Attempt Movement Activity at S1 - SCI |
549 | — |
| PRIMARY Peak Activity Volume: Right D3 Attempt Movement Activity at S1 - SCI |
391.75 | — |
| PRIMARY Peak Activity Volume: Right D4 Attempt Movement Activity at S1 - SCI |
221.5 | — |
| PRIMARY Peak Activity Volume: Right Hand Grasp Overt/Attempt Movement Activity at S1 - SCI |
2588.8 | — |
| PRIMARY Peak Activity Volume: Left Ankle Overt/Attempt Movement Activity at M1 - ALS |
437 | — |
| PRIMARY Peak Activity Volume: Right Toe Overt/Attempt Movement Activity at M1 - ALS |
251.5 | — |
| PRIMARY Peak Activity Volume: Right Hand Grasp Overt/Attempt Movement Activity at M1 - ALS |
238.5 | — |
| PRIMARY Location of Peak Activity (X-coordinate) for Right D1 Attempt Movement - SCI |
176.4 | — |
| PRIMARY Location of Peak Activity (Y-coordinate) for Right D1 Attempt Movement - SCI |
67 | — |
| PRIMARY Location of Peak Activity (Z-coordinate) for Right D1 Attempt Movement - SCI |
103.2 | — |
| PRIMARY Location of Peak Activity (X-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS |
123.33 | — |
| PRIMARY Location of Peak Activity (Y-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS |
63.67 | — |
| PRIMARY Location of Peak Activity (Z-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS |
87.67 | — |
| PRIMARY Location of Peak Activity (X-axis): Right Hand Grasp - SCI |
163.6 | — |
| PRIMARY Location of Peak Activity (Y-axis): Right Hand Grasp - SCI |
59.4 | — |
| PRIMARY Location of Peak Activity (Z-axis): Right Hand Grasp - SCI |
93 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT04723823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.