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临床试验/NCT04723823
NCT04723823招募中不适用

Mapping of Motor and Sensory Brain Activity Using fMRI

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
Location of Peak Activity (Y-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Location of Peak Activity (Y-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS

时间窗: 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.

Peak Activity Volume: Right D1 Attempt Movement Activity at S1 - SCI

时间窗: 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

时间窗: 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

时间窗: Single visit

Volume of primary activation within sensorimotor cortex for attempted movement of the right middle finger (D3)

Peak Activity Volume: Right Hand Grasp Overt/Attempt Movement Activity at S1 - SCI

时间窗: 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

时间窗: Single visit

Volume of peak activity cluster in M1 during overt/attempted movement of left ankle

Location of Peak Activity (Z-coordinate) for Right D1 Attempt Movement - SCI

时间窗: 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

时间窗: 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.

Peak Activity Volume: Right D4 Attempt Movement Activity at S1 - SCI

时间窗: 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 M1 - ALS

时间窗: Single visit

Volume of peak activity cluster in M1 during attempted right hand grasp movement by individuals with ALS

Peak Activity Volume: Right Toe Overt/Attempt Movement Activity at M1 - ALS

时间窗: Single visit

Volume of peak activity cluster in M1 during attempted movement of right toe by individuals with ALS

Location of Peak Activity (Y-coordinate) for Right D1 Attempt Movement - SCI

时间窗: Single visit

This is the Y-axis (vertical) coordinate for location of peak activity for attempted movement of right D1.

Location of Peak Activity (X-coordinate) for Right D1 Attempt Movement - SCI

时间窗: 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 (Z-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Single visit

Location of peak activity (Z-axis coordinate): Right hand grasp overt/attempt movement activity at S1

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Collinger, PhD

Associate Professor

University of Pittsburgh

研究点 (2)

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