Corticospinal Function After Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Corticospinal Function After Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02451683
• Other study ID #: STU00210458
• Secondary ID: R01NS090622-01
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: December 30, 2026

Study information

• Verified date: March 2024
• Source: Shirley Ryan AbilityLab
• Contact: Monica A Perez, PhD, PT
• Phone: 312-238-2886
• Email: mperez04[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigator's overall goal is to develop new strategies to test optimization of Spike-timing-dependent plasticity (STDP) doses to maximize strategy to restore upper and lower-limb motor function in individuals with spinal cord injury (SCI). The investigator proposes to use modern electrophysiological methods to enhance the efficacy of residual corticospinal connections. Defining the neural basis by which corticospinal volleys generate muscle responses will provide crucial information required to maximize residual motor output. The investigator's specific goals are to: 1) determine the temporal and spatial organization of corticospinal volleys and motor cortical representations of upper-limb muscles after incomplete cervical SCI and 2) develop methodologies to promote recovery of function. The investigator's focus on reach and grasp movements because of their importance in daily life activities.

Description:

This study will determine the temporal organization of corticospinal volleys during reach and grasp movements. Multiple descending volleys in the corticospinal tract generate multiple peaks in muscle responses (indirect (I)-waves). I-waves are a mechanism by which corticospinal neurons are transynaptically activated at periodic intervals of ~1.5 ms. This periodic activation contributes to the recruitment of spinal motoneurons and generation of movement. we will use paired-TMS to examine I-waves in surface EMG recordings from upper-limb muscles during reach and grasp movements. We will also identify motor cortical maps of upper-limb muscles involved in reach and grasp movements. We will use TMS guided by a frameless neuronavigation system to define the size and location of motor cortical maps of upper-limb muscles during reach and grasp movements. We will be able to determine overlaps and functional interactions between distal and proximal arm motor cortical representations. Our preliminary data shows that finger and biceps cortical maps largely overlap during reach and grasp movements in controls but considerable less in patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria for individuals with SCI:

1. Male and females between 18-85 years,

2. Chronic SCI (= 6 months post injury),

3. Cervical injury at C8 or above,

4. Intact or impaired but not absent innervations in dermatomes C6, C7, and C8 using the American Spinal Injury Association sensory scores, and

5. Ability to reach and grasp a small object located at least 8 cm forward, above, and laterally without leaning forward with the trunk

Inclusion criteria for healthy controls:

1. Male and females between 18-85 years,

2. Right handed,

3. Ability to reach and grasp a small object located at least 8 cm forward, above, and laterally without leaning forward with the trunk

Exclusion Criteria:

• Exclusion criteria for individuals with SCI and Healthy Controls:

1. Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease

2. Any debilitating disease prior to the SCI that caused exercise intolerance

3. Premorbid, ongoing major depression or psychosis, altered cognitive status

4. History of head injury or stroke

5. Pacemaker

6. Metal plate in skull

7. History of seizures

8. Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants

9. Pregnant females

10. Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida or herniated cervical disk.

11. History of brain tumor and or brain infection

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Other:
• Electrophysiology Assessment of Time Domain
Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability.
• Electrophysiology Assessment of Location
Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability
• Training with some stimulation
motor task combined with real or sham stimulation

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper-limb motor function	measured by functional tests of hand/arm motor function	5 months
Secondary	Cortical Neurophysiological Outcome	measured by the maps area and overlap in millimeters	5 months
Secondary	Change in Sensorimotor Function	measured by upper-limb movements scale from 1(dependent) to 7 (independent).	5 months