Corticospinal Function After Spinal Cord Injury

NCT ID: NCT02451683

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-12

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Electrophysiology Assessment of Time Domain

Assessment of electrophysiology in the time domain to examin temporal organization of corticospinal function

Group Type OTHER

Electrophysiology Assessment of Time Domain

Intervention Type OTHER

Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability.

Training with some stimulation

Intervention Type OTHER

motor task combined with real or sham stimulation

Electrophysiology Assessment of Location

Assessment of electrophysiology to examine spatial organization of corticospinal function

Group Type EXPERIMENTAL

Electrophysiology Assessment of Location

Intervention Type OTHER

Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability

Training with some stimulation

Intervention Type OTHER

motor task combined with real or sham stimulation

Training with some stimulation

Training with non-invasive stimulation and training with sham stimulation

Group Type ACTIVE_COMPARATOR

Training with some stimulation

Intervention Type OTHER

motor task combined with real or sham stimulation

Interventions

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Electrophysiology Assessment of Time Domain

Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability.

Intervention Type OTHER

Electrophysiology Assessment of Location

Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability

Intervention Type OTHER

Training with some stimulation

motor task combined with real or sham stimulation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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


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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role lead

Responsible Party

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Monica Perez

Scientific Chair Arms + Hands AbilityLab

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Monica Perez, PT PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

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Shirley Ryan AbilityLab

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Monica A Perez, PhD, PT

Role: CONTACT

312-238-2886

Facility Contacts

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Monica A Perez, PhD, PT

Role: primary

312-238-2886

PhD

Role: backup

Other Identifiers

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R01NS090622-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00210458

Identifier Type: -

Identifier Source: org_study_id

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