Neuroplasticity After Spinal Cord Injury

• ClinicalTrials.gov Identifier: NCT02446210
• Recruitment Status: Unknown
• First Posted: May 18, 2015
• Last Update Posted: May 25, 2021
• Sponsor: Shirley Ryan AbilityLab
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Information provided by (Responsible Party): Monica Perez, Shirley Ryan AbilityLab

Study Description

Brief Summary:

The long-term goal is to acquire scientific knowledge that can be used to develop mechanistic-driven intervention strategies aiming at restoring upper and lower-limb motor function in individuals with cervical or thoracic spinal cord injury (SCI). The proposed project will examine cortical, corticospinal, and spinal contribution to bilateral hand and arm muscle activity during bilateral movements and spinal contributions to lower limb muscle activity. By comparing changes in different sites within the Central Nervous System (CNS), the investigators may also identify key mechanisms that might be differentially affected by the injury, plasticity, and training.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injury	Device: Magstim 200; Device: Digitimer electrical stimulator	Not Applicable

Detailed Description:

If the participant qualifies to take part in this research study, they will be asked to participate in 15-190 study visits,to complete the experimental procedures. These procedures have been broken up into "Phases" and will be completed in any order. Phase I and Phase IIa includes 2-30 total visits - approximately 2-3 hours each to measure arm and finger strength and ability to move. Phase IIb includes 2-30 total visits - approximately 2-3 hours each, to measure leg strength and ability to move. Phase IIIa includes up to 40 total visits - approximately 2 hours each, the investigator will again evaluate the participant's ability to use both arms. The participant will be asked to complete a series of tasks such as stacking checkers, turning over cards, squeeze a device to determine how strong their grip is, and see how well they are able to feel sensations on the surface of their skin. The investigators will complete these assessments at pre-determined times during the study participation. Phase IIIb includes up to 40 total visits - approximately 2 hours each, the investigator will again evaluate the participant's ability to use both legs. Assessments of the participant's legs will include walking around the lab space, how well they can bend their ankles and hips, and how well they are able to feel sensations on the surface of the participant's skin.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 514 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Targeted Neuroplasticity After Spinal Cord Injury
• Actual Study Start Date: January 28, 2021
• Estimated Primary Completion Date: January 27, 2022
• Estimated Study Completion Date: January 27, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Healthy Controls Group; Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation	Device: Magstim 200; Transcranial Magnetic Stimulation; Device: Digitimer electrical stimulator; Transcranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation; Other Name: Electrical stimulation
Active Comparator: Spinal Cord Injury Group; Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation	Device: Magstim 200; Transcranial Magnetic Stimulation; Device: Digitimer electrical stimulator; Transcranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation; Other Name: Electrical stimulation

Outcome Measures

Primary Outcome Measures :

1. Number of participants with reduced motor cortical excitability [ Time Frame: 5 months ]
   Measured by Electroencephalogram/Electromyography and Electromyography/Electromyography coherence

Secondary Outcome Measures :

1. Number of participants with enhance voluntary motor output in upper limbs [ Time Frame: 5 months ]
   Measured by spike-timing-dependent plasticity
2. Number of participants with enhance voluntary motor output in lower limbs [ Time Frame: 5 months ]
   Measured by spike-timing-dependent plasticity

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Inclusion criteria for individuals with SCI:

  • Male and females between ages 18-85 years
  • SCI (≥1 month after injury)
  • Cervical, thoracic or lumbar injury above L2 (tetraplegia)Intact (level 2) or impaired (level 1) but not absent (level 0) lower motor neuron innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the American Spinal Injury Association (ASIA) sensory scores (12)
  • The ability to produce a visible precision grip force with both hands
  • Individuals who have the ability to pick up a small object (large paperclip) from a table independently
  • Ability to perform 30° or more of elbow flexion and extension.
  • The ability to perform a visible contraction with dorsiflexor and hip flexor muscles
  • The ability to ambulate a few steps with or without an assistive device

Inclusion criteria for healthy controls:

• Male and females between ages 18-85 years
• Right handed
• Able to complete precision grips with both hands
• Able to complete full elbow flexion-extension with both arms.
• Able to walk and complete lower-limb tests with both legs.

Exclusion Criteria:

• Exclusion criteria for individuals with SCI and Healthy Controls:

  • Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
  • Any debilitating disease prior to the SCI that caused exercise intolerance
  • Premorbid, ongoing major depression or psychosis, altered cognitive status
  • History of head injury or stroke
  • Pacemaker
  • Metal plate in skull
  • History of seizures
  • Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
  • Pregnant females
  • 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.

Contacts and Locations

Contacts

Contact: Monica A Perez, PhD, PT; 312-238-2886; mperez04@sralab.org

Locations

United States, Illinois

Shirley Ryan AbilityLab; Recruiting

Chicago, Illinois, United States, 60611

Contact: Monica A Perez, PhD, PT 312-238-2886 mperez04@sralab.org

Sponsors and Collaborators

Shirley Ryan AbilityLab

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

• Principal Investigator: Monica A Perez, PhD, PT; Shirley Ryan AbilityLab

More Information

• Responsible Party: Monica Perez, Chair Arms + Hands Lab, Shirley Ryan AbilityLab
• ClinicalTrials.gov Identifier: NCT02446210
• Other Study ID Numbers: STU0020971; R01NS076589-01 ( U.S. NIH Grant/Contract )
• First Posted: May 18, 2015
• Last Update Posted: May 25, 2021
• Last Verified: May 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Monica Perez, Shirley Ryan AbilityLab:

SCI; Neural Control; Bilateral Movement; TMS

Additional relevant MeSH terms:

Spinal Cord Injuries; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System