Neuroplasticity After Spinal Cord Injury

NCT02446210 | Unknown

• 2 other identifiers: STU0020971R01NS076589-01
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

SCI; Neural Control; Bilateral Movement; TMS

Outcome Measures

Primary Outcomes (1)

• Number of participants with reduced motor cortical excitability

  Measured by Electroencephalogram/Electromyography and Electromyography/Electromyography coherence

  5 months

Secondary Outcomes (2)

• Number of participants with enhance voluntary motor output in upper limbs

  5 months

• Number of participants with enhance voluntary motor output in lower limbs

  5 months

Study Arms (2)

Healthy Controls Group

ACTIVE COMPARATOR

Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation

Device: Magstim 200; Device: Digitimer electrical stimulator

Spinal Cord Injury Group

ACTIVE COMPARATOR

Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation

Device: Magstim 200; Device: Digitimer electrical stimulator

Interventions

Magstim 200 DEVICE

Transcranial Magnetic Stimulation

Healthy Controls Group; Spinal Cord Injury Group

Digitimer electrical stimulator DEVICE

Transcranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation

Also known as: Electrical stimulation

Healthy Controls Group; Spinal Cord Injury Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Monica A Perez, PhD, PT

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica A Perez, PhD, PT

CONTACT

312-238-2886; mperez04@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Arms + Hands Lab

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 18, 2015
• Study Start: January 28, 2021
• Primary Completion: January 27, 2022
• Study Completion: January 27, 2023
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

US (1)