Recruiting

Observational Study

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT02446210

Conditions

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Magstim 200

Digitimer electrical stimulator

Study Details

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

Study ID

NCT02446210

Start date

Jan 28, 2021

Status verified date

May, 2021

Completion date

Jan 27, 2023

Anticipated

Primary completion date

Jan 27, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

514 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Healthy Controls Group

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

active comparator: Spinal Cord Injury Group

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

Interventions

Magstim 200

Transcranial Magnetic Stimulation

Digitimer electrical stimulator

Transcranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation

Primary outcome measure

  • Number of participants with reduced motor cortical excitability [ Time Frame: 5 months ]

Central Contacts and Locations

Central contacts

Monica A Perez, PhD, PT

312-238-2886mperez04@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Monica A Perez, PhD, PT

312-238-2886mperez04@sralab.org

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

May 25, 2021

Last verified

May, 2021

Keywords

  • SCI
  • Neural Control
  • Bilateral Movement
  • TMS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2021-05-25.