Neural Control of Bilateral Movements After SCI

Neural Control of Bilateral Hand, Arm, and Leg Movements After Spinal Cord Injury

Patrocinadores

Patrocinador principal: Shirley Ryan AbilityLab

Colaborador: National Institute of Neurological Disorders and Stroke (NINDS)

Fuente Shirley Ryan AbilityLab
Resumen breve

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.

Descripción detallada

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.

Estado general Not yet recruiting
Fecha de inicio March 2020
Fecha de Terminación October 2020
Fecha de finalización primaria July 2020
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Number of participants with reduced motor cortical excitability 5 months
Resultado secundario
Medida Periodo de tiempo
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
Inscripción 514
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Magstim 200

Descripción: Transcranial Magnetic Stimulation

Tipo de intervención: Device

Nombre de intervención: Digitimer electrical stimulator

Descripción: Transcranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation

Otro nombre: Electrical stimulation

Elegibilidad

Criterios:

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 L5 (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.

Género: All

Edad mínima: 18 Years

Edad máxima: 85 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Monica A Perez, PhD, PT Principal Investigator Univeraity of Miami
Contacto general

Apellido: Monica A Perez, PhD, PT

Teléfono: 305-243-7119

Email: [email protected]

Ubicación
Instalaciones: Contacto: Shirley Ryan AbilityLab Monica A Perez, PhD, PT 312-238-2886 [email protected]
Ubicacion Paises

United States

Fecha de verificación

January 2020

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Shirley Ryan AbilityLab

Nombre completo del investigador: Monica Perez

Título del investigador: Chair Arms + Hands Lab

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Healthy Controls Group

Tipo: Active Comparator

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

Etiqueta: Spinal Cord Injury Group

Tipo: Active Comparator

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

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Crossover Assignment

Propósito primario: Diagnostic

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov