Improving Motor Function After Spinal Cord Injury

NCT ID: NCT01915095

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-09-01

Brief Summary

The goals of this study are to examine the physiology of Central Nervous System pathways contributing to the control of upper and lower extremity movements after SCI, and to promote the recovery of extremity movements by using non-invasive brain stimulation and motor training.

Detailed Description

This study will consist of electromyography (surface and intramuscular), peripheral nerve stimulation, and transcranial magnetic stimulation, electrical stimulation, of the hand, arm, leg, and foot representation of the primary motor cortex, as well as MRI scans of the brain. The investigators will examine the physiological measurements of upper and lower extremity muscles (such as in the first dorsal interosseous (FDI), biceps brachii (BIC), anterior deltoid (AD), tibialis anterior (TA), hamstring (HAMS) and quadriceps (QUAD)). This study may occur at the Miami Project to cure Paralysis at the University of Miami. The investigators will include subjects between the ages of 18 and 85, both healthy controls and individuals with chronic spinal cord injuries that occurred at least 6 months prior to recruitment. Both healthy controls and those with spinal cord injuries will be able to perform small hand and arm movements and small leg and foot movements. The primary outcome measures of this study are muscle responses to stimulation with magnetic pulses using TMS and electrical stimulation of a peripheral nerve in the arm or leg. The investigators propose to enhance the recovery of motor function by using new protocols of high frequency non-invasive repetitive TMS (rTMS) and motor training. Repetitive TMS will be used during hand, arm, leg and foot movements in a task-dependent manner to induce cortical plasticity and enhance voluntary output of the muscles associated with those movements. Second, rTMS will be applied in a task-dependent manner during a visuo-motor training task that also involves movements of the hands, arms, legs or feet.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Motor task+ Magnetic stimulation

Participants will be asked to complete a precision grip with the index and thumb finger at the same time as flexing or extending the wrist. magnetic stimulation to the brain will be administered and measurements will be taken during movement.

Group Type: ACTIVE_COMPARATOR

rTMS

Intervention Type: DEVICE

small magnetic pulses will be given to the brain in a non invasive manner.

Sham rTMS

Intervention Type: DEVICE

sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner

Motor Task

Intervention Type: OTHER

participants will be asked to perform specific motor tasks or movements with their fingers, hands, arms or legs.

rTMS/sham rTMS

Participant will be randomly assigned to one of 3 groups: repetitive transcranial magnetic stimulation (rTMS), sham (fake) rTMS, or sham (fake) rTMS over control brain area will be administered to the brain. the stimulation will be targeting finger and wrist muscles during movement.

Group Type: ACTIVE_COMPARATOR

rTMS

Intervention Type: DEVICE

small magnetic pulses will be given to the brain in a non invasive manner.

Sham rTMS

Intervention Type: DEVICE

sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner

Training + rTMS/ Sham rTMS

Participants will be asked to follow a target line on the computer as accurately as possible while performing precision grips or foot movement . Magnetic stimulation will be given during rest and movement.

Group Type: ACTIVE_COMPARATOR

rTMS

Intervention Type: DEVICE

small magnetic pulses will be given to the brain in a non invasive manner.

Sham rTMS

Intervention Type: DEVICE

sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner

Training

Intervention Type: OTHER

at the direction of the researcher the participant will be instructed to do repetitive motor movements with their arm, hand or leg. this is called training

Interventions

rTMS

small magnetic pulses will be given to the brain in a non invasive manner.

Intervention Type: DEVICE

Sham rTMS

sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner

Intervention Type: DEVICE

Training

at the direction of the researcher the participant will be instructed to do repetitive motor movements with their arm, hand or leg. this is called training

Intervention Type: OTHER

Motor Task

participants will be asked to perform specific motor tasks or movements with their fingers, hands, arms or legs.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Male and female Veterans and non Veterans with spinal cord injury at least 6 months after injury was sustained. The investigators also plan to enroll control subjects who do not have any history of spinal cord injury.

Participants who are unimpaired healthy controls:

• Male and females between ages 18-85 years
• Right handed
• Able to complete precision grips with both hands
• Able to complete full wrist flexion-extension bilaterally
• Able to walk unassisted
• Able to complete full ankle flexion-extension bilaterally

Participants who have had a spinal cord injury:

• Male and females between ages 18-85 years
• Chronic SCI ( 6 months of injury)
• Spinal Cord injury at or above L5
• The ability to produce a visible precision grip force with one hand
• Individuals who have the ability to pick up a small object (large paperclip) from a table independently
• Able to perform some small wrist flexion and extension (measured by a goniometer)
• The ability to perform a small visible contraction with dorsiflexor and hip flexor muscles
• No subjects will be excluded based on their race, religion, ethnicity, gender or HIV status.

Exclusion Criteria

• 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
• Metal plate in skull
• History of seizures
• Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold (see appendix 2)
• 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, MS, or herniated cervical disk
• Individuals with scalp shrapnel, cochlear implants, or aneurysm clips.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monica A Perez, PhD

Role: PRINCIPAL_INVESTIGATOR

Edward Hines Jr. VA Hospital, Hines, IL

Locations

Miami VA Healthcare System, Miami, FL

Miami, Florida, United States

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

B0815-R

Identifier Type: -

Identifier Source: org_study_id

NCT02701790

Identifier Type: -

Identifier Source: nct_alias