Improving Motor Function After Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by VA Office of Research and Development
Sponsor:
Collaborator:
University of Miami
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01915095
First received: July 19, 2013
Last updated: May 6, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Spinal Cord Injury
Device: rTMS
Device: Sham rTMS
Other: Training
Other: Motor Task

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Enhancement of Hand Motor Function After Cervical Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • changes in amplitude of motor evoked potential [ Time Frame: post treatment at minute 0, minute 10, minute 30, minute 60 ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Device: rTMS
small magnetic pulses will be given to the brain in a non invasive manner.
Device: Sham rTMS
sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner
Other: Motor Task
participants will be asked to perform specific motor tasks or movements with their fingers, hands, arms or legs.
Active Comparator: 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.
Device: rTMS
small magnetic pulses will be given to the brain in a non invasive manner.
Device: Sham rTMS
sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner
Active Comparator: 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.
Device: rTMS
small magnetic pulses will be given to the brain in a non invasive manner.
Device: Sham rTMS
sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner
Other: 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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

Exclusion criteria for enrollment For SCI and Healthy Control Subjects (for stimulation):

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915095

Contacts
Contact: Sarah Lehmann, RN BA (305) 575-7000 ext 5284 sarah.lehmann@va.gov
Contact: Toshiki Tazoe, PhD (305) 243-7127 txt185@miami.edu

Locations
United States, Florida
Miami VA Healthcare System, Miami, FL Recruiting
Miami, Florida, United States, 33125
Contact: Sarah Lehmann, RN BA    (305) 575-7000 ext 5284    sarah.lehmann@va.gov   
Principal Investigator: Monica Alicia Perez, PhD         
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Active, not recruiting
Pittsburgh, Florida, United States, 15240
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
VA Office of Research and Development
University of Miami
Investigators
Principal Investigator: Monica Alicia Perez, PhD Miami VA Healthcare System, Miami, FL
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01915095     History of Changes
Obsolete Identifiers: NCT02701790
Other Study ID Numbers: B0815-R  20151113 
Study First Received: July 19, 2013
Last Updated: May 6, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
spinal cord injury
neural control
motor function
hand movement

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 28, 2016