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Grasping Function After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03447509
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
University of Miami
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The overall goals of this proposal are to examine the contribution of physiological pathways to the control of grasping behaviors after cervical SCI, and to maximize the recovery of grasping by using tailored non-invasive brain stimulation and acoustic startle protocols with motor training. The investigators propose to study two basic grasping behaviors, which are largely used in most daily-life activities: a precision grip and a power grip

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: iTMS Other: Motor Task Device: Sham iTMS Other: Training Not Applicable

Detailed Description:

Grasping behaviors, which are essential for daily-life functions, are largely impaired in individuals with cervical spinal cord injury (SCI). Although rehabilitative interventions have shown success in improving the ability to grasp following injury their overall effects remain limited. The goals of this proposal are to examine the contribution of physiological pathways to the control of grasping behaviors after cervical SCI, and to maximize the recovery of grasping by using tailored non-invasive stimulation protocols with motor training. The investigators propose to study two basic grasping behaviors: a precision grip and a power grip. These behaviors are crucial because they provide the basis for a number human prehensile manipulations and are also necessary skills for eating, writing, dressing, and many other functions. Thus, the study results may have a direct impact on the quality of life for Veterans and their caregivers by enhancing their independence and level of care.

In Aim 1, the investigators will investigate the contribution of corticospinal and brainstem pathways to the control of hand muscles involved in precision and power grip after cervical SCI. Transcranial magnetic stimulation (TMS) will be used to examine transmission in corticospinal and intracortical pathways targeting finger muscles and an acoustic startle stimulus with and without TMS will be used to examine the contribution from brainstem pathways. In Aim 2, the investigators propose to enhance the recovery of grasping by using novel tailored protocols of non-invasive repetitive TMS targeting late indirect (I) descending volleys (iTMS) and an acoustic startle stimuli. iTMS and startle will be used during precision and power grip movements in a task-dependent manner to induce cortical and subcortical plasticity and enhance voluntary output of hand muscles. Later, iTMS and startle will be applied in a task-dependent manner during a motor training task that involves precision and power grip. These unique approaches aim at promoting neuroplasticity during functionally relevant grasping movements has not been used before.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Magnetic Stimulation
Masking: Single (Participant)
Masking Description: participants will not know if they receive real or sham stimulation
Primary Purpose: Treatment
Official Title: Grasping Function After Spinal Cord Injury
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm 1
Examine physiological mechanisms contributing to the control of precision and power grip behaviors. To accomplish this aim the investigators propose to complete one main experiment. The investigators will test the hypotheses that there are two fundamentally distinct modes of hand operation after SCI. One involves brainstem pathways, and permits whole-hand 'power grip', while the other involves corticospinal and motor cortical connections, and allows a wide range of fractionated finger movements (precision grip) after SCI. Measurements of corticospinal, reticulospinal, and motoneuron excitability will be tested during index finger abduction, precision and power grip.
Device: iTMS
small magnetic pulse 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, and arms.

Active Comparator: Arm 2
To accomplish this aim the investigators propose to complete one main experiment. The investigators will use iTMS and an acoustic startle stimuli to test the hypothesis that induced-plasticity protocols (iTMS and startle stimuli) will enhance EMG and force output in hand muscles during grasping. In a randomized sham crossover design, SCI and controls will be assigned to two groups: (1) iTMS applied during precision and power grip (two randomized sessions), and (2) startle applied during precision and power grip (two randomized sessions).
Device: iTMS
small magnetic pulse will be given to the brain in a non invasive manner

Active Comparator: Arm 3
To accomplish this aim the investigators propose to complete one main experiment. The investigators will combine iTMS and acoustic startle with precision and power grip training to test the hypothesis that 'precision and power grip training outcomes will be enhanced by iTMS and startle induced plasticity'. In a randomized sham controlled design, SCI and control subjects will be assigned to: training+iTMS and training+sham iTMS and training+startle and training+sham startle.
Device: iTMS
small magnetic pulse will be given to the brain in a non invasive manner

Device: Sham iTMS
Sham or fake stimulation 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 or hand. This is called training.




Primary Outcome Measures :
  1. Changes in amplitude of Motor evoked potential size [ Time Frame: post treatment at minute 0, minute 10, minute30, minute 60. ]
    at the stated minute interval measurements are reassessed to effect


Secondary Outcome Measures :
  1. Grip Strength and 9-hole peg test [ Time Frame: post treatment at minute 0, minute 10, minute30, minute 60. ]
    At the stated minute interval measurements are reassessed to effect, force is measured during a grip task as muscle electrical activity (electromyography) is recorded in millivolts (mV). The 9-hole peg test is a dexterity measure, estimated as the time required to complete the task (seconds).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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
  • SCI ( 2 months of injury)
  • Spinal Cord injury at or above L5
  • The ability to produce a visible precision grip force with one hand
  • Able to perform some small wrist flexion and extension
  • The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles
  • No subjects will be excluded based on their race, religion, ethnicity, gender or HIV status.
  • ASIA A,B,C, or D

Exclusion Criteria:

Exclusion criteria for enrollment For SCI and Healthy Control Subjects (4-8 exclusion for non-invasive brain stimulation only):

  • 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 disk
  • Individuals with scalp shrapnel, cochlear implants, or aneurysm clips.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447509


Contacts
Contact: Francisco D Benavides, MD (305) 575-7000 ext 3179 fbenavides@med.miami.edu
Contact: Monica A Perez, PhD (412) 383-6563 perezmo@miami.edu

Locations
United States, Florida
Miami VA Healthcare System, Miami, FL Recruiting
Miami, Florida, United States, 33125
Contact: Francisco D Benavides, MD    (305) 575-7000 ext 3179    fbenavides@med.miami.edu   
Principal Investigator: Monica Alicia Perez, PhD         
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

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03447509     History of Changes
Other Study ID Numbers: B2474-R
1201950-2 ( Other Identifier: Miami VA Healthcare System )
20180300 ( Other Identifier: University of Miami )
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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