Grasping Function After Spinal Cord Injury
|ClinicalTrials.gov Identifier: NCT03447509|
Recruitment Status : Not yet recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Device: iTMS Other: Motor Task Device: Sham iTMS Other: Training||Not Applicable|
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|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Magnetic Stimulation|
|Masking Description:||participants will not know if they receive real or sham stimulation|
|Official Title:||Grasping Function After Spinal Cord Injury|
|Estimated Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||April 1, 2022|
|Estimated Study Completion Date :||April 1, 2022|
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.
small magnetic pulse will be given to the brain in a non invasive mannerOther: 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).
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.
small magnetic pulse will be given to the brain in a non invasive mannerDevice: Sham iTMS
Sham or fake stimulation will be given to the brain in a non invasive mannerOther: 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.
- 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
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447509
|Contact: Francisco D Benavides, MD||(305) 575-7000 ext email@example.com|
|Contact: Monica A Perez, PhD||(412) firstname.lastname@example.org|
|United States, Florida|
|Miami VA Healthcare System, Miami, FL||Not yet recruiting|
|Miami, Florida, United States, 33125|
|Contact: Francisco D Benavides, MD (305) 575-7000 ext 3179 email@example.com|
|Principal Investigator: Monica Alicia Perez, PhD|
|Principal Investigator:||Monica Alicia Perez, PhD||Miami VA Healthcare System, Miami, FL|