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Grasping Function After Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iTMS
Motor Task
Sham iTMS
Training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal cord injury, neural control, motor function, hand movement

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Participants who have had a spinal cord injury:

  • Male and females between ages 18-85 years
  • Chronic SCI (> 1 year post injury)
  • Spinal Cord injury at or above C8
  • The ability to produce a visible precision grip force with one hand
  • Able to perform some small wrist flexion and extension
  • 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
  • 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

Sites / Locations

  • Edward Hines Jr. VA Hospital, Hines, ILRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Experiment 1a

Experiment 1b

Experiment 2

Arm Description

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.

To accomplish this aim the investigators propose to complete one main experiment. The investigators will use iTMS and/or 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).

To accomplish this aim the investigators propose to complete one main experiment. The investigators will combine iTMS and/or 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.

Outcomes

Primary Outcome Measures

Changes in amplitude of Motor evoked potential size
At the stated minute interval TMS measurements are reassessed.

Secondary Outcome Measures

Grip Strength and 9-hole peg test
At the stated minute interval the following measurements are reassessed: Force is measured during a grip task as muscle electrical activity (electromyography) is recorded in millivolts (mV) and 9-hole peg test is a dexterity measure, estimated as the time required to complete the task (seconds).

Full Information

First Posted
January 31, 2018
Last Updated
July 26, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03447509
Brief Title
Grasping Function After Spinal Cord Injury
Official Title
Grasping Function After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal cord injury, neural control, motor function, hand movement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Magnetic Stimulation and Acoustic Startle
Masking
Participant
Masking Description
Participants will not know if they receive real or sham Stimulation and/or real or sham Startle
Allocation
Randomized
Enrollment
175 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiment 1a
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experiment 1b
Arm Type
Active Comparator
Arm Description
To accomplish this aim the investigators propose to complete one main experiment. The investigators will use iTMS and/or 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).
Arm Title
Experiment 2
Arm Type
Active Comparator
Arm Description
To accomplish this aim the investigators propose to complete one main experiment. The investigators will combine iTMS and/or 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.
Intervention Type
Device
Intervention Name(s)
iTMS
Intervention Description
Small magnetic pulse will be given to the brain in a non invasive manner.
Intervention Type
Other
Intervention Name(s)
Motor Task
Intervention Description
Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.
Intervention Type
Device
Intervention Name(s)
Sham iTMS
Intervention Description
Sham or fake stimulation will be given to the brain in a non invasive manner.
Intervention Type
Other
Intervention Name(s)
Training
Intervention Description
The participant will be instructed to do repetitive motor movements with their arm or hand.
Primary Outcome Measure Information:
Title
Changes in amplitude of Motor evoked potential size
Description
At the stated minute interval TMS measurements are reassessed.
Time Frame
Post treatment at minute 0, minute 10, minute30, minute 60.
Secondary Outcome Measure Information:
Title
Grip Strength and 9-hole peg test
Description
At the stated minute interval the following measurements are reassessed: Force is measured during a grip task as muscle electrical activity (electromyography) is recorded in millivolts (mV) and 9-hole peg test is a dexterity measure, estimated as the time required to complete the task (seconds).
Time Frame
Post treatment at minute 0, minute 10, minute30, minute 60.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 Participants who have had a spinal cord injury: Male and females between ages 18-85 years Chronic SCI (> 1 year post injury) Spinal Cord injury at C8 or above Intact or impaired but not absent innervations in dermatomes C6. C7 and C8 during light touch and pin prick stimulus using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores The ability to produce a visible precision grip force with one hand Able to perform some small wrist flexion and extension 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 Pacemaker Metal plate in skull History of seizures Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica A Perez, PhD
Phone
(312) 238-2886
Email
mperez04@sralab.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica A Perez, PhD
Organizational Affiliation
Edward Hines Jr. VA Hospital, Hines, IL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward Hines Jr. VA Hospital, Hines, IL
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141-3030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Morrow, BA
Phone
312-238-7794
Email
Meghan.Morrow@va.gov
First Name & Middle Initial & Last Name & Degree
Monica A Perez, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Grasping Function After Spinal Cord Injury

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