Study Results
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View full resultsBasic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2016-03-01
2020-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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STDP
Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.
STDP
Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.
STDP + Training
Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation.
STDP
Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.
Training
The participant will be asked to perform exercises using their hands and arms.
Sham STDP + Training
Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. Motor training will follow stimulation.
Training
The participant will be asked to perform exercises using their hands and arms.
Sham STDP
Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times.
Multisite-STDP + Training
Prospective Single Cohort Multisite-Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation.
Training
The participant will be asked to perform exercises using their hands and arms.
Multisite-STDP
Paired stimulation will be given to the brain bilaterally, thoracic spine, and several peripheral nerve so that the messages are received at the spinal cord at predetermined time.
Interventions
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STDP
Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.
Training
The participant will be asked to perform exercises using their hands and arms.
Sham STDP
Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times.
Multisite-STDP
Paired stimulation will be given to the brain bilaterally, thoracic spine, and several peripheral nerve so that the messages are received at the spinal cord at predetermined time.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 ( 6 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
* 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.
18 Years
85 Years
ALL
Yes
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Martin Oudega, PhD
Role: PRINCIPAL_INVESTIGATOR
Edward Hines Jr. VA Hospital, Hines, IL
Locations
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Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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B1807-R
Identifier Type: -
Identifier Source: org_study_id
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