Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
257 participants
INTERVENTIONAL
2019-06-21
2021-04-11
Brief Summary
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Detailed Description
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We will also study methods to strengthen corticospinal plasticity to promote recovery of leg clearance during training. We will use two novel strategies to enhance plasticity in corticospinal synapses of lower-limb muscles after SCI: a). administration of an N-methyl-D-aspartate (NMDA) receptor agonist (i.e. D-cycloserine), and b). Combine NMDA-induced corticospinal plasticity with training (2D lower limb training and locomotor training. Corticospinal synaptic plasticity is thought to depend on activation of NMDA receptors and D-cycloserine enhances motor skill behaviors in animals and humans will be enhanced by NMDA-induced corticospinal plasticity. An important strength of this aim is the combination of training and strategies that aimed at enhancing the synaptic efficacy of residual corticospinal projections. Training effects on physiological pathways will be explored and correlated with locomotor function
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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D-Cycloserine/Placebo + Stimulation
Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation.
D-Cycloserine
100 mg of Seromycin by mouth will be administered
Placebo
placebo pill will be administered instead of medication by mouth
Stimulation
magnetic stimulation and electrical stimulation may be applied
Training+Med/Placebo+Stimulation
Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation followed by training.
D-Cycloserine
100 mg of Seromycin by mouth will be administered
Placebo
placebo pill will be administered instead of medication by mouth
Training
walking around a designated track at different speeds both forward and backward
Stimulation
magnetic stimulation and electrical stimulation may be applied
Training+Med+Stimulation/Placebo Stim
Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation or placebo stimulation followed by training.
D-Cycloserine
100 mg of Seromycin by mouth will be administered
Training
walking around a designated track at different speeds both forward and backward
Stimulation
magnetic stimulation and electrical stimulation may be applied
Placebo Stimulation
this is a fake stimulation that is administered but will be unknow to the subject.
Interventions
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D-Cycloserine
100 mg of Seromycin by mouth will be administered
Placebo
placebo pill will be administered instead of medication by mouth
Training
walking around a designated track at different speeds both forward and backward
Stimulation
magnetic stimulation and electrical stimulation may be applied
Placebo Stimulation
this is a fake stimulation that is administered but will be unknow to the subject.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* SCI ( ≥1 month of injury)
* ASIA A, B,C and D
* SCI above L5
* Able to perform a visible contraction with dorsiflexor and hip flexor muscles (allowing testing of largely impaired patients)
* Able to ambulate a few steps with or without an assistive device
* Male and females between ages 18-85 years of age
* Able to walk and complete lower-limb tests with both legs
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 such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants.
* Pregnant females, and
* Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida or herniated cervical disk.
* Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease,
* Any debilitating disease that causes 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 such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants.
* Pregnant females, and
* Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida or herniated cervical disk.
18 Years
85 Years
ALL
Yes
Sponsors
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The Craig H. Neilsen Foundation
OTHER
Shirley Ryan AbilityLab
OTHER
Responsible Party
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Monica Perez
Chair Arms + Hands Lab
Principal Investigators
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Monica A Perez, PT, Phd
Role: PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab
Locations
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The Shirley Ryan Ability Lab
Chicago, Illinois, United States
Countries
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Other Identifiers
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20150605
Identifier Type: -
Identifier Source: org_study_id
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