Lower Limb Function After Spinal Cord Injury
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ClinicalTrials.gov Identifier: NCT02635893 |
Recruitment Status
:
Recruiting
First Posted
: December 21, 2015
Last Update Posted
: November 8, 2017
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Condition or disease | Intervention/treatment | Phase |
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Spinal Cord Injury | Drug: D-Cycloserine Drug: Placebo Other: Training Other: Stimulation Other: Placebo Stimulation | Phase 4 |
This study plans to examine plasticity in corticospinal synapses of lower-limb muscles. it has been demonstrated that plasticity elicited at corticospinal synapses in the spinal cord result in enhancements in electromyographic (EMG) and force activity in upper-limb muscles. The first step in this proposal is to determine if synaptic plasticity can be elicited in corticospinal projections targeting lower-limb muscles in humans with SC.
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
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 257 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Corticospinal Excitability of Leg Muscles After Spinal Cord Injury |
Study Start Date : | October 2015 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | October 2020 |

Arm | Intervention/treatment |
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Active Comparator: D-Cycloserine/Placebo + Stimulation
Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation.
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Drug: D-Cycloserine
100 mg of Seromycin by mouth will be administered
Other Name: Seromycin
Drug: Placebo
placebo pill will be administered instead of medication by mouth
Other Name: Placebo Drug
Other: Stimulation
magnetic stimulation and electrical stimulation may be applied
|
Active Comparator: 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.
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Drug: D-Cycloserine
100 mg of Seromycin by mouth will be administered
Other Name: Seromycin
Drug: Placebo
placebo pill will be administered instead of medication by mouth
Other Name: Placebo Drug
Other: Training
walking around a designated track at different speeds both forward and backward
Other: Stimulation
magnetic stimulation and electrical stimulation may be applied
|
Active Comparator: 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.
|
Drug: D-Cycloserine
100 mg of Seromycin by mouth will be administered
Other Name: Seromycin
Other: Training
walking around a designated track at different speeds both forward and backward
Other: Stimulation
magnetic stimulation and electrical stimulation may be applied
Other: Placebo Stimulation
this is a fake stimulation that is administered but will be unknow to the subject.
|
- Changes in motor evoked potential size [ Time Frame: 30 minutes before and 30 minutes after intervention ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
-
4. Inclusion criteria for individuals with SCI:
- Male and females between ages 18-85 years of age
- 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
Inclusion criteria for healthy controls:
- Male and females between ages 18-85 years of age
- Able to walk and complete lower-limb tests with both legs
Exclusion Criteria:
Exclusion criteria for individuals with SCI
- 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 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.
Exclusion criteria for healthy controls:
- 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.

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): NCT02635893
Contact: Monica Perez, PT PhD | 305-243-7119 | perezmo@miami.edu | |
Contact: Toshiki Tazoe, PhD | 305-243-8771 | txt185@miami.edu |
United States, Florida | |
The Miami Project to Cure Paralysis | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Monica Perez, PT PhD 305-243-7119 perezmo@miami.edu | |
Contact: Toshiki Tazoe, PhD 305-243-8771 txt185@miami.edu |
Principal Investigator: | Monica A Perez, PT, Phd | University of Miami |
Responsible Party: | Monica Perez, Associate Professor, University of Miami |
ClinicalTrials.gov Identifier: | NCT02635893 History of Changes |
Other Study ID Numbers: |
20150605 |
First Posted: | December 21, 2015 Key Record Dates |
Last Update Posted: | November 8, 2017 |
Last Verified: | November 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Monica Perez, University of Miami:
SCI |
Additional relevant MeSH terms:
Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Cycloserine Anti-Infective Agents, Urinary |
Anti-Infective Agents Renal Agents Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |