Spinal Cord InjuryPhase 4NCT02635893
Lower Limb Function After Spinal Cord Injury
A Phase 4 study testing D-Cycloserine, Training and Stimulation in people with Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
This is a randomized, experimental study that examines the physiology of central nervous system pathways contributing to the control of bilateral movements in individuals with spinal cord injuries and promotes the recovery of lower-limb motor function through the use of stimulation and locomotor training. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- D-Cycloserine, Training and Stimulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 257 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2019to 11 Apr 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Shirley Ryan Ability Lab
Chicago, Illinois, 60611
About this study
This is a randomized, experimental study that examines the physiology of central nervous system pathways contributing to the control of bilateral movements in individuals with spinal cord injuries and promotes the recovery of lower-limb motor function through the use of stimulation and locomotor training.
Read the detailed description
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 SCI.
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
- Spinal Cord Injury
- Being tested
- D-Cycloserine, Placebo, Training, Stimulation, Placebo Stimulation
- Keywords
- SCI
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-CycloserineDrug
Also called Seromycin
100 mg of Seromycin by mouth will be administered
PlaceboDrug
Also called Placebo Drug
placebo pill will be administered instead of medication by mouth
TrainingOther
walking around a designated track at different speeds both forward and backward
StimulationOther
magnetic stimulation and electrical stimulation may be applied
Placebo StimulationOther
this is a fake stimulation that is administered but will be unknow to the subject.
| Study group | Role | What they receive |
|---|---|---|
| D-Cycloserine/Placebo + Stimulation | Active comparator | Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation. Receives: Drug: D-Cycloserine; Drug: Placebo; Other: Stimulation |
| Training+Med/Placebo+Stimulation | Active comparator | Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation followed by training. Receives: Drug: D-Cycloserine; Drug: Placebo; Other: Training; Other: Stimulation |
| Training+Med+Stimulation/Placebo Stim | Active comparator | Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation or placebo stimulation followed by training. Receives: Drug: D-Cycloserine; Other: Training; Other: Stimulation; Other: Placebo Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in motor evoked potential size
Measured: 30 minutes before and 30 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study start21 Jun 2019
- Primary completion9 Mar 2021
- Study completion11 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Monica Perez, Shirley Ryan AbilityLab
- Investigators
- Monica A Perez, PT, Phd, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635893
- Sponsor's protocol ID
- 20150605
- Status last verified
- Jun 2021
- First submitted
- 11 Dec 2015
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Limb Function After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02635893
- Acronym / sponsor ID
- 20150605
- Conditions
- Spinal Cord Injury
- Keywords
- SCI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 11 Apr 2021 (actual)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, experimental study that examines the physiology of central nervous system pathways contributing to the control of bilateral movements in individuals with spinal cord injuries and promotes the recovery of lower-limb motor function through the use of stimulation and locomotor training.
Detailed description
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 SCI.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| D-Cycloserine/Placebo + Stimulation | Active comparator | Drug: D-Cycloserine, Drug: Placebo, Other: StimulationParticipant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation. |
| Training+Med/Placebo+Stimulation | Active comparator | Drug: D-Cycloserine, Drug: Placebo, Other: Training, Other: StimulationParticipant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation followed by training. |
| Training+Med+Stimulation/Placebo Stim | Active comparator | Drug: D-Cycloserine, Other: Training, Other: Stimulation, Other: Placebo StimulationParticipant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation or placebo stimulation followed by training. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 4. Inclusion criteria for individuals with SCI:
- Male and females between ages 18-85 years of age
- Able to walk and complete lower-limb tests with both legs
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-CycloserineAlso: Seromycin100 mg of Seromycin by mouth will be administered | Drug | D-Cycloserine/Placebo + Stimulation, Training+Med+Stimulation/Placebo Stim, Training+Med/Placebo+Stimulation |
| PlaceboAlso: Placebo Drugplacebo pill will be administered instead of medication by mouth | Drug | D-Cycloserine/Placebo + Stimulation, Training+Med/Placebo+Stimulation |
| Trainingwalking around a designated track at different speeds both forward and backward | Other | Training+Med+Stimulation/Placebo Stim, Training+Med/Placebo+Stimulation |
| Stimulationmagnetic stimulation and electrical stimulation may be applied | Other | D-Cycloserine/Placebo + Stimulation, Training+Med+Stimulation/Placebo Stim, Training+Med/Placebo+Stimulation |
| Placebo Stimulationthis is a fake stimulation that is administered but will be unknow to the subject. | Other | Training+Med+Stimulation/Placebo Stim |
Primary outcome
Changes in motor evoked potential size
Time frame: 30 minutes before and 30 minutes after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica A Perez, PT, Phd principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing D-Cycloserine, Training and Stimulation in people with Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in motor evoked potential size (time frame: 30 minutes before and 30 minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.