Spinal Cord InjuryNCT02451683
Corticospinal Function After Spinal Cord Injury
A study testing Electrophysiology Assessment of Time Domain, Electrophysiology Assessment of Location and Training with some stimulation in people with Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The investigator's overall goal is to develop new strategies to test optimization of Spike-timing-dependent plasticity (STDP) doses to maximize strategy to restore upper and lower-limb motor function in individuals with spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Electrophysiology Assessment of Time Domain, Electrophysiology Assessment of Location and Training with some stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2020to 30 Jan 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and females between 18-85 years,
- Chronic SCI (≥ 6 months post injury),
- Cervical injury at C8 or above,
- Intact or impaired but not absent innervations in dermatomes C6, C7, and C8 using the American Spinal Injury Association sensory scores, and
- Ability to reach and grasp a small object located at least 8 cm forward, above, and laterally without leaning forward with the trunk
- Male and females between 18-85 years,
- Right handed,
- Ability to reach and grasp a small object located at least 8 cm forward, above, and laterally without leaning forward with the trunk
Who cannot join
- Exclusion criteria for individuals with SCI and Healthy Controls:
- 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
Show all 12Show fewer
- 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
- 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.
- History of brain tumor and or brain infection
Trial locations and contacts
1 site in 1 country.
About this study
The investigator's overall goal is to develop new strategies to test optimization of Spike-timing-dependent plasticity (STDP) doses to maximize strategy to restore upper and lower-limb motor function in individuals with spinal cord injury (SCI). The investigator proposes to use modern electrophysiological methods to enhance the efficacy of residual corticospinal connections. Defining the neural basis by which corticospinal volleys generate muscle responses will provide crucial information required to maximize residual motor output. The investigator's specific goals are to: 1) determine the temporal and spatial organization of corticospinal volleys and motor cortical representations of upper-limb muscles after incomplete cervical SCI and 2) develop methodologies to promote recovery of function. The investigator's focus on reach and grasp movements because of their importance in daily life activities.
Read the detailed description
This study will determine the temporal organization of corticospinal volleys during reach and grasp movements. Multiple descending volleys in the corticospinal tract generate multiple peaks in muscle responses (indirect (I)-waves). I-waves are a mechanism by which corticospinal neurons are transynaptically activated at periodic intervals of ~1.5 ms. This periodic activation contributes to the recruitment of spinal motoneurons and generation of movement. we will use paired-TMS to examine I-waves in surface EMG recordings from upper-limb muscles during reach and grasp movements.
We will also identify motor cortical maps of upper-limb muscles involved in reach and grasp movements. We will use TMS guided by a frameless neuronavigation system to define the size and location of motor cortical maps of upper-limb muscles during reach and grasp movements. We will be able to determine overlaps and functional interactions between distal and proximal arm motor cortical representations. Our preliminary data shows that finger and biceps cortical maps largely overlap during reach and grasp movements in controls but considerable less in patients
- Conditions
- Spinal Cord Injury
- Being tested
- Electrophysiology Assessment of Time Domain, Electrophysiology Assessment of Location, Training with some 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.
Electrophysiology Assessment of Time DomainOther
Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability.
Electrophysiology Assessment of LocationOther
Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability
Training with some stimulationOther
motor task combined with real or sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Electrophysiology Assessment of Time Domain | Other | Assessment of electrophysiology in the time domain to examin temporal organization of corticospinal function Receives: Other: Electrophysiology Assessment of Time Domain; Other: Training with some stimulation |
| Electrophysiology Assessment of Location | Experimental | Assessment of electrophysiology to examine spatial organization of corticospinal function Receives: Other: Electrophysiology Assessment of Location; Other: Training with some stimulation |
| Training with some stimulation | Active comparator | Training with non-invasive stimulation and training with sham stimulation Receives: Other: Training with some stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper-limb motor function
measured by functional tests of hand/arm motor function
Measured: 5 months
Secondary outcomes (2)
Cortical Neurophysiological Outcome
measured by the maps area and overlap in millimeters
Measured: 5 months
Change in Sensorimotor Function
measured by upper-limb movements scale from 1(dependent) to 7 (independent).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study start12 Oct 2020
- Primary completion31 Dec 2025
- Study completion30 Jan 2026
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Perez, Shirley Ryan AbilityLab
- Investigators
- Monica Perez, PT PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451683
- Sponsor's protocol ID
- STU00210458
- Other IDs
- R01NS090622-01
- Status last verified
- Feb 2026
- First submitted
- 11 May 2015
- Last updated
- 3 Mar 2026
- 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 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticospinal Function After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02451683
- Acronym / sponsor ID
- STU00210458
- Conditions
- Spinal Cord Injury
- Keywords
- SCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 22 May 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.
The investigator's overall goal is to develop new strategies to test optimization of Spike-timing-dependent plasticity (STDP) doses to maximize strategy to restore upper and lower-limb motor function in individuals with spinal cord injury (SCI). The investigator proposes to use modern electrophysiological methods to enhance the efficacy of residual corticospinal connections. Defining the neural basis by which corticospinal volleys generate muscle responses will provide crucial information required to maximize residual motor output. The investigator's specific goals are to: 1) determine the temporal and spatial organization of corticospinal volleys and motor cortical representations of upper-limb muscles after incomplete cervical SCI and 2) develop methodologies to promote recovery of function. The investigator's focus on reach and grasp movements because of their importance in daily life activities.
Detailed description
This study will determine the temporal organization of corticospinal volleys during reach and grasp movements. Multiple descending volleys in the corticospinal tract generate multiple peaks in muscle responses (indirect (I)-waves). I-waves are a mechanism by which corticospinal neurons are transynaptically activated at periodic intervals of ~1.5 ms. This periodic activation contributes to the recruitment of spinal motoneurons and generation of movement. we will use paired-TMS to examine I-waves in surface EMG recordings from upper-limb muscles during reach and grasp movements.
We will also identify motor cortical maps of upper-limb muscles involved in reach and grasp movements. We will use TMS guided by a frameless neuronavigation system to define the size and location of motor cortical maps of upper-limb muscles during reach and grasp movements. We will be able to determine overlaps and functional interactions between distal and proximal arm motor cortical representations. Our preliminary data shows that finger and biceps cortical maps largely overlap during reach and grasp movements in controls but considerable less in patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electrophysiology Assessment of Time Domain | Other | Other: Electrophysiology Assessment of Time Domain, Other: Training with some stimulationAssessment of electrophysiology in the time domain to examin temporal organization of corticospinal function |
| Electrophysiology Assessment of Location | Experimental | Other: Electrophysiology Assessment of Location, Other: Training with some stimulationAssessment of electrophysiology to examine spatial organization of corticospinal function |
| Training with some stimulation | Active comparator | Other: Training with some stimulationTraining with non-invasive stimulation and training with sham stimulation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and females between 18-85 years,
- Right handed,
- Ability to reach and grasp a small object located at least 8 cm forward, above, and laterally without leaning forward with the trunk
Key exclusion criteria (12 listed)
- Exclusion criteria for individuals with SCI and Healthy Controls:
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 |
|---|---|---|
| Electrophysiology Assessment of Time DomainKinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability. | Other | Electrophysiology Assessment of Time Domain |
| Electrophysiology Assessment of LocationKinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability | Other | Electrophysiology Assessment of Location |
| Training with some stimulationmotor task combined with real or sham stimulation | Other | Electrophysiology Assessment of Location, Electrophysiology Assessment of Time Domain, Training with some stimulation |
Primary outcome
Upper-limb motor function
Time frame: 5 months
measured by functional tests of hand/arm motor function
2 secondary outcomes
Cortical Neurophysiological Outcome
Time frame: 5 months
Change in Sensorimotor Function
Time frame: 5 months
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 3 Mar 2026.
- Individual participant dataSharing planned: No
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Effect of TMS on Neuropathic Pain for Patients With Spinal Cord Injury
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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 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 study testing Electrophysiology Assessment of Time Domain, Electrophysiology Assessment of Location and Training with some 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 8 inclusion and 12 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 3 Mar 2026. 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.
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?
Upper-limb motor function (time frame: 5 months). 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 3 Mar 2026.