Spinal Cord InjuryNCT02446210
Neuroplasticity After Spinal Cord Injury
A study testing Magstim 200 and Digitimer electrical stimulator in people with Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The long-term goal is to acquire scientific knowledge that can be used to develop mechanistic-driven intervention strategies aiming at restoring upper and lower-limb motor function in individuals with cervical or thoracic spinal cord injury (SCI). 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?
- Magstim 200 and Digitimer electrical stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2021to 27 Jan 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and females between ages 18-85 years
- SCI (≥1 month after injury)
- Cervical, thoracic or lumbar injury above L2 (tetraplegia)Intact (level 2) or impaired (level 1) but not absent (level 0) lower motor neuron innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the American Spinal Injury Association (ASIA) sensory scores (12)
- The ability to produce a visible precision grip force with both hands
- Individuals who have the ability to pick up a small object (large paperclip) from a table independently
- Ability to perform 30° or more of elbow flexion and extension.
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- The ability to perform a visible contraction with dorsiflexor and hip flexor muscles
- The ability to ambulate a few steps with or without an assistive device
- Male and females between ages 18-85 years
- Right handed
- Able to complete precision grips with both hands
- Able to complete full elbow flexion-extension with both arms.
- Able to walk and complete lower-limb tests with both legs.
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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Monica A Perez, PhD, PT, 312-238-2886, mperez04@sralab.org
About this study
Official title: Targeted Neuroplasticity After Spinal Cord Injury
The long-term goal is to acquire scientific knowledge that can be used to develop mechanistic-driven intervention strategies aiming at restoring upper and lower-limb motor function in individuals with cervical or thoracic spinal cord injury (SCI). The proposed project will examine cortical, corticospinal, and spinal contribution to bilateral hand and arm muscle activity during bilateral movements and spinal contributions to lower limb muscle activity. By comparing changes in different sites within the Central Nervous System (CNS), the investigators may also identify key mechanisms that might be differentially affected by the injury, plasticity, and training.
Read the detailed description
If the participant qualifies to take part in this research study, they will be asked to participate in 15-190 study visits,to complete the experimental procedures. These procedures have been broken up into "Phases" and will be completed in any order. Phase I and Phase IIa includes 2-30 total visits - approximately 2-3 hours each to measure arm and finger strength and ability to move. Phase IIb includes 2-30 total visits - approximately 2-3 hours each, to measure leg strength and ability to move. Phase IIIa includes up to 40 total visits - approximately 2 hours each, the investigator will again evaluate the participant's ability to use both arms. The participant will be asked to complete a series of tasks such as stacking checkers, turning over cards, squeeze a device to determine how strong their grip is, and see how well they are able to feel sensations on the surface of their skin. The investigators will complete these assessments at pre-determined times during the study participation. Phase IIIb includes up to 40 total visits - approximately 2 hours each, the investigator will again evaluate the participant's ability to use both legs. Assessments of the participant's legs will include walking around the lab space, how well they can bend their ankles and hips, and how well they are able to feel sensations on the surface of the participant's skin.
- Conditions
- Spinal Cord Injury
- Being tested
- Magstim 200, Digitimer electrical stimulator
- Keywords
- SCI, Neural Control, Bilateral Movement, TMS
- 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.
Magstim 200Device
Transcranial Magnetic Stimulation
Digitimer electrical stimulatorDevice
Also called Electrical stimulation
Transcranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls Group | Active comparator | Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation Receives: Device: Magstim 200; Device: Digitimer electrical stimulator |
| Spinal Cord Injury Group | Active comparator | Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation Receives: Device: Magstim 200; Device: Digitimer electrical stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with reduced motor cortical excitability
Measured by Electroencephalogram/Electromyography and Electromyography/Electromyography coherence
Measured: 5 months
Secondary outcomes (2)
Number of participants with enhance voluntary motor output in upper limbs
Measured by spike-timing-dependent plasticity
Measured: 5 months
Number of participants with enhance voluntary motor output in lower limbs
Measured by spike-timing-dependent plasticity
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 posted18 May 2015 (estimated)
- Study start28 Jan 2021
- Primary completion27 Jan 2022 (estimated)
- Study completion27 Jan 2023 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 514 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Monica Perez, Shirley Ryan AbilityLab
- Investigators
- Monica A Perez, PhD, PT, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446210
- Sponsor's protocol ID
- STU0020971
- Other IDs
- R01NS076589-01
- Status last verified
- May 2021
- First submitted
- 11 May 2015
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Neuroplasticity After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02446210
- Acronym / sponsor ID
- STU0020971
- Conditions
- Spinal Cord Injury
- Keywords
- SCI, Neural Control, Bilateral Movement, TMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 514 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 27 Jan 2022 (estimated)
- Study completion
- 27 Jan 2023 (estimated)
- First posted
- 18 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 long-term goal is to acquire scientific knowledge that can be used to develop mechanistic-driven intervention strategies aiming at restoring upper and lower-limb motor function in individuals with cervical or thoracic spinal cord injury (SCI). The proposed project will examine cortical, corticospinal, and spinal contribution to bilateral hand and arm muscle activity during bilateral movements and spinal contributions to lower limb muscle activity. By comparing changes in different sites within the Central Nervous System (CNS), the investigators may also identify key mechanisms that might be differentially affected by the injury, plasticity, and training.
Detailed description
If the participant qualifies to take part in this research study, they will be asked to participate in 15-190 study visits,to complete the experimental procedures. These procedures have been broken up into "Phases" and will be completed in any order. Phase I and Phase IIa includes 2-30 total visits - approximately 2-3 hours each to measure arm and finger strength and ability to move. Phase IIb includes 2-30 total visits - approximately 2-3 hours each, to measure leg strength and ability to move. Phase IIIa includes up to 40 total visits - approximately 2 hours each, the investigator will again evaluate the participant's ability to use both arms. The participant will be asked to complete a series of tasks such as stacking checkers, turning over cards, squeeze a device to determine how strong their grip is, and see how well they are able to feel sensations on the surface of their skin. The investigators will complete these assessments at pre-determined times during the study participation. Phase IIIb includes up to 40 total visits - approximately 2 hours each, the investigator will again evaluate the participant's ability to use both legs. Assessments of the participant's legs will include walking around the lab space, how well they can bend their ankles and hips, and how well they are able to feel sensations on the surface of the participant's skin.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls Group | Active comparator | Device: Magstim 200, Device: Digitimer electrical stimulatorMagstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation |
| Spinal Cord Injury Group | Active comparator | Device: Magstim 200, Device: Digitimer electrical stimulatorMagstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male and females between ages 18-85 years
- Right handed
- Able to complete precision grips with both hands
- Able to complete full elbow flexion-extension with both arms.
- Able to walk and complete lower-limb tests with both legs.
Key exclusion criteria (11 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 |
|---|---|---|
| Magstim 200Transcranial Magnetic Stimulation | Device | Healthy Controls Group, Spinal Cord Injury Group |
| Digitimer electrical stimulatorAlso: Electrical stimulationTranscranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation | Device | Healthy Controls Group, Spinal Cord Injury Group |
Primary outcome
Number of participants with reduced motor cortical excitability
Time frame: 5 months
Measured by Electroencephalogram/Electromyography and Electromyography/Electromyography coherence
2 secondary outcomes
Number of participants with enhance voluntary motor output in upper limbs
Time frame: 5 months
Number of participants with enhance voluntary motor output in lower limbs
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
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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, PhD, PT 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 Magstim 200 and Digitimer electrical stimulator 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 13 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 25 May 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica A Perez, PhD, PT (312-238-2886, mperez04@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with reduced motor cortical excitability (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 25 May 2021.