- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02446210
Neuroplasticity After Spinal Cord Injury
May 21, 2021 updated by: Monica Perez, Shirley Ryan AbilityLab
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
514
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Shirley Ryan AbilityLab
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Inclusion criteria for individuals with SCI:
- 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.
- 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
Inclusion criteria for healthy controls:
- 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.
Exclusion Criteria:
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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Healthy Controls Group
Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation
|
Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation
Other Names:
|
ACTIVE_COMPARATOR: Spinal Cord Injury Group
Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation
|
Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with reduced motor cortical excitability
Time Frame: 5 months
|
Measured by Electroencephalogram/Electromyography and Electromyography/Electromyography coherence
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with enhance voluntary motor output in upper limbs
Time Frame: 5 months
|
Measured by spike-timing-dependent plasticity
|
5 months
|
Number of participants with enhance voluntary motor output in lower limbs
Time Frame: 5 months
|
Measured by spike-timing-dependent plasticity
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Monica A Perez, PhD, PT, Shirley Ryan AbilityLab
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 28, 2021
Primary Completion (ANTICIPATED)
January 27, 2022
Study Completion (ANTICIPATED)
January 27, 2023
Study Registration Dates
First Submitted
May 11, 2015
First Submitted That Met QC Criteria
May 15, 2015
First Posted (ESTIMATE)
May 18, 2015
Study Record Updates
Last Update Posted (ACTUAL)
May 25, 2021
Last Update Submitted That Met QC Criteria
May 21, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU0020971
- R01NS076589-01 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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