NCT07814313 · Shirley Ryan AbilityLab
Paired Stimulation Plasticity for Motor Recovery in Humans With and Without Spinal Cord Injury
What this study is about
This study will investigate how aging and spinal cord injury (SCI) affect the transmission and plasticity of the corticospinal and reticulospinal tracts, which are important pathways for motor control. The study includes two experiments. Experiment 1 will assess corticospinal and reticulospinal tract transmission to lower-limb muscles in older adults with and without SCI.
View original scientific description
This study will investigate how aging and spinal cord injury (SCI) affect the transmission and plasticity of the corticospinal and reticulospinal tracts, which are important pathways for motor control. The study includes two experiments. Experiment 1 will assess corticospinal and reticulospinal tract transmission to lower-limb muscles in older adults with and without SCI. Experiment 2 will examine how aging and spinal cord injury affect the body's ability to strengthen nerve pathways involved in movement. The investigators will compare two pathways that help control leg movement, the corticospinal and reticulospinal pathways, to determine whether aging affects these pathways differently and whether spinal cord injury has a greater effect on the corticospinal pathway.
Interventions
OTHER
CST PAS
transcranial magnetic stimulation and peripheral nerve stimulation are given at almost the same time to target brain-to-spinal cord connections
OTHER
RST PAS
electrical stimulation with a loud sound and peripheral nerve stimulation are given at almost the same time to target brainstem-to-spinal cord connections
OTHER
sham PAS
the setup will look and feel the same to the participant as the CST PAS or RST PAS. But one or both of the stimulations is not actually delivered, or it is delivered in a way that does not affect the participant
Primary outcome measures
Motor evokoed potential
Time frame: Periprocedural
Transcranial magnetic stimuli (TMS) will be delivered from a Magstim 200 stimulator (Magstim Company) through a double-cone coil with a monophasic current waveform. TMS will be delivered to the optimal scalp position for activation of upper or lower limb muscles. The optimal scalp position will be determined by moving the coil in small steps along the arm/leg muscle representation of the primary motor cortex to find the region where the largest MEP can be evoked with the minimum intensity in the targeted muscles. The muscles to be activated will be upper limb muscles such as deltoid, biceps, triceps, extensor carpi radialis, flexor carpi radialis and/or first dorsal interosseous; lower limb muscles such as quadriceps, hamstrings, tibialis anterior, soleus, and/or abductor hallucis muscles. Only the authorized research team will use the device and the investigator will comply with USFDA requirements for monitoring, records and reports. The research team will not market or promote the
MVC
Time frame: Periprocedural
Individuals will perform a maximum voluntary contraction (MVC) of the targeted muscles through surface electrodes secured to the skin over the belly of each muscle (Ag-AgCl, 10 mm diameter). The signals will be amplified, filtered (20-1000 Hz), and sampled at 10 kHz for offline analysis.
StartReact
Time frame: Periprocedural
The StartReact response will allow us make inferences about the contribution of the reticulospinal tract to spasticity. The StartReact response will be tested using a previously described paradigm in humans with and without SCI. Here, participants will be asked to observe a light-emitting diode (LED) located \~1 m in front of the participants' head. When the LED will illuminate (20 ms), individuals will be asked to perform an isometric elbow, knee and/or ankle flexion or an isometric elbow, knee and/or ankle extension as fast as possible. We will measure the visual reaction time (VRT) as the time from cue to onset of the EMG burst in the elbow muscles after the LED presentation. In some trials, the LED will be presented with either a quiet acoustic stimulus (80 dB, 500 Hz, 50 ms) or a startling acoustic stimulus (SAS, 120 dB, 500 Hz, 50 ms) delivered through a headphone. The time delay between the presentation of the quiet acoustic stimulus and the onset of the EMG response refer as th
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and females between 19-85 years;
- Chronic SCI (≥ 1 years post-injury);
- T10 or above - American Spinal Injury Association (AIS) Grade C, or D;
- Ability to perform a small voluntary ankle dorsiflexion, knee extension, and ankle plantarflexion (as detected by presence of voluntary EMG activity in the rectus femoris, tibialis anterior, and soleus muscles) with at least one leg;
- Ability to tolerate standing position;
- Ability to initiate at least one step without the assistance of a therapist;
- If ambulatory, ability to walk at a minimum speed of 0.1 m/s on a treadmill. Inclusion criteria for controls:
- Male and females (19-85 years);
- Able to perform dorsiflexion;
- Able to walk.
Exclusion criteria
- Uncontrolled medical problems including pulmonary, cardiovascular, or orthopedic disease;
- Any debilitating disease before 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;
- Ongoing cord compression or a syrinx in the spinal cord or spinal cord disease, such as spinal stenosis, spina bifida or herniated cervical disk;
- implanted defibrillators or implanted neurostimulators;
- have large ischaemic scars;
- diagnosed sleep deprivation. Exclusion criteria for controls: \- Same as for subjects with SCI.
Where
- Chicago, Illinois
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 14, 2026 · Source of record for eligibility and locations