Healthy ControlPhase 2NCT07814313
Paired Stimulation Plasticity for Motor Recovery in Humans With and Without Spinal Cord Injury
A Phase 2 study testing CST PAS and RST PAS in people with Healthy Control and Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Control, Spinal Cord Injury
- What is being tested?
- CST PAS and RST PAS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2025to 30 Sep 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 19 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
- Pacemaker;
- Metal plate in skull;
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- 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;
- Pregnancy;
- 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.
- Same as for subjects with SCI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan Abilitylab
Chicago, Illinois, 60611
Monica Perez, 312-238-2886, mperez04@sralab.org
About this study
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.
- Conditions
- Healthy Control, Spinal Cord Injury
- Being tested
- CST PAS, RST PAS, sham PAS
- Keywords
- Spinal cord injury (SCI), aging, motor control, motor recovery, plasticity
- 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.
CST PASOther
transcranial magnetic stimulation and peripheral nerve stimulation are given at almost the same time to target brain-to-spinal cord connections
RST PASOther
electrical stimulation with a loud sound and peripheral nerve stimulation are given at almost the same time to target brainstem-to-spinal cord connections
sham PASOther
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
| Study group | Role | What they receive |
|---|---|---|
| CST PAS | Active comparator | Transcranial magnetic stimulation and peripheral nerve stimulation are given at almost the same time to target brain-to-spinal cord connections in controls and humans with spinal cord injury Receives: Other: CST PAS |
| RST PAS | Active comparator | Electrical stimulation with a loud sound and peripheral nerve stimulation are given at almost the same time to target brainstem-to-spinal cord connections in controls and humans with spinal cord injury Receives: Other: RST PAS |
| sham PAS | Sham comparator | 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. This will apply to controls and humans with spinal cord injury Receives: Other: sham PAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evokoed potential
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
Measured: Periprocedural
MVC
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.
Measured: Periprocedural
StartReact
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
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start28 Aug 2025
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ControlStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Monica Perez, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814313
- Sponsor's protocol ID
- STU00224061
- Other IDs
- 1R01HD115345-01A1
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired Stimulation Plasticity for Motor Recovery in Humans With and Without Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07814313
- Acronym / sponsor ID
- STU00224061
- Conditions
- Healthy Control, Spinal Cord Injury
- Keywords
- Spinal cord injury (SCI), aging, motor control, motor recovery, plasticity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 10 Sep 2026 (actual)
- 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CST PAS | Active comparator | Other: CST PASTranscranial magnetic stimulation and peripheral nerve stimulation are given at almost the same time to target brain-to-spinal cord connections in controls and humans with spinal cord injury |
| RST PAS | Active comparator | Other: RST PASElectrical stimulation with a loud sound and peripheral nerve stimulation are given at almost the same time to target brainstem-to-spinal cord connections in controls and humans with spinal cord injury |
| sham PAS | Sham comparator | Other: sham PASThe 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. This will apply to controls and humans with spinal cord injury |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
- Pacemaker;
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 |
|---|---|---|
| CST PAStranscranial magnetic stimulation and peripheral nerve stimulation are given at almost the same time to target brain-to-spinal cord connections | Other | CST PAS |
| RST PASelectrical stimulation with a loud sound and peripheral nerve stimulation are given at almost the same time to target brainstem-to-spinal cord connections | Other | RST PAS |
| sham PASthe 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 | Other | sham PAS |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CST PAS and RST PAS in people with Healthy Control and 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 10 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 14 Oct 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Perez (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?
Motor evokoed potential (time frame: Periprocedural). The study lists 3 primary outcomes in all. 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 14 Oct 2026.