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RecruitingNCT07814313Updated Oct 14, 2026

Paired Stimulation Plasticity for Motor Recovery in Humans With and Without Spinal Cord Injury

A Phase 2 interventional study of CST PAS and RST PAS in Healthy Control and Spinal Cord Injury, sponsored by Shirley Ryan AbilityLab. Recruiting at 1 site in United States. Open to participants aged 19 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Shirley Ryan AbilityLab · Phase 2, Interventional, and Other

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Aug 2025, registered Sep 2026).
  • Started Aug 2025; still recruiting 1 year 2 months later.
Updated Oct 14, 2026Eligibility revisedInterventions changed+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
19 Years to 85 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Healthy Control
  • Spinal Cord Injury

Keywords

  • Spinal cord injury (SCI)
  • aging
  • motor control
  • motor recovery
  • plasticity
03

In context

Spinal Cord Injuries

2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.

This study's planned enrollment of 300 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Shirley Ryan AbilityLab is the lead sponsor of 180 studies on the registry; 44 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 4 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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;
  • 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;
  • 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.

Exclusion criteria for controls:

- Same as for subjects with SCI.

05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    CST PAS

    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

    Other: CST PAS

  • Active comparator
    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 in controls and humans with spinal cord injury

    Other: RST PAS

  • Sham comparator
    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. This will apply to controls and humans with spinal cord injury

    Other: sham PAS

Interventions

  • OtherCST PAS

    transcranial magnetic stimulation and peripheral nerve stimulation are given at almost the same time to target brain-to-spinal cord connections

  • OtherRST 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

  • Othersham 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Periprocedural

  2. 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.

    Time frame: Periprocedural

  3. 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

    Time frame: Periprocedural

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Eligibility
Revised
Oct 14, 2026
Interventions
Arms added: CST PAS·RST PAS·sham PAS; arms removed: healthy control·spinal cord injury
Oct 14, 2026
Design
Study type Observational→Interventional
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    Eligibility Revised
    Interventions Arms added: CST PAS·RST PAS·sham PAS; arms removed: healthy control·spinal cord injury
    Design Study type Observational→Interventional
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07814313
Responsible party
Monica Perez (Scientific Chair, Arms + Hands AbilityLab, Shirley Ryan AbilityLab) — Principal investigator
First posted
Sep 10, 2026
Start date
Aug 28, 2025
Primary completion
Sep 30, 2030 (estimated)
Completion
Sep 30, 2031 (estimated)
Last update
Oct 14, 2026

Study contacts

Monica Perez
Contact
mperez04@sralab.org
312-238-2886

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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