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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07814313
Enrollment
300
Registered
2026-09-10
Start date
2025-08-28
Completion date
2031-09-30
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Control, Spinal Cord Injury

Keywords

Spinal cord injury (SCI), aging, motor control, motor recovery, plasticity

Brief 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.

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

transcranial magnetic stimulation 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

Sponsors

Shirley Ryan AbilityLab
Lead SponsorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Motor evokoed potentialPeriproceduralTranscranial 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
MVCPeriproceduralIndividuals 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.
StartReactPeriproceduralThe 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

Countries

United States

Contacts

CONTACTMonica Perez
mperez04@sralab.org312-238-2886

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026