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Paired Stimulation Plasticity for Motor Recovery in Humans With and Without Spinal Cord Injury
9 september 2026 bijgewerkt door: Monica Perez, Shirley Ryan AbilityLab
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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Geschat)
300
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Monica Perez
- Telefoonnummer: 312-238-2886
- E-mail: mperez04@sralab.org
Studie Locaties
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Illinois
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Chicago, Illinois, Verenigde Staten, 60611
- Werving
- Shirley Ryan Abilitylab
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Contact:
- Monica Perez
- Telefoonnummer: 312-238-2886
- E-mail: mperez04@sralab.org
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Vulnerable populations, including children (<18 years) and pregnant women, will be excluded from this study.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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gezonde controle
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transcranial magnetic stimulation and peripheral nerve stimulation are given at almost the same time to target brain-to-spinal cord connections
transcranial magnetic stimulation and peripheral nerve stimulation are given at almost the same time to target brainstem-to-spinal cord connections
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
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spinal cord injury
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transcranial magnetic stimulation and peripheral nerve stimulation are given at almost the same time to target brain-to-spinal cord connections
transcranial magnetic stimulation and peripheral nerve stimulation are given at almost the same time to target brainstem-to-spinal cord connections
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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Motor evokoed potential
Tijdsspanne: 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
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Periprocedural
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MVC
Tijdsspanne: Periprocedural
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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.
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Periprocedural
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StartReact
Tijdsspanne: Periprocedural
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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
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Periprocedural
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
28 augustus 2025
Primaire voltooiing (Geschat)
30 september 2030
Studie voltooiing (Geschat)
30 september 2031
Studieregistratiedata
Eerst ingediend
1 september 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 september 2026
Eerst geplaatst (Werkelijk)
10 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 september 2026
Laatste update ingediend die voldeed aan QC-criteria
9 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STU00224061
- 1R01HD115345-01A1 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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