- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07814313
Paired Stimulation Plasticity for Motor Recovery in Humans With and Without Spinal Cord Injury
9. September 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
300
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Monica Perez
- Telefonnummer: 312-238-2886
- E-Mail: mperez04@sralab.org
Studienorte
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60611
- Rekrutierung
- Shirley Ryan Abilitylab
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Kontakt:
- Monica Perez
- Telefonnummer: 312-238-2886
- E-Mail: mperez04@sralab.org
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
Vulnerable populations, including children (<18 years) and pregnant women, will be excluded from this study.
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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gesunde Kontrolle
|
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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Motor evokoed potential
Zeitfenster: Periprocedural
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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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
28. August 2025
Primärer Abschluss (Geschätzt)
30. September 2030
Studienabschluss (Geschätzt)
30. September 2031
Studienanmeldedaten
Zuerst eingereicht
1. September 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. September 2026
Zuerst gepostet (Tatsächlich)
10. September 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
10. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. September 2026
Zuletzt verifiziert
1. September 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STU00224061
- 1R01HD115345-01A1 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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