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El ensayo clínico NCT07223710 para Lesión de la médula espinal está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Improving Walking After Spinal Cord Injury
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El ensayo clínico NCT07223710 está diseñado para estudiar el tratamiento de Lesión de la médula espinal. Este es un estudio intervencionista de Fase I Fase II. Su estado actual es: aún no recluta. Se planea que el reclutamiento se inicie el 15 de noviembre de 2025 hasta que el ensayo reclute a 20 participantes. Dirigido por Shirley Ryan AbilityLab, se espera que finalice el 30 de julio de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 3 de noviembre de 2025.
Resumen
Locomotor recovery is one of the most important goals of individuals with spinal cord injury (SCI). Ambulatory deficits severely impact daily functions resulting in lower quality of life for people living with paralysis due to SCI. Although studies have shown that locomotor training improves locomotor function in people with chronic SCI, the benefits remain limited. Our overall hypothesis is that we can engage additional descending motor pathways, such as the reticulospinal tract (RST), to improve locomotor function in humans with chronic incomplete SCI.
In this study we propose to test the effects of a novel intervention that uses repeated paired loud auditory and electrical stimulation of muscle afferents combined with locomotor training on walking speed and voluntary muscle strength.
Descripción detallada
Individuals with chronic incomplete SCI will be randomly assigned to a group that will receive 10 sessions of a startle stimulus (a very brief, loud sound) and electrical stimulation combined with locomotor training or 10 sessions of a non-startle stimulus (a very brief, soft sound) combined with locomotor training.
Título oficial
Engaging Reticulospinal Inputs to Improve Walking Ability in Humans With Spinal Cord Injury
Condiciones médicas
Lesión de la médula espinalOtros ID del ensayo
Número del NCT
Inicio del ensayo (real)
2025-11-15
Última actualización
2025-11-03
Fecha de finalización (estimada)
2026-07-30
Inscripción (prevista)
20
Tipo de estudio
Intervencionista
FASE
Fase I
Fase II
Fase II
Estado general
Aún no recluta
Palabras clave
auditory stimulation
peripheral stimulation
locomotion training
descending motor tracts
peripheral stimulation
locomotion training
descending motor tracts
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Simple
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalLocomotor training + PAS This intervention uses repeated paired loud auditory and electrical stimulation of muscle afferents combined with locomotor training.
Participants will exercise walking on a treadmill with body weight support as needed for 30 minutes a day at a moderate intensity. While walking, participants will receive brief loud auditory stimuli through headphones and short electrical pulses through of electrodes positioned on two points in the leg | Paired Associative Stimulation This new intervention consists of locomotor training in combination with paired low-intensity electrical stimulation and stimulation of the reticulospinal tract through loud sounds. Participants will receive auditory stimulation (LAS, 110dB, 500Hz, 50ms) through headphones and electrical stimulation through a pair of electrodes with 2cm inter-electrode distance positioned on the motor point over the quadriceps and the tibialis anterior muscles bilaterally. The motor point will be identified as the position of the electrodes that elicits a small visible muscle twitch or muscle contraction upon palpation over the tendon with the minimum stimulation intensity. Stimuli will be delivered with a pulse duration of 200 microseconds and will be timed to arrive at the level of the brainstem \~7ms before auditory signals. Entrenamiento locomotor Participants will walk on a treadmill with body-weight support (ZeroG, Aretech) in the range 0-70% as needed to prevent excessive knee flexion during stance phase or toe dragging during swing phase (Finch et al. 1991). Each session will last approximately 60-min and the duration of the treadmill training will be timed to be 30 min. Subjects will be encouraged to walk at a self-selected speed at or above 0.1m/s. Speed and body-weight support will be adjusted to achieve a perceived exertion score of 4-5 (Moderate) in the Borg scale (Borg 1982). Subjects will be allowed to rest as needed during the training sessions. |
Comparador simuladoLocomotor training + SHAM This sham intervention uses repeated paired soft auditory clicks and electrical stimulation of muscle afferents combined with locomotor training.
Participants will exercise walking on a treadmill with body weight support as needed for 30 minutes a day at a moderate intensity. While walking, participants will receive brief auditory clicks through headphones and short electrical pulses through a pair of electrodes positioned on two points in the leg. | Entrenamiento locomotor Participants will walk on a treadmill with body-weight support (ZeroG, Aretech) in the range 0-70% as needed to prevent excessive knee flexion during stance phase or toe dragging during swing phase (Finch et al. 1991). Each session will last approximately 60-min and the duration of the treadmill training will be timed to be 30 min. Subjects will be encouraged to walk at a self-selected speed at or above 0.1m/s. Speed and body-weight support will be adjusted to achieve a perceived exertion score of 4-5 (Moderate) in the Borg scale (Borg 1982). Subjects will be allowed to rest as needed during the training sessions. Estimulación simulada Participants will receive brief low-intensity auditory clicks (80dB, 500Hz, 50ms) through headphones and electrical stimulation through a pair of electrodes with 2cm inter-electrode distance positioned on the motor point over the quadriceps and the tibialis anterior muscles bilaterally. The motor point will be identified as the position of the electrodes that elicits a small visible muscle twitch or muscle contraction upon palpation over the tendon with the minimum stimulation intensity. Stimuli will be delivered with a pulse duration of 200 microseconds and will be timed to arrive at the level of the brainstem \~7ms before auditory signals. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
10-meter walk test (10MWT) | This standardized test assesses walking speed in meters per second over a short duration. | baseline and day 12 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Motor Evoked Potentials conditioned with Startle (MEP-LAS) | Motor Evoked Potentials (MEPs) will be recorded from multiple leg muscles following transcranial magnetic stimulation over the leg representation of the primary motor cortex and electrical stimulation over the thoracic spine. Loud auditory Stimuli (LAS, 110dB, 500Hz, 50ms) will be delivered 50ms before magnetic stimulation to test for cortical effects of the intervention and 80ms before the electrical stimulation to test for subcortical effects of the intervention. Stimulation intensity will be adjusted to obtain unconditioned MEPs of \~50% of the maximum MEP for each muscle. | Baseline and day 12 |
Maximum Voluntary Contraction (MVC) | This will be measured on the electromyographic signal recorded during maximal isometric contractions. Participants will perform three maximal contractions against resistance into knee flexion and extension, dorsiflexion, and plantarflexion. Electromyographic activity will be monitored using surface electrodes placed on the belly of the quadriceps femoris, hamstrings, tibialis anterior, and soleus muscles bilaterally. The MVC will be quantified as the maximum value of the average over 1s of activity in each of the repetitions. | Baseline and day 12 |
Maximal motor response (M-max) | M-max will be elicited in the quadriceps femoris, tibialis anterior, soleus and foot muscles by applying percutaneous electrical stimulation over the femoral, common peroneal and the tibial and the medial plantar nerve, respectively using 200μs rectangular electrical stimulus. The intensity of stimulation will be increased progressively until M-max is reached. | Baseline and day 12 |
StartReact response | Participants will be asked to observe a light-emitting diode (LED) located \~1 m in front of the participants' head and will be wearing headphones. When the LED will illuminate (20 ms), individuals will be asked to perform an isometric knee flexion/extension and/or ankle dorsi/plantarflexion as fast as possible. Reaction times will be evaluated following a visual cue either alone (20 trials) or paired with a non-startling (80dB, 500Hz, 50ms, 20 trials) or a startling (110dB, 500Hz, 50ms, 20 trials) auditory cue. Stimuli will be delivered every 5s in a randomized order. Target muscles will be quadriceps femoris, hamstrings, tibialis anterior, and soleus muscles of the weaker leg. The StartReact response will be computed as the difference between the reaction times during a non-startling and startling auditory cue | Baseline and day 12 |
Spasticity | We will use the Modified Ashworth scale (six-point ordinal scale, 0-4) to measure resistance encountered during manual passive muscle stretching. | Baseline and day 12 |
SCI-QOL | Is a battery of questionnaires evaluating the quality of life. Will be used to measure the participant-related following aspects: (a) Ambulation: This questionnaire will ask the participant about their ability to do thing like walk, run and jump. (b) Basic Mobility: This questionnaire will ask the participant about their ability to perform their daily routine. (c) Fine Motor: This questionnaire will ask the participant about their ability to pick up small objects. (d) Manual and Power Wheelchair Mobility: This questionnaire ask the participant about their ability using a wheelchair. (e) Self-Care: This questionnaire will ask the participant about their ability to do activities of daily living such as getting dressed, bathing, and eating. | Baseline and day 12 |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- History of traumatic or non-traumatic SCI ≥ 6 months
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) level at and above T10.
- American Spinal Injury Association AIS Grade C, or D
- Weakness in ankle dorsiflexors (LEMS<=3) with the ability to perform a small voluntary ankle dorsiflexion (as detected by presence of voluntary EMG activity in the tibialis anterior) with at least one leg.
- Ability to tolerate standing position.
- Ability to walk at a minimum speed of 0.1 mile/hour on a treadmill with less than 70% body weight support.
- Requires use of assistive devices (KAFO, AFO, cane, walker) or body weight support for ambulation.
- Ability to complete the 10-Meter Walk Test.
- Preceding uncontrolled medical conditions including pulmonary, cardiovascular or orthopedic disease that interfere with physical performance.
- Intolerance to physical activity.
- Severe cognitive impairment that precludes the ability to participate in any of the study procedures or give verbal consent.
- Any illness or condition that based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during the study.
- History of stroke resulting in sensory motor deficits.
- Pregnant women.
- Participation in a high-intensity locomotor training program in the last 6 months.
- Inability to detect somatosensory evoked potentials
- Metal implant in the head
- History of epilepsy
Shirley Ryan AbilityLabEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Parte responsable del ensayo
Dalia DeSantis, Investigador principal, Research Scientist, Shirley Ryan AbilityLab
Contactos centrales del ensayo
Contacto: Dalia De Santis, 312-238-7895, [email protected]
1 Sitios del ensayo en 1 países
Illinois
Shirley Ryan AbilityLab, Chicago, Illinois, 60611, United States
Dalia De Santis, Contacto, 312-238-7895, [email protected]
Dalia De Santis, PhD, Investigador principal
Monica Perez, PT, PhD, Subinvestigador