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Thérapie de marche par stimulation vertébrale contrôlée par le cerveau après une lésion incomplète de la moelle épinière (LME)

29 septembre 2026 mis à jour par: Matija Milosevic, University of Miami

Thérapie de stimulation vertébrale contrôlée par le cerveau pour la restauration de la marche après une lésion incomplète de la moelle épinière (LME)

The purpose of this research is to test the effectiveness of a new therapy, called Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS), for improving walking in people with an incomplete spinal cord injury (SCI).

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

6

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Florida
      • Miami, Florida, États-Unis, 33136
        • University of Miami

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. At least 18 years old and no older than 70 years old at the time of enrollment.
  2. Traumatic incomplete spinal cord injury (neurological level at or above T10 spinal cord level; Abbreviated Injury Scale (AIS) C or D impairment grade for group 1, 3 and 4 and AIS B, C or D impairment grade for group 2), who are more than 6 months post-injury.
  3. Has detectable motor function in at least 2 muscles per side confirmed by voluntary Electromyography (EMG) or detectable tibialis anterior (TA) muscle motor evoked potentials (MEPs) at the baseline assessment.
  4. Able to commit to intensive training and assessment sessions over a maximum total duration of 12 months (6 months of treatment).
  5. Could effectively walk overground for at least 10 meters with some assistance of a therapist and minimal body-weight support, with functional spasticity (by participant's self-report), functional range-of-motion of lower limb joints, and acceptable bone mass to enable body-weight support, confirmed by Dual-energy X-ray absorptiometry (DXA) scan.

Exclusion Criteria:

  1. Has traumatic brain injury, stroke, multiple sclerosis, or other neuromuscular disorders that could affect neuromotor function and walking.
  2. Has severe spasticity that could prevent stepping and walking function determined by the investigator.
  3. Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
  4. Has other contra-indications for transcranial magnetic stimulation (TMS) or Transcutaneous Spinal Cord Stimulation (TSCS).
  5. Has a history of recent seizures or poorly managed autonomic dysreflexia that could be triggered by TMS or TSCS.
  6. Has a history of prior intracranial surgery or known lesions that would limit TMS assessments and Brain-Computer Interface (BCI) recordings.
  7. Individuals with metal implants in their head and other implantable devices in the body that could be affected by TMS or TSCS.
  8. Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.).
  9. Has urinary tract infection, unhealed fracture, contracture, and pressure sore (Braden Scale).
  10. Has breakdown in skin area that will come into contact with electrodes.
  11. Individuals who require therapy or other care that could interfere with participation in the study.
  12. Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function.
  13. Individuals with substance disorders, including alcoholism and drug abuse.
  14. Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study.
  15. In the opinion of the investigators, the study is not safe or appropriate for the participant.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS)

Participants will receive brain-computer interface (BCI)-triggered transcutaneous spinal cord stimulation (tSCS) combined with activity-based training 3 to 4 times per week. The BCI system detects movement attempts and triggers stimulation delivered through the Neostim 5 spinal cord stimulator. Participants will participate in the therapy for up to 12 months.
Dispositif: Brain-Computer Interface-Triggered Transcutaneous Spinal Cord Stimulation (BCI-tSCS) System

Participants will receive brain-computer interface (BCI)-triggered transcutaneous spinal cord stimulation (tSCS) using the Neostim 5 spinal cord stimulator during activity-based training sessions. The BCI system detects movement attempts and triggers delivery of transcutaneous spinal cord stimulation. Intervention sessions will occur 3 to 4 times per week throughout the study intervention period.

Autres noms:
  • Neostim 5 Spinal Cord Stimulator

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of related neurological deterioration (LEMS)
Délai: up to 12 months

Lower Extremity Motor Score (LEMS) to assess lower limb muscle function following the American Spinal Injury Association Impairment Scale (ASIA) guidelines. The LEMS evaluates motor function on a scale of 0 (no motor function) to 5 (full motor function).
up to 12 months
Number of treatment related incidence of adverse events (AEs)
Délai: up to 12 months

Safety will be reported as the incidence of treatment related AEs as assessed by the study doctor
up to 12 months
Number of subjects that complete the study
Délai: up to 12 months

Safety will be determined by number of subjects that complete the study, as designed.
up to 12 months
Walking function using 10 meter walk test (10MWT)
Délai: up to 12 months

This is a test of short-distance walking function. The subject will be asked to walk at a comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway. Time is measured in meters per seconds.
up to 12 months
Walking function using 6 minute walk test (6MWT)
Délai: up to 12 months

The object of the test is to walk as far as possible for 6 minutes. The subject will walk at a normal pace around a marked course for 6 minutes. The subject may stop to rest and begin again at will. The distance covered indicates aerobic fitness. The further a subject walks, the better their cardiovascular condition. Units are measured in meters.
up to 12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Mobility measured by Timed Up and Go (TUG) Test
Délai: up to 12 months.

The Timed Up and Go test or TUG test is used to help evaluate mobility. It measures, in seconds, how long it takes subjects to stand up, walk 10 feet, turn around, walk back, and sit down.
up to 12 months.
Balance measured by the Berg Balance Scale (BBS)
Délai: up to 12 months.

BBS is an assessment to determine balance. The BBS consists of 14 items scored on a 5-point ordinal scale, ranging from 0 to 4 (0 indicates lowest level of function; 4 indicates highest level of function), with a maximum total score of 56.
up to 12 months.
Muscular spasticity measured by the Modified Ashworth Scale (MAS)
Délai: up to 12 months.

The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity.
up to 12 months.
Muscular spasticity measured by the Pendulum Test
Délai: up to 12 months.

The Pendulum Test will be used to measure muscular spasticity. During the pendulum test, the participant will be lying on a therapy mat with the lower leg hanging off the edge of the mat. A member of the study staff will support the participant's extended lower leg and then release the leg allowing it to swing freely. This test will be video recorded and the movement of the knee joint will be measured using software on the computer. Muscular spasticity will be calculated by the number of the Relaxation index (R1 and R2) and compared to norms.
up to 12 months.
Walking assistance measured by the Walking Index for Spinal Cord Injury Scale (WISCI II)
Délai: up to 12 months

WISCI II is an ordinal scale using a rank ordering along a dimension of impairment, from the level of most severe impairment (0) to least severe impairment (20) based on the use of devices, braces and physical assistance of one or more persons. The order of the levels suggests each successive level is a less impaired level than the former.
up to 12 months
Independence as measured by Spinal Cord Independence Measure (SCIM III)
Délai: up to 12 months

SCIM III assesses performance in activities of daily living Scores range from 0-100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence.
up to 12 months
Quality of Life using the International Spinal Cord Injury - Quality of Life (ISCI-QOL)
Délai: up to 12 months

ISCI-QOL consists of three single items on satisfaction with life as a whole, physical health and psychological health using a 0-10 scale where 0=complete dissatisfaction; 10=complete satisfaction.
up to 12 months
Quality of Life measured by the Reintegration to Normal Living (RNL) questionnaires
Délai: up to 12 months

RNL is a self-report questionnaire that assesses a person's satisfaction with performance in life activities. The RNL index assesses mobility, self-care, daily activity, recreational activity, and family roles.

The RNL includes 11 declarative statements and a composite score will be calculated. Minimum Score = 0; Maximum Score = 100. Higher scores indicate greater reintegration.
up to 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Miami

Collaborateurs

United States Department of Defense

Les enquêteurs

  • Chercheur principal: Matija Milosevic, PhD, University of Miami - MSOM

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

7 mai 2024

Achèvement primaire (Estimé)

31 décembre 2026

Achèvement de l'étude (Estimé)

31 décembre 2026

Dates d'inscription aux études

Première soumission

6 mai 2024

Première soumission répondant aux critères de contrôle qualité

6 mai 2024

Première publication (Réel)

9 mai 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 septembre 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 20240091

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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