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Spinal Stimulation + FES-Assisted Cough Training in SCI

1 juillet 2026 mis à jour par: Milap Sandhu

Combined Transcutaneous Spinal Stimulation + FES-Assisted Cough Training in Acute SCI

The overall objective of this proposal is to determine if transcutaneous spinal cord stimulation (tSCS) delivered concurrently with functional electrical stimulation (FES)-assisted cough training (FES-Cough) is an effective intervention to improve cough strength and coordination in individuals with acute/subacute SCI.

Aperçu de l'étude

Statut

Inscription sur invitation

Les conditions

Intervention / Traitement

Description détaillée

The overall objective of this proposal is to determine if transcutaneous spinal cord stimulation (tSCS) delivered concurrently with functional electrical stimulation (FES)-assisted cough training (FES-Cough) can synergistically improve cough strength and coordination in individuals with acute/subacute SCI. Aim 1: Determine the efficacy of tSCS combined with FES-Cough in individuals with acute/subacute SCI to improve cough strength and respiratory function. Spirometric values and respiratory pressures will be assessed as well as breathlessness and hypophonia after 20 sessions of active tSCS combined with FES-Cough vs. sham tSCS combined with FES-Cough administered over 4-6 weeks Aim 2: Analyze the effect of tSCS combined with FES-cough on cough coordination and sequencing through a detailed analysis of cough partial expiratory flow-volume (CPEFV) curves and respiratory muscle EMG before and after each of the interventions, including comparative analysis of EMG cough activity between individuals with neurologic injury and healthy control participants.

Th hypothesis is that participants receiving tSCS + FES-Cough will demonstrate significantly greater improvements in unstimulated peak cough flow, normalized cough phase timing, and improved flow-volume characteristics compared to the sham + FES-Cough group.

Type d'étude

Interventionnel

Inscription (Estimé)

60

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
    • Illinois
      • Chicago, Illinois, États-Unis, 60611
        • Shirley Ryan Abilitylab

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

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

Inclusion Criteria:

  • Currently admitted for inpatient rehabilitation at Shirley Ryan AbilityLab
  • History of traumatic spinal cord injury with Neurologic Level of Injury (NLI) C1-T1, and AIS A-C on admission exam
  • Between 14-60 days from date of injury at time of enrollment
  • Baseline PCF below 270 L/min
  • Anatomical airway or tolerating occlusion of tracheostomy with either a one-way speaking valve or a cap for at least 60 minutes
  • Medically cleared by the participants primary inpatient physiatry attending physician

Exclusion Criteria:

  • Individuals with pre-morbid chronic pulmonary conditions, day-time ventilator dependence, uncontrolled autonomic dysreflexia, moderate to severe traumatic brain injury, developmental delay, diagnosis of active cancer, or secondary progressive neurologic disorder

  • Individuals with contraindications to the interventions of interest:

    1. TSCS and Abdominal FES: pacemaker, compromised skin integrity under site of stimulation, implanted defibrillators, deep brain stimulator(s), uncontrolled epilepsy or seizures, pregnancy, recent myocardial infarct, diaphragmatic pacer
    2. TSCS: Severe osteoporosis
    3. Abdominal FES: unhealed rib fracture, sternal precautions, recent pneumothorax, spine bracing impacting ability to place stimulation pads.
  • Individuals with medical instability impacting the safety and feasibility of participation including the inability to tolerate sitting upright >45 degrees for 15 minutes, acute unresolved medical complications as determined by study physician to be exclusionary, transferred to higher level of medical care for ≥5 consecutive days or >14 days total during trial period, and those with halo spine bracing
  • Individuals who are currently enrolled in another interventional research study are excluded from participating to eliminate potential influence of additional experimental interventions on study outcomes and to maintain standardization of study protocol

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: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur factice: Sham tSCS + FES-Assisted Cough
In this group, the tSCS spinal stimulation will be sham, providing no additional electrical input, while the FES assisted cough intervention will remain
Autre: Sham tSCS + FES assisted cough
A clinician will don the electrodes on the participant for 20, 30 minute sessions 2 to 4 times per week for 4 to 6 weeks. tSCS will utilize multi-site stimulation at C3-C4 and T9-10, with simulation intensity being set for each electrode which produces a visible muscle twitch. The sham group will have intensity will be ramped up to sensation for 1 minute then ramped down and turned off FES will be set up by placing electode pads in the posterolateral positon on the trunk. Baseline stimulation parameters are 50Hz Frequency, 250-400μs pulse duration, altering monophasic waveform, amplitude dependent on participant response.
Comparateur actif: tSCS + FES-Assisted Cough
This group will receive the combination of tSCS spinal stimulation and FES assisted cough simultaneously
Autre: tSCS combined with FES-Cough

A clinician will don the electrodes on the participant for 20, 30 minute sessions 2 to 4 times per week for 4 to 6 weeks.

tSCS will utilize multi-site stimulation at C3-C4 and T9-10, with simulation intensity being set for each electrode which produces a visible muscle twitch.

FES will be set up by placing electode pads in the posterolateral positon on the trunk. Baseline stimulation parameters are 50Hz Frequency, 250-400μs pulse duration, altering monophasic waveform, amplitude dependent on participant response.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Peak Cough Flow
Délai: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Assesses functional cough strength via a digital peak flow by asking the participant to cough three times into the device. The maximum number will be recorded.
From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Cough Partial Expiratory Flow Volume
Délai: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Assesses the effectiveness of a cough by plotting airflow during the cough against lung volume, and allowing all phases of cough to be visualized and calculate spirometric measurements. The participant will be fit with a facemask that will go over their nose and mouth, and then be asked to perform a series of single coughs and sequential coughs.
From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Maximum inspiratory pressure
Délai: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Assesses respiratory muscle strength by asking the participants to inhale or exhale quickly with their lips sealed around the mouthpiece of the training device to find maximum inspiratory pressure (MIP)
From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Changes in electromyography (EMG) of respiratory muscles
Délai: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Assesses respiratory muscle activation during the cough. We will use surface EMG electrodes placed on various respiratory muscles on the abdomen and upper trunk to plot muscle activation during single and sequential cough epochs.
From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Maximum expiratory pressure
Délai: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Assesses respiratory muscle strength by asking the participants to inhale or exhale quickly with their lips sealed around the mouthpiece of the training device to find maximum expiratory pressure (MEP)
From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Forced expiratory volume
Délai: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Assesses respiratory muscle strength by asking the participants to inhale or exhale quickly with their lips sealed around the mouthpiece of the training device to find forced expiratory volume in the first second (FEV1)
From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks

Collaborateurs et enquêteurs

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

Parrainer

Milap Sandhu

Collaborateurs

Shirley Ryan AbilityLab

Les enquêteurs

  • Chercheur principal: Milap Sandhu, PhD, PT, Shirley Ryan Abilitylab

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 (Estimé)

15 juin 2026

Achèvement primaire (Estimé)

1 juin 2029

Achèvement de l'étude (Estimé)

1 janvier 2030

Dates d'inscription aux études

Première soumission

12 juin 2026

Première soumission répondant aux critères de contrôle qualité

1 juillet 2026

Première publication (Réel)

6 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juillet 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • STU00225588
  • 1529723 (Autre subvention/numéro de financement: Craig H. Neilsen Foundation)

Plan pour les données individuelles des participants (IPD)

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

OUI

Description du régime IPD

Upon request, de-identified data may be shared by the principal investigator

Délai de partage IPD

Until 3 years following conclusion of study procedures

Critères d'accès au partage IPD

Principal investigator will retain this access and distribute upon request

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF

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

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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