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Thérapie de marche virtuelle pour la douleur neuropathique suite à une lésion incomplète de la moelle épinière

29 septembre 2026 mis à jour par: Texas A&M University

The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with incomplete spinal cord injury.

Aperçu de l'étude

Statut

Recrutement

Intervention / Traitement

Description détaillée

Many people with SCI experience neuropathic pain. Neuropathic pain is often described as sharp, burning, or electric. 'Traditional' treatments often do not do a good job of reducing neuropathic pain. Therefore, it is important to see if 'non-traditional' treatments might work. Scientists think that neuropathic pain occurs in SCI because the sensations coming from the eyes and up the spinal cord to the brain do not match what the brain thinks it told the body to do. This 'mismatch' may result in changes in the brain that make neuropathic pain possible. Virtual reality walking may potentially reduce this 'mismatch' by creating the 'illusion' that the person is walking. The brain then thinks it is telling the body to walk AND the information coming from the eyes matches its instructions. This 'matching' may reverse the brain changes that make neuropathic pain possible. The current study is specifically focused on individuals whose SCI has been classified as incomplete (ASIA B, C, or D).

Type d'étude

Interventionnel

Inscription (Estimé)

48

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.

Coordonnées de l'étude

  • Nom: Ami Lisenbee
  • Numéro de téléphone: 804-569-5965
  • E-mail: sci@vrwalk.org

Lieux d'étude

    • Texas
      • College Station, Texas, États-Unis, 77843
        • Recrutement
        • Texas A&M University
        • Chercheur principal:
          • Zina Trost, PhD
        • Contact:
          • Ami Lisenbee
          • Numéro de téléphone: 804-569-5965
          • E-mail: sci@vrwalk.org

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 et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

The study will recruit individuals with incomplete injury (American Spinal Injury Association [ASIA] classification B, C, or D) with lumbar, paraplegic, or low tetraplegic (C5-C7) injury. Additional criteria will include:

  1. Must have persistent NP symptoms that are of daily severity of at least 4/10 for 3 or more months
  2. Must endorse more than 2 items on a 7-item Spinal Cord Injury Pain Instrument, SCIPI
  3. Must be 18 years of age or older
  4. Must be more than one and a half years post-injury to begin study (can be screened at an earlier time for eligibility)
  5. Must have mobile connectivity with usable service
  6. Must be stable on pain medication for 1 or more months
  7. Must be cleared on the VRWalk physical activity clearance scale
  8. Must not have motion sickness that interferes with daily life
  9. Must use a wheelchair at least 75% of the time

Exclusion Criteria:

  1. Individuals with Injury levels between C1 and C4
  2. Individuals under the age of 18
  3. Individuals who were injured within the past year
  4. Individuals who cannot comprehend spoken English
  5. Individuals who are in prison
  6. Individuals who are blind
  7. Individuals who experience severe motion sickness

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: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Virtual reality (VR) game 1

Participants will be asked to play a virtual reality game twice a day for 10 days.

Individuals playing VR game 1 will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective.

Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart

Comparateur actif: Virtual reality (VR) game 2

Participants will be asked to play a virtual reality game twice a day for 10 days.

Individuals playing VR game 2 will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective.

Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Pain Intensity
Délai: Baseline - final follow up (up to 18 months)

The Numeric Rating Scale (NRS) measures pain intensity via a 0-10 numeric rating scale 0-10 where 0 is no pain, and 10 is the worst pain imaginable.

Baseline - final follow up (up to 18 months)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Pain Quality
Délai: Baseline - final follow up (up to 18 months)

The Neuropathic Pain Scale (NPS) assesses the distinct pain qualities, including sharpness, heat/cold, dullness, intensity, overall unpleasantness, and surface vs. deep pain. The NPS consists of 10 items. 0 equals 'No sensation' and 10 equals 'Worst sensation imaginable.' All the items are rated 0-10 scale, with a higher score indicative of more neuropathic pain for each type of respective pain.

Baseline - final follow up (up to 18 months)
Change in Pain Interference
Délai: Baseline - final follow up (up to 18 months)

The International Spinal Cord Injury Pain Basic Data Set version 2.0 interference assesses the degree to which pain interferes with day-to-day activities, mood, and sleep. Items are scored on a 0-10 numeric rating scale, and scores are summed to yield an interference score ranging from 0 to 30. Higher scores indicate greater interference from pain.

Baseline - final follow up (up to 18 months)
Post treatment change
Délai: at follow up (up to 18 months)

The Patient Global Impression of Change is a one item 7 point Likert item assessing improvement of the participants' overall status. A score of 1 is 'Very Much Improved', and a score of 7 is 'Very Much Worse.' Higher scores indicate less perceived improvement.

Range of scores: 1-7

at follow up (up to 18 months)
Change in mood
Délai: Baseline - final follow up (up to 18 months)

Mood will be assessed using the Patient Health Questionnaire-9. Participants will be asked to rate how often they have been bothered by specific problems on a 4-point Likert scale, where 0 is 'Not at all,' and 3 is 'Nearly every day.' The items are summed to yield a score ranging from 0-27. Higher scores indicate worse mood.

Baseline - final follow up (up to 18 months)
Change in quality of life
Délai: Baseline - final follow up (up to 18 months)

Quality of life is assessed by the Satisfaction with Life Scale. This is a 5 item survey. Response options are a 7-point Likert scale where 1 is 'Strongly disagree,' and 7 is 'Strongly agree'. Items may be assessed individually or by summing items.

Range of scores: 5-35. Higher scores indicate more satisfaction in life

Baseline - final follow up (up to 18 months)
Neurological changes
Délai: Baseline - 6 months

For eligible and interested participants, functional Magnetic Resonance Imaging (fMRI) will be used to observe neurological changes. Pre and post-study images will be compared by experienced researchers.

Baseline - 6 months

Collaborateurs et enquêteurs

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

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)

2 décembre 2024

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

1 octobre 2027

Dates d'inscription aux études

Première soumission

19 mars 2024

Première soumission répondant aux critères de contrôle qualité

19 mars 2024

Première publication (Réel)

26 mars 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

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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