Paired VNS For TBI Rehabilitation (VNS for TBI)
This study is evaluating whether pairing vagus nerve stimulation (VNS) with structured upper limb rehabilitation therapy can improve arm and hand function in individuals with moderate to severe traumatic brain injury (TBI).
Many people who survive a TBI experience long-term weakness, poor coordination, and difficulty using one arm or hand. These motor impairments can significantly affect independence and quality of life. Traditional rehabilitation can help, but recovery is often incomplete.
Vagus nerve stimulation (VNS) is an FDA-approved therapy for certain neurological conditions and involves a small device implanted under the skin in the chest with a lead connected to the vagus nerve in the neck. The device delivers mild electrical pulses to the nerve. In this study, VNS will be paired with goal-directed upper limb rehabilitation exercises. The stimulation is delivered during specific movements in therapy sessions. This "paired stimulation" approach is designed to enhance neuroplasticity - the brain's ability to reorganize and form new connections - which may improve motor recovery.
The VNS device used in this study is FDA-approved for other conditions. However, its use paired with rehabilitation for upper limb recovery after traumatic brain injury is investigational.
Participants in this study will:
Undergo surgical implantation of the VNS device.
Participate in structured upper limb rehabilitation therapy sessions where stimulation is paired with specific movements.
Complete follow-up visits and assessments to measure changes in arm and hand function, strength, dexterity, and overall recovery.
The main goal of the study is to determine whether paired VNS and rehabilitation improves upper limb motor function compared to rehabilitation alone. Safety will also be closely monitored, including surgical outcomes and any device-related effects.
This study may help determine whether VNS paired with rehabilitation is a safe and effective way to enhance motor recovery after traumatic brain injury. Findings from this research could contribute to improved treatment strategies for individuals living with long-term motor impairments following TBI.
Participation is voluntary. All participants will be carefully evaluated to determine eligibility, and informed consent will be obtained before enrollment.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sima Mofakham, PhD
- Numéro de téléphone: 631-444-1278
- E-mail: sima.mofakham@stonybrookmedicine.edu
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age 22-80 years
- History of severe TBI (initial GCS ≤ 8)
- Regained consciousness with capacity to consent to the study
- At least six months since injury
- Full recovery of consciousness with command following (mGCS = 6)
- Ongoing motor impairment with dependence in activities of daily living (modified Rankin Scale, mRS = 3-4)
- Clinically stable for VNS implantation
Exclusion Criteria:
- No capacity to consent to the study
- History of stroke
- History of cognitive disorder or other neurodegenerative disorder
- History of epilepsy treated by VNS
- History of brain tumors (primary or metastatic)
- Requires diathermy
- Pregnant
- Previously implanted vagus nerve stimulator
- Extensive prior neck surgery preventing dissection of the vagus nerve
- History of severe spasticity, vagus nerve damage, or hearing loss
Plan d'étude
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: VNS Group
Group to be implanted with VNS devices
|
Group will be implanted with VNS device for chronic TBI
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With Device- or Procedure-Related Adverse Events
Délai: 6 Weeks
|
Adverse events related to VNS device implantation or stimulation will be recorded and graded using CTCAE v5.0.
|
6 Weeks
|
|
Change in Upper Limb Range of Motion as Assessed by SeeMe Movement Analysis
Délai: 6 Weeks
|
Video-based kinematic analysis of upper limb range of motion, comparing baseline (pre-surgery) to post-training (6 weeks after VNS-paired rehabilitation).
|
6 Weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Disability Rating Scale (DRS) Score
Délai: 1 Year
|
RS score (range 0 [no disability] to 29 [extreme vegetative state]; lower scores indicate better outcome).
Magnitude of change will be used to estimate effect size for power calculation in a future multicenter randomized trial.
|
1 Year
|
|
Change in Coma Recovery Scale-Revised (CRS-R) Score
Délai: 6 Weeks
|
CRS-R total score (range 0-23; higher scores indicate better neurobehavioral function), comparing baseline to post-training.
|
6 Weeks
|
|
Change in Wolf Motor Function Test (WMFT) Performance Time
Délai: 6 Weeks
|
Time (seconds) to complete standardized WMFT tasks; lower time indicates better function.
Comparing baseline to post-training.
|
6 Weeks
|
|
Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) Score
Délai: 6 Weeks
|
FMA-UE score (range 0-66; higher scores indicate better motor function), comparing baseline to post-training.
|
6 Weeks
|
|
Change in Motor Activity Log (MAL) Score
Délai: 1 Year
|
MAL Amount of Use and Quality of Movement subscales (range 0-5 each; higher scores indicate better real-world arm use).
|
1 Year
|
|
Change in EQ-5D-5L Index Score
Délai: 1 Year
|
EQ-5D-5L index score (range 0 [death] to 1 [full health]; higher scores indicate better quality of life).
|
1 Year
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Q251552
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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 .
Essais cliniques sur TBI (Traumatisme Cérébral)
-
Kessler FoundationInstituto Vocacional Enrique Díaz de León A.C., Guadalajara, MexicoRecrutementTBI (Traumatic Brain Injury) ou MS (Sclérose en Plaques)États-Unis, Espagne
Essais cliniques sur VNS for TBI group
-
Boston Children's HospitalComplétéStress, Psychologique | Problème d'acculturationÉtats-Unis