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.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Sima Mofakham, PhD
- Numer telefonu: 631-444-1278
- E-mail: sima.mofakham@stonybrookmedicine.edu
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: VNS Group
Group to be implanted with VNS devices
|
Group will be implanted with VNS device for chronic TBI
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of Participants With Device- or Procedure-Related Adverse Events
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Disability Rating Scale (DRS) Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 1 Year
|
EQ-5D-5L index score (range 0 [death] to 1 [full health]; higher scores indicate better quality of life).
|
1 Year
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Q251552
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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