Paired VNS For TBI Rehabilitation

Обзор

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 chronic moderate to severe traumatic brain injury (TBI) and subsequent motor deficits. 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. If the results are promising, future studies plan to also include patients with acute TBI. Participation is voluntary. All participants will be carefully evaluated to determine eligibility, and informed consent will be obtained before enrollment.

Вмешательства

• Устройство VNS for TBI group
  Group will be implanted with VNS device for chronic TBI

Первичные конечные точки

• Number of Participants With Device- or Procedure-Related Adverse Events [Срок оценки: 6 Weeks]
• Change in Upper Limb Range of Motion as Assessed by SeeMe Movement Analysis [Срок оценки: 6 Weeks]

Вторичные конечные точки (6)

• Change in Disability Rating Scale (DRS) Score [Срок оценки: 1 Year]
• Change in Coma Recovery Scale-Revised (CRS-R) Score [Срок оценки: 6 Weeks]
• Change in Wolf Motor Function Test (WMFT) Performance Time [Срок оценки: 6 Weeks]
• Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) Score [Срок оценки: 6 Weeks]
• Change in Motor Activity Log (MAL) Score [Срок оценки: 1 Year]
• Change in EQ-5D-5L Index Score [Срок оценки: 1 Year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07719829 · Q251552

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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