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Идёт набор NCT07517237

taVNS + CCT for Neurocognitive Rehab

Без фазы С лечением Psychosocial Well-being Neurocognitive Function Cognitive Complaint Cognitive Dysfunction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: taVNS, Computerized Cognitive Training.
Кому может быть актуально
Состояния в реестре: Psychosocial Well-being, Neurocognitive Function, Cognitive Complaint, Cognitive Dysfunction. Базовые параметры: 45 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Combining At-Home Transcutaneous Auricular Vagus Nerve Stimulation and Computerized Cognitive Training for Neurocognitive Rehabilitation

Обзор

The purpose of this study is to investigate whether combining transcutaneous auricular vagus nerve stimulation (taVNS) with computerized cognitive training might help improve thinking abilities and mood. Participants will self-administer these treatment in their homes and undergo pre- and post-treatment assessments of thinking abilities and mood and brain MRIs.

Подробное описание

This is a non-randomized, single arm pilot study of a 2-week at-home treatment combining transcutaneous auricular vagus nerve stimulation (taVNS) with computerized cognitive training (CCT) in people with subjective cognitive and psychosocial complaints. The primary objectives are to evaluate the feasibility, acceptability, and preliminary effects of this treatment on cognition, mood, psychosocial function, and brain function.

Вмешательства

  • Устройство taVNS
    A Soterix Medical Handheld home-based taVNS device combined with web-based adaptive computerized cognitive training (CCT) will be self-administered for 10, 1 hour treatment sessions at home. CCT will be accessed via the web from a tablet or computer. The premise of a combined approach is that taVNS "primes" brain networks that are then engaged by CCT, synergistically enhancing cognitive benefits.
  • Устройство Computerized Cognitive Training
    CCT will be delivered through the online BrainHQ platform. Participants will engage in adaptive visual speed of processing training for approx. 30 minutes per session (10 sessions, total CCT time = 300 min).

Первичные конечные точки

  • Retention [Срок оценки: From enrollment to the V2 post-treatment assessment (approximately 6 weeks).]
  • Adherence [Срок оценки: 10 treatments (T1-T10) over max span of 14 days.]
  • Acceptability [Срок оценки: V1 (1 week pre-treatment), V2 (1 week post-treatment)]
Вторичные конечные точки (3)
  • Change in NIH Toolbox-Cognition Battery (NIHTB-CB) Fluid Composite [Срок оценки: V1 (1 week pre-treatment), V2 (1 week post-treatment)]
  • Change in PROMIS Cognitive Function, Depression, Anxiety, and Fatigue T-scores [Срок оценки: V1 (1 week pre-treatment), V2 (1 week post-treatment)]
  • Change in Network Functional Connectivity [Срок оценки: V1 (1 week pre-treatment), V2 (1 week post-treatment)]

Критерии участия

Критерии включения

i. Ages 45-80 (inclusive) ii. Adequate sensorimotor function (including motor function of dominant hand to complete CCT) and verbal expressive abilities to complete all assessments.

iii. Access to reliable Wi-Fi and a Bluetooth-enabled mobile phone or tablet with internet connection capable of supporting study procedures.

iv. Self-reported change in cognitive functioning (e.g., memory, attention, thinking abilities) compared to prior functioning, persisting ≥ 6 months and associated with concern and/or impact on daily functioning.

v. Is on fixed pharmacotherapy (i.e. stable dose of medication/s) for ≥ 4 weeks before enrollment, and expected to remain stable throughout study participation. This includes, but is not limited to, cholinesterase inhibitors, NMDA receptor antagonists, and antidepressants.

Критерии исключения

i. Prior diagnosis of Mild Cognitive Impairment or Dementia (NIA-AA) or Mild or Major Neurocognitive Disorder (DSM-5).

ii. taVNS contraindications (e.g., history of seizures, history of trauma or damage to ear, reduced/impaired sensation in the ear).

iii. MRI contraindications (e.g., ferromagnetic implants, claustrophobia). iv. Presence of a neurological, medical, or psychiatric condition that is acute, unstable, or severe, and that, in the judgment of the study investigators, would significantly interfere with safe participation, valid assessment of cognition or mood, or interpretation of study outcomes.

v. Enrolled in a clinical trial or has received an investigational medication or device in the last 30 days that may impact cognition or mood.

vi. For female participants, a positive pregnancy test if still menstruating within the past 12 months.

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

США · 1 центр
  • Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT07517237 · Pro00144863

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗