Pupil-Indexed Noninvasive Neuromodulation

Официальное название

Transcutaneous Auricular Vagus Nerve Stimulation: Motor Learning & Mechanisms

Обзор

Vagus nerve stimulation (VNS) is thought to activate neural pathways that release chemicals which promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear modulates physiological indexes of brain states implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms modulated by auricular stimulation to support possible therapeutic effects in the form of motor learning.

Подробное описание

Existing evidence supports the use of VNS to enhance the effects of traditional therapy on impairments due to neurological injury. It is known that the vagus nerve forms contacts with neuromodulatory nuclei in the brainstem that release of chemicals shown to be critically involved in attentional control and memory formation. It is also known that the auricular branch of the vagus nerve innervates portions of the external ear providing a possible means to engage similar neural pathways noninvasively via transcutaneous auricular vagus nerve stimulation (taVNS). Recent work from the PI's laboratory shows that electrical current applied to landmarks on the external ear elicits transient effects on pupil dilation, an established physiological index of brain states that support learning. Given the ability to engage the biomarker, the investigators aim to further investigate physiological mechanisms modulated by taVNS and possible effects on learning.

Вмешательства

• Другое Transcutaneous Electrical Stimulation
  Electrical pulse trains applied to the skin overlying putative sites of auricular vagal innervation.
• Другое Sham
  Electrodes placed on the skin overlying putative sites of auricular vagal innervation but no current administered.

Первичные конечные точки

• Force Control Change [Срок оценки: Pre, 1-week Post, 1-month Post]

Критерии участия

Критерии включения

ALL PROSPECTIVE SUBJECTS:

• 18-75 years of age

PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:

• Diagnosis of a single stroke resulting in hand impairment
• Diagnosis of stroke at least six months prior to the time of participation

Критерии исключения

ALL PROSPECTIVE SUBJECTS:

• History of vestibular disorders or dizziness
• Difficulty maintaining alertness and/or remaining still
• Pregnant or expecting to become pregnant
• Diagnosis of neurological and/or musculoskeletal disorder(s) (other than stroke) that affect movement
• Ocular disease and/or impairment in more than one eye
• History of seizure and/or epilepsy
• Implants, devices, or foreign objects in the brain/body that are incompatible with MRI
• Body size that is incompatible with MRI scanner dimensions
• Anyone already enrolled and actively participating in another greater than minimal risk study.

PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:

• Other impairments secondary to stroke (e.g., attention, cognition, etc.) that would interfere with the ability to understand study goals or follow simple instructions, as judged by the investigators.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh

Идентификаторы

NCT: NCT06282406 · N4532-R · I0X1RX004532

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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