At-Home taVNS - Stroke Rehab

Официальное название

Development of At-Home Transcutaneous Auricular Vagus Nerve Stimulation for Post-Stroke Rehabilitation

Обзор

Early evidence suggests the benefits of post-stroke motor rehabilitation may be enhanced by applying electrical stimulation to the ear. This study aims to test the new approach of pairing ear stimulation with motor rehabilitation in the home setting in stroke survivors with upper limb motor function deficits.

Подробное описание

This study seeks to advance prior research conducted here at MUSC exploring the use of transcutaneous auricular vagus nerve stimulation (taVNS) paired with motor rehabilitation to improve motor function post-stroke. Early evidence from a recently completed NIH-funded, clinical trial suggests that our new approach of delivering electrical stimulation to the ear at the same time as motor rehabilitation double the clinical benefits of motor rehabilitation. These benefits are due in part to a facilitation of neuroplasticity caused by activating the auricular branch of the vagus nerve.

This project takes this approach one step further, moving it into the home in combination with telerehabilitation in order to make this technology more accessible to individuals in rural and remote areas. In order to accomplish this, investigators will a) conduct lab-based testing and validation of the stimulation triggering sensors for at-home use, and b) determine the safety, feasibility, and acceptability of at-home taVNS in five stroke survivors with unilateral upper limb motor deficits.

Investigators hypothesize that our lab-based validation will facilitate an optimized home intervention. Furthermore, investigators hypothesize taVNS will be safe and feasible to self-administer in the at-home setting. Lastly, investigation will help elucidate any challenges that may occur as investigators begin to expand this technology into future larger trials

Вмешательства

• Устройство Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training
  Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.

Первичные конечные точки

• Feasibility through dropout rates [Срок оценки: 2 weeks]
• Safety of stimulation [Срок оценки: 2 weeks]
• Compliance [Срок оценки: 2 weeks]
• Subjective ratings of feasibility. [Срок оценки: 2 weeks]

Вторичные конечные точки (2)

• Compliance with at-home sessions [Срок оценки: 2 weeks]
• Motor Function [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

• 18-80 years old with an ischemic or hemorrhagic stroke that occurred ≥6 months prior;
• Ability to give consent;
• Unilateral limb (left or right) weakness with Fugl Meyer-Upper Extremity Scale score of 19-53/60 points which indicates adequate arm/hand use for rehabilitation tasks;
• active wrist flexion/extension ≥10° with active abduction/extension of thumb and at least 1 digit ≥10° to further assure ability to participate in rehabilitation tasks;
• Passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.

Критерии исключения

• Other concomitant neurological disorders affecting upper extremity motor function;
• Presence of Dysphagia or aspiration difficulties;
• Prior injury to vagus nerve;
• Pregnancy;
• Documented history of dementia before or after stroke;
• Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment;
• Uncontrolled hypertension;
• Botox injections within 4 weeks of the first day of rehabilitation therapy.

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

Публикации

• Badran BW, Peng X, Baker-Vogel B, Hutchison S, Finetto P, Rishe K, Fortune A, Kitchens E, O'Leary GH, Short A, Finetto C, Woodbury ML, Kautz S. Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study. Neurorehabil Neural Repair. 2023 Jun;37(6):374-383. doi: 10.1177/15459683231173357. Epub 2023 May 20. PMID 37209010

Идентификаторы

NCT: NCT06616831 · Pro00137256

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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