Effect of Vagus Nerve Stimulation Via the Outer Ear on Motor and Cognitive Deficits After Ischemic Stroke

Официальное название

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Motor and Cognitive Deficits After Ischemic Stroke

Обзор

The goal of this clinical trial is to learn if transcutaneous auricular vagus nerve stimulation (taVNS) works to treat motor and neurocognitive deficits after ischemic stroke when applied within 30 days after onset of stroke. The main questions it aims to answer are: * Does tVNS improve motor deficits measured by the Fugl-Mayer assessment after ischemic stroke? * Does tVNS ameliorate stroke-related cognitive impairment? Researchers will compare tVNS to a placebo (sham stimulation, i.e. an electrode is fixed on the ear without applying electrical impulses ) to see if tVNS works to treat motor and cognitive deficits after stroke . Participants will: * Receive tVNS or sham stimulation for 30 minutes 5 days a week during 5 weeks after ischemic stroke * Receive smotor and cognitive training during the tVNS or sham stimulation * Will take part on a standardized stroke rehabilitation program during the 5 weeks in a rehabilitation clinic.

Подробное описание

Study participants will undergo pre-evaluation and receive information within the first 7 days after admission to the Rheinburg-Klinik (Visit 0). During these 7 days, study participants will be randomly (1:1) allocated to the intervention group (taVNS) or control group (sham-stimulation) and will be clinically examined (Visit 1). At Visit 2 (≤7 days after admission), baseline assessments will be performed. During the intervention period, (week 2 to 6 after admission), either taVNS or sham-stimulation will be conducted for 30 minutes per day at 5 days per week for 5 weeks, paired with cognitive and motor training. Participants will be blinded to treatment. Standardized rehabilitation measures according to the clinic standards will be performed in both groups during the study period. All study participants will be monitored by recording an ECG during intervention/sham-stimulation. Before and after intervention/sham-stimulation an EEG will be conducted. After intervention, i.e., at the end of week 6, the same assessments as at baseline will be repeated (Visit 3). A follow up visit will take place 6 months after intervention.

Вмешательства

• Устройство transcutaneous auricular vagus nerve stimulation
  Stimulation parameters: * Stimulating side: ipsilateral to the infarcted brain hemisphere * Location of pStimulation: Cymba conchae * Impulse shape: bi-phasic * Impulse intensity: at least 0.5 mA (max. 2.0 mA). * Impulse duration: 28 sec on, 32 sec off * Impulse frequency: 20-30 Hz.
• Устройство sham-stimulation
  An electrode is only attached to the ear without applying electrical impulses.

Первичные конечные точки

• Fugl-Meyer-Motor-Assessment [Срок оценки: Assessed <7 days and 6 weeks after admission at the Rheinburg Klinik.]

Вторичные конечные точки (12)

• Consortium to Establish a Registry of Alzheimer's Disease (CERAD) [Срок оценки: Assessed < 7 days and 6 weeks after admission to the Rheinburg Klinik.]
• Montreal Cognitive Assessment (MoCA) [Срок оценки: Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.]
• Wechsler Adult Intelligence Scales (WAIS-IV) working memory subtests [Срок оценки: Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.]
• Digit Symbol Test [Срок оценки: Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.]
• Stroop Color and Word Test [Срок оценки: Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.]
• Self-Report Measure for the Assessment of Emotion Regulation Skills (SEK-27) [Срок оценки: Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.]
• Emotion Regulation Questionnaire (ERQ) [Срок оценки: Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.]
• Fatigue Scale for Motor and Cognitive Functions (FSMC) [Срок оценки: Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.]
• Stroke-Specific Quality of Life Scale (SS-QOL) [Срок оценки: Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.]
• Test of Attentional Performance (TAP) [Срок оценки: Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.]
• Action Research Arm Test (ARAT) [Срок оценки: Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.]

Критерии участия

Критерии включения

• Onset of stroke ≥15 days and ≤30 days after randomization
• Ischemic stroke in the anterior cerebral circulation detected by MR imaging or computer tomography
• National Institutes of Health Stroke Scale (NIHSS) score ≥3 points
• Montreal Cognitive Assessment (MoCA) score ≤ 26 points
• First ever stroke
• Right-handed
• Ability to participate in a standardized rehabilitation therapy
• Written informed consent signed by the subject or next kin

Критерии исключения

• Age < 18 years
• Pregnant and breastfeeding women
• Severe concomitant neurological (brain tumor, encephalitis, Parkinson disease, epilepsy prior to stroke onset) or mental disorders (psychiatric conditions such as schizophrenia, uncontrolled depression or bipolar disorder before stroke onset)
• Severe aphasia (i.e. unable to follow two-stage-commands)
• Pre-existing hemiparesis
• Documented history of dementia before index stroke
• Primary intracranial hematoma or subarachnoid hemorrhage
• Active implantable medical device (e.g., pacemaker, deep brain stimulator, cochlear implants, cerebral shunts)
• Metal cervical spine hardware or metallic implant near the stimulation site
• Modified Rankin scale (mRS) ≥ 2 prior to stroke onset
• Low heart rate (< 60 bpm)
• Severe vision and hearing problems
• Alcohol and drug abuse
• Active post-stroke delirium, unable to cooperate
• Type 1 and 2 diabetes mellitus
• Sore and diseased skin of the auricle
• Patients receiving any therapy (medication or otherwise) at study entry that would interfere with VNS

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Rheinburg Klinik — Walzenenhausen

Идентификаторы

NCT: NCT06822140 · 2024-D0114

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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