Effect of Non-invasive Vagus Nerve Stimulation on Cerebrovascular Reactivity and Cognition in Chronic Stroke Patients

Обзор

This study will be conducted to assess the effect of non-invasive vagus nerve stimulation on cerebrovascular reactivity and cognition in chronic stroke patients

Подробное описание

Stroke is a leading cause of disability worldwide, resulting in physical, cognitive, and emotional impairments. These impairments significantly affect individuals, families, and communities. It imposes a substantial social and financial burden on healthcare systems and economies. Deficits in cognitive functions are highly associated with reduced treatment outcomes after stroke. This interferes with social and occupational recovery and limit psychosocial functioning.

Introducing new therapeutic methods such as non-invasive vagus nerve stimulation (VNS) alongside traditional rehabilitation is essential for enhancing cognitive function after stroke. Vagus nerve stimulation can be invasive or non-invasive. Non-invasive method of VNS via transcutaneous stimulation of the peripheral auricular branch of the Vagus nerve (taVNS) is safer, better-tolerated method for delivering VNS with the same effect of invasive VNS.

There are few key human studies that assessed the effects of transcutaneous vagus nerve stimulation (tVNS) on cerebrovascular reactivity (CVR) and cognition in chronic stroke patients. Up to our knowledge, this is the first Egyptian study that will assess the effect of transcutaneous vagus nerve stimulation on cerebrovascular reactivity and cognition in chronic stroke patients. This study will hopefully be of benefit in the physical therapy field. This may guide rehabilitation programs of physical therapy toward better results.

Вмешательства

• Устройство Trans-auricular vagus nerve stimulation
  Transcutaneous vagal nerve stimulation will be done through EME Therapic 9200 electrotherapy device (EME Physio, Via degli Abeti 88/161122 Pesaro (PU), Italy). A clip electrode will be applied on cymba conchae of left ear. Stimulation parameters will be set to 30 minutes treatment time, a pulse width of 300 microseconds, pulse frequency 30 HZ and a pulsed mode with a duty cycle of 50% (30 sec on and 30 sec off time).
• Устройство Sham trans-auricular vagus nerve stimulation
  Patients will receive false trans-auricular vagus nerve stimulation through EME Therapic 9200 electrotherapy device (EME Physio, Via degli Abeti 88/161122 Pesaro (PU), Italy). The ear clip electrode will be attached to the center of the left earlobe of the patient, as it is free from vagus innervation. Stimulation parameters will be set to 30 minutes treatment time, a pulse width of 300 microseconds, pulse frequency 30 HZ and a pulsed mode with a duty cycle of 50% (30 sec on and 30 sec off time)
• Другое Conventional physical therapy
  The physical therapy program will include strengthening exercises to the antispastic muscles, stretching exercises to spastic muscles, gait training exercises, proprioceptive neuromuscular facilitation exercises for upper limb and lower limb, and graduated balance exercise.
• Устройство Computer based cognitive rehabilitation training
  * RehaCom (Dr. G. Schuhfrted Ges.m.b.II., model No. A-2340 device) will be used in this study for assessment and training two cognitive domains: attention/concentration and figural memory. Each patient will be in a comfortable sitting position in front of a screen during the session. The two domains will be assessed at the end of each session. * Attention/concentration domain (AC) includes 24 levels of difficulty. Assessment will start at level one and will be advanced to more challenging levels

Первичные конечные точки

• Breathing holding index [Срок оценки: 4 weeks]

Вторичные конечные точки (3)

• Montreal Cognitive Assessment Scale (MOCA): [Срок оценки: 4 weeks]
• Attention/concentration domain (AC) [Срок оценки: 4 weeks]
• Figural memory domain [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• Forty chronic ischemic hemiparetic patients, of both sexes, will represent the sample.
• The patient's age will range from 50 to 60 years old.
• Duration of illness will range from six months to twelve months.
• Patients with mild cognitive impairment according to Montreal Cognitive Assessment (MoCA) scale (from 18 to 25).
• Spasticity will be 1 or 1+ according to Modified Aschworth scale.
• Educated patients.

Критерии исключения

• The patients will be excluded if they have one of the followings:
• Patients with other neurological disease that affect cognition.
• Visual, verbal or hearing impairments that can interfere with communication.
• Depression assessed by Hamilton Depression Scale (Ham-D).
• Patients with poor bone window.
• History of psychiatric disease.
• Hemorrhagic stroke patients.
• Uncontrolled blood pressure or low heart rate.
• Uncontrolled diabetes (>130 mg/dL especially if consistently over 150 to 160 mg/dL)
• Patients with any taVNS contraindications (open heart surgery, pacemaker or other implants, previous surgical intervention on Vagus nerve, Facial or ear pain, and recent ear trauma)
• Stroke patients with severe cognitive impairment.
• Uncooperative patients.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Ahmed Safwat Kamal — Cairo

Идентификаторы

NCT: NCT07626242 · P.T.REC/012/006121

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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