Transcutaneous Auricular Vagus Nerve Stimulation in Patients with Stroke
30 patients around the world
Available in Colombia
Stroke is a neurological condition caused by vascular problems such as cerebral
infarction and/or intracerebral or subarachnoid hemorrhage(1). In 2019, more than 12
million strokes occurred worldwide, making it one of the leading causes of morbidity.
Motor impairment is considered one of the main problems resulting from this condition(2).
Recovery of motor function occurs spontaneously during the first months after stroke(3)
as a result of brain plasticity processes in the sensory and motor systems(4). It is
estimated that 50 to 75% of patients with stroke persist with significant motor sequelae
limiting daily activities(5).
Recently, Vagus Nerve Stimulation (VNS) has been proposed as an intervention that could
have beneficial effects in the recovery of motor function in these patients, since it
contributes to the generation of adaptive neuroplasticity and the activation of
neuromodulators that reduce brain inflammation(6).
VNS has mainly been administered by using implanted electrodes, but more recently, a
non-invasive technique, known as transcutaneous VNS (cervical or auricular) has been
proposed. VNS has traditionally required the implantation of an electrical pulse
generator at the left subclavicular level, which is connected to electrodes in the left
cervical branch of the vagus nerve(7). Its insertion is performed by a surgical
procedure, which presents a higher risk of adverse events(8), the most frequent being
dysphonia during stimulation, due to its proximity to the laryngeal nerve(9). On the
other hand, transcutaneous VNS works through the placement of non-invasive electrodes on
the neck or auricle for stimulation of the cervical or auricular branch of the vagus
nerve respectively(7). Transcutaneous VNS has a lower risk of adverse events, is
reversible and easy to implement(7). In addition, experimental evidence suggests that the
effects of transcutaneous VNS on brain function are comparable to those obtained with
VNS(8).
This study will evaluate the effects of transcutaneous vagus nerve stimulation (tVNS) in
combination with physical rehabilitation on upper limb motor function of patients with
stroke. Thirty patients with ischemic stroke will be included in the study. Subjects will
be randomized to tVNS + physical rehabilitation or sham stimulation + physical
rehabilitation. Therapy sessions will be performed 3 times a week for six consecutive
weeks. Efficacy will be evaluated by assessing the change in motor function of the upper
limb, the next day and 30 days after the end of the intervention. The motor function of
the upper limb will be assessed by means of the Fugl-Meyer scale score.
Fundación Cardiovascular de Colombia
1Research sites
30Patients around the world
This study is for people with
Stroke
Requirements for the patient
To 75 Years
All Gender
Medical requirements
Age >18 years and <75 years.
Unilateral supratentorial ischemic stroke that occurred at least 7 days but not more 30 days before enrollment.
Modified Rankin Scale between 0 and 1 before stroke.
Contralesional UL motor impairment defined by NIHSS item 5 score ≥ 1 to ≤ 3.
Ability to provide written informed consent.
Hemodynamically stable patients.
Patients residing in the metropolitan area of Bucaramanga.
Significant cognitive or language impairment that would interfere with study participation or informed consent. This criterion will be defined by NIHSS item 1a-c score > 2, item 9 score > 1, item 11 score = 2.
Medical conditions that could interfere with study participation, for example ear infections or skin wounds.
Bradycardia (< 50 bpm) or hypotension (< 90/60 mmHg).
Significant pre-existing disability.
History of stroke.
History of cardiac arrhythmia.
History of severe head trauma, brain surgery, deep brain stimulation, or brain injuries of other etiologies.
Pregnant or planning on becoming pregnant or breastfeeding during the study period.
Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent subject from meeting protocol timeline.
Subjects who are currently in another clinical trial or plan to do so during the study period.
Patient receiving any therapy at study entry that would interfere with VNS (e.g., drugs that interfere with neurotransmitter mechanisms: anticholinergics, adrenergic blockers, etc.).
Prior injury to vagus nerve.
Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug.
Sites
Hospital Internacional de Colombia
Terrazas De Menzuly, La Parcela, Piedecuesta, Santander, Colombia