NCT06895005

Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Stroke

Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation on Upper Limb Motor Recovery After Stroke

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fundación Cardiovascular de Colombia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effects of transcutaneous vagus nerve stimulation in combination with physical rehabilitation on upper limb motor function of patients with stroke.

Detailed description

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.

Conditions

• Motor Impairment
• Motor Impairments
• Stroke
• Stroke; Sequelae
• Stroke, Ischemic

Interventions

Type	Name	Description
DEVICE	Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy	Transcutaneous auricular vagus nerve stimulation using INPULSE 3 times a week for six consecutive weeks. The stimulation parameters will be a frequency of 30Hz with a pulse width of 300 us and a stimulation time of 1.5 seconds for each respiratory cycle. The electrical current will be gradually increased to a maximum of 5 mA (0.25-mA increments) to allow adaptation to the stimulation until a comfortable tolerance level is achieved. Patients will receive physical rehabilitation therapy during stimulation, which will include reaching and grasping exercises, gross movements, turning objects, simulating specific tasks, inserting objects, opening and closing containers.
OTHER	sham stimulation + rehabilitation therapy	Patients will receive physical rehabilitation therapy during placebo stimulation (No electrical stimulation), including reaching and grasping exercises, gross movements, turning objects, simulating specific tasks, inserting objects, opening and closing containers.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-11-24
• Completion: 2025-12-24
• First posted: 2025-03-26
• Last updated: 2025-03-30

Locations

1 site across 1 country: Colombia