EEG Changes and DNA Markers Related to taVNS in Stroke Patients: a Preliminary Study

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCasa Colina Hospital and Centers for Healthcare

About this trial

In the United States, more than 795,000 people have a stroke every year. Motor impairment after a stroke is common and can be debilitating. To date, there remain few treatments available to help improve motor recovery after a stroke, making this an important area of research. Novel use of neuromodulation such as Invasive Vagus Nerve Stimulation (VNS) has been shown to improve motor recovery in stroke patients. Vagus nerve stimulation (VNS), in which the nerve is stimulated with electrical pulses, has demonstrated success for a variety of conditions, including inflammation, depression, cognitive dysfunction, chronic fatigue, headaches/migraines, pain, insomnia, and cardiovascular issues. Very recently, non-invasive options have been developed and might be a promising alternative. The research in this area is still very limited and much more research is needed to investigate non-invasive/trancutaneous auricular vagus nerve stimulation (taVNS) related biomechanisms and to further support its efficacy in acute patients. The purpose of this study is to build upon the current research to investigate changes in electrical brain activity (using electrophysiology) and genetic markers related to improvements in both motor and cognitive recovery following the use of taVNS vs. sham in acute stroke patients.

Eligibility criteria

Qualifiers

First-time Cerebrovascular Accident (Ischemic or Hemorrhagic)

Within a month post-injury

Presence of motor impairments (FMA-U≤62)

Disqualifiers

Advanced cardiac, pulmonary, liver, or kidney disease

Bradycardia (Resting HR < 60)

Presence of Apraxia, Aphasia or confusion

Other musculoskeletal or neurologic diseases that could interfere with the outcome measures

Trial design

Treatments tested in this trial

  • Transcutaneous vagus nerve stimulation

Treatment groups

44 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Casa Colina Hospital and Centers for Healthcare

Lead sponsor

Foundation for Physical Medicine and Rehabilitation

Collaborator