taVNS Paired With Motor Training for Upper-extremity Rehabilitation in Stroke Patients

Launched by QIUYOU XIE · Jul 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help stroke patients improve their arm and hand function using a technique called transcutaneous auricular vagus nerve stimulation (taVNS) combined with motor training. The goal is to see if this non-invasive method can effectively support rehabilitation without the need for surgery, which is required in traditional vagus nerve stimulation. The trial will involve 150 participants who will be randomly assigned to different groups to receive various combinations of taVNS and motor training over 14 sessions.

To be eligible for the trial, participants must be adults aged 18 to 80 who have had an ischemic stroke and are in the recovery phase (at least two weeks after the stroke). They should have problems with one arm but no serious mental health issues or other medical conditions that could interfere with the study. Participants can expect to engage in targeted motor training exercises while receiving taVNS, with their progress monitored throughout the trial. This study aims to find out if taVNS can be a safe and effective tool for improving arm function in stroke recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients diagnosed with ischemic stroke according to a clinically qualified physician with reference to the Chinese Stroke Prevention and Control Guideline (2021).
• • Patients in the acute/recovery phase (after 2 weeks of onset) with stable signs;
• • No previous neuropsychiatric-related diseases;
• • No significant impairment of cognitive function and able to cooperate in completing the corresponding rehabilitation training;
• • With unilateral upper limb dysfunction;
• • Patients who have not received various neuromodulation rehabilitation treatments;
• • No contraindications to taVNS;
• • Patients voluntarily cooperated with the study and signed an informed consent form.
• Exclusion Criteria:
• • Patients have other mental health disorders (dementia, Parkinson's disease, depression, schizophrenia, bipolar disorder, etc.)
• • Patients have uncontrolled epilepsy, i.e., having had a seizure within 4 weeks prior to enrollment
• • Patients have cardiac arrhythmias or other abnormalities
• • Patients have a history of respiratory disease or disorder, including dyspnea and asthma;
• • The presence of gastrointestinal disorders such as diarrhea and vomiting that make it difficult for the patient to cooperate
• • Patients have a history of vasovagal syncope
• • Patients are under treatment with other neurostimulation/modulation
• • The presence of severe spasticity, other serious injuries to the upper extremities, or other medical conditions
• • Patients have difficulty in communication and understanding and inability to cooperate in completing the test;
• • Women who are pregnant or breastfeeding.