Non-invasive VNS in Stroke Recovery

Launched by THE METHODIST HOSPITAL RESEARCH INSTITUTE · Dec 31, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called non-invasive vagus nerve stimulation (VNS) to help people recover from strokes. Researchers want to see if this method can improve recovery for individuals who have experienced a stroke and have weakness on one side of their body (known as hemiparesis). The trial is not yet recruiting participants, but it will include adults aged 18 and older, regardless of gender or ethnicity, who are at least six months post-stroke and can follow simple instructions.

To join the study, participants must have experienced a specific type of stroke confirmed by medical imaging and show certain levels of mobility in their affected arm. However, those with severe mental health issues, other serious medical conditions, or certain physical limitations won't be eligible. Participants will undergo non-invasive stimulation and may need to attend several appointments. This trial aims to find out if this approach can really make a difference in stroke recovery, and it could lead to new treatment options for many individuals.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Symptomatic ischemic or hemorrhagic stroke verified by computerized axial tomography or magnetic resonance imaging resulting in hemiparesis (MRC 1-4).
• • Age more than 18, Male or Female, All racial and ethnic groups
• • Entry into the study \>6 months post onset
• • Patients who can safely undergo taVNS
• • Able to follow 2 step commands
• • Modified Ashworth Scale Score =\<3 in the involved upper extremity
• • Passive range of motion within functional ranges at the shoulder, elbow, wrist and hand
• • UFM =\< 60 (scale 0-66)
• Exclusion Criteria:
• • Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as unable to follow study instructions).
• • Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury etc.)
• • Subjects with contraindication to MRI of the brain
• • Patients with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, epilepsy or others).
• • Patients with unstable cardiac arrhythmia, reentry tachycardia.
• • Pregnancy
• • Patients with pacemakers or stimulators that interfere with the stimulation, or other investigational devices or drugs
• • Non-English speaking individuals will only be eligible if they can provide the appropriate translator for all the sessions of the study as no funding is available to pay for such services. However we plan to include them once funding has been secured in the subsequent larger trial.