RECRUITING

Non-invasive VNS in Stroke Recovery

Conditions

Stroke taVNS trans-auricular non-invasive vagus nerve stimulation stroke recovery neuromodulation rehabilitation chronic stroke

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery

Official Title

Non-invasive VNS in Stroke Recovery

Quick Facts

Study Start:2025-04-15

Study Completion:2028-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06761404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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.

Inclusion Criteria

Exclusion 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)

* 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.

Contacts and Locations

Study Contact

Sergio Ibarra Cortez, MD

CONTACT

346-238-2494

shibarracortez@houstonmethodist.org

Rachel Markley, MPH

CONTACT

7134413770

rmarkley@houstonmethodist.org

Principal Investigator

Timea Hodics, MD

PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Study Locations (Sites)

Houston Methodist Research Institute

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

Timea Hodics, MD, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-15

Study Completion Date2028-06-01

Study Record Updates

Study Start Date2025-04-15

Study Completion Date2028-06-01

Terms related to this study

Keywords Provided by Researchers

taVNS
trans-auricular
non-invasive vagus nerve stimulation
stroke recovery
neuromodulation
rehabilitation
chronic stroke

Additional Relevant MeSH Terms

Stroke