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New treatment option for Stroke
Official title Non-invasive VNS in Stroke Recovery
ClinicalTrials.gov ID: NCT06761404
What this study is testing
- What it's testing
- To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language...
- Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury...
- people 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...
- Patients with unstable cardiac arrhythmia, reentry tachycardia.
- Pregnancy
See the full eligibility 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...
- Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury etc.)
- people 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.