No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
The Methodist Hospital Research Institute · Other
Who this trial is looking for
This trial is looking for adults who have had a stroke and experience weakness on one side of their body. Participants will undergo a treatment called non-invasive VNS to see if it can help improve their recovery.
Are You a Good Fit for This Trial?
You may be able to join if
I have had a stroke verified by imaging.
I am over 18 years old.
It's been more than 6 months since my stroke.
I can follow two step commands.
I have some movement in my affected arm.
My arm can move within functional ranges.
My upper extremity score is 3 or less.
My upper extremity function score is 60 or less.
You may not be able to join if
I have a history of severe alcohol or drug abuse.
I have severe depression or other psychiatric illnesses.
I have weakness on both sides of my body.
I have conditions that prevent me from having an MRI.
I have serious medical problems like uncontrolled heart disease.
I am pregnant.
I have a pacemaker or similar devices that interfere with treatment.
I cannot provide a translator if I don't speak English.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery
Trial Locations
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Status
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 c…
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.
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