BridgeMD
New treatment option for Stroke
Official title Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery in Subacute Stroke During Technological and Traditional Training
ClinicalTrials.gov ID: NCT07254390
What this study is testing
- What it's testing
- This randomized pilot clinical study aims to investigate the effects of trans-auricular vagus nerve stimulation (tVNS) on neuromotor recovery in patients in the subacute phase after stroke. Participants admitted for intensive rehabilitation at ICS Maugeri Centers (Montescano, Pavia, Nervi) will be randomized into four groups receiving either traditional or technological rehabilitation (Khymeia device), combined with active or sham tVNS.
- Which group you join is decided by chance.
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
- Patients with hemiplegia following ischemic or hemorrhagic stroke occurred within the previous 6 months, clinically stable
- Age ≥ 18 years
- Single cortical or subcortical lesion documented on neuroimaging, corresponding to the motor deficit
- Cognitively able to understand and follow therapeutic instructions
- Upper limb weakness confirmed by a Motricity Index score below maximum
You likely can't join if
- Multiple brain lesions on neuroimaging
- Severe spasticity (Modified Ashworth Scale 3-4)
- Aphasia preventing comprehension of verbal instructions
- Cognitive decline or behavioral disorders interfering with collaboration during training
- Orthopedic conditions or surgical outcomes preventing the execution of the rehabilitation training
See the full eligibility criteria
- Patients with hemiplegia following ischemic or hemorrhagic stroke occurred within the previous 6 months, clinically stable
- Age ≥ 18 years
- Single cortical or subcortical lesion documented on neuroimaging, corresponding to the motor deficit
- Cognitively able to understand and follow therapeutic instructions
- Upper limb weakness confirmed by a Motricity Index score below maximum
- Spasticity, if present, compatible with limb function (Modified Ashworth Scale ≤ 2)
- Written informed consent provided
- Multiple brain lesions on neuroimaging
- Severe spasticity (Modified Ashworth Scale 3-4)
- Aphasia preventing comprehension of verbal instructions
- Cognitive decline or behavioral disorders interfering with collaboration during training
- Orthopedic conditions or surgical outcomes preventing the execution of the rehabilitation training
The study team makes the final eligibility decision.
Where it's taking place
- Montescano, Pavia, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Montescano, Pavia, Italy. 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.