Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery in Subacute Stroke During Technological and Traditional Training
NCT ID: NCT07254390
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2025-01-08
2027-04-03
Brief Summary
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The Parasym® device (CE 0197) delivers non-invasive stimulation of the auricular branch of the vagus nerve at the left ear for 60 minutes daily.
The primary outcome is the improvement in upper limb motor function, assessed by the Fugl-Meyer scale. Secondary outcomes include other clinical, cognitive, and psychological measures, as well as neurophysiological and cardiovascular autonomic parameters.
The study hypothesizes that coupling tVNS with rehabilitation enhances cortical plasticity and accelerates motor recovery. Adverse effects are expected to be minimal, with previous studies reporting only mild transient skin irritation. The results may provide new insights into the neurophysiological mechanisms of recovery and support the integration of non-invasive neuromodulation in post-stroke rehabilitation.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Khymeia + Active tVNS
Active trans-auricular vagus nerve stimulation (tVNS) + Khymeia training
Active trans-auricular vagus nerve stimulation (tVNS) with the Parasym® device (CE 0197). Electrode placed on the left tragus, 25 Hz, 250 µs, intensity to tolerance, 60 min/day, 5 days/week for 4 weeks, combined with Khymeia robotic upper limb rehabilitation.
Khymeia + Sham tVNS
Sham trans-auricular vagus nerve stimulation + Khymeia training
Sham tVNS using the Parasym® device with electrodes on the left earlobe (non-vagal area). Same schedule as active tVNS, combined with Khymeia rehabilitation.
Traditional Rehabilitation + Active tVNS
Traditional Rehabilitation + Active tVNS
Active tVNS with Parasym® (left tragus, 25 Hz, 250 µs, 60 min/day, 5 days/week for 4 weeks) combined with traditional rehabilitation.
Traditional Rehabilitation + Sham tVNS
Traditional Rehabilitation + Sham tVNS
Sham tVNS with Parasym® device, electrodes on left earlobe, 60 minutes/day, 5 days/week for 4 week. Same duration and schedule, combined with traditional rehabilitation.
Interventions
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Active trans-auricular vagus nerve stimulation (tVNS) + Khymeia training
Active trans-auricular vagus nerve stimulation (tVNS) with the Parasym® device (CE 0197). Electrode placed on the left tragus, 25 Hz, 250 µs, intensity to tolerance, 60 min/day, 5 days/week for 4 weeks, combined with Khymeia robotic upper limb rehabilitation.
Sham trans-auricular vagus nerve stimulation + Khymeia training
Sham tVNS using the Parasym® device with electrodes on the left earlobe (non-vagal area). Same schedule as active tVNS, combined with Khymeia rehabilitation.
Traditional Rehabilitation + Active tVNS
Active tVNS with Parasym® (left tragus, 25 Hz, 250 µs, 60 min/day, 5 days/week for 4 weeks) combined with traditional rehabilitation.
Traditional Rehabilitation + Sham tVNS
Sham tVNS with Parasym® device, electrodes on left earlobe, 60 minutes/day, 5 days/week for 4 week. Same duration and schedule, combined with traditional rehabilitation.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Istituti Clinici Scientifici Maugeri SpA
OTHER
Responsible Party
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Locations
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ICS Maugeri - Montescano
Montescano, Pavia, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2665
Identifier Type: -
Identifier Source: org_study_id
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