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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Khymeia + Sham tVNS | Sham Comparator |
| |
| Traditional Rehabilitation + Active tVNS | Experimental |
| |
| Traditional Rehabilitation + Sham tVNS | Sham Comparator |
| |
| Khymeia + Active tVNS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active trans-auricular vagus nerve stimulation (tVNS) | Device | Active 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Upper limb motor recovery assessed by Fugl-Meyer Assessment (FMA-UE) | The FMA-UE is a scale used to measure sensorimotor impairment. Scores range from 0 to 66, where higher scores indicate better motor function. | Baseline and 4 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measure (FIM) | The FIM assesses the physical and cognitive disability of a patient. Total scores range from 18 to 126, where higher scores indicate greater independence in activities of daily living. | Baseline and 4 weeks. |
| Barthel Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cira Fundaro' | Contact | 0385247268 | cira.fundaro@icsmaugeri.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICS Maugeri - Montescano | Recruiting | Montescano | Pavia | 27040 | Italy |
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| Sham tVNS | Device | Sham tVNS using the Parasym® device with electrodes on the left earlobe (non-vagal area). Same schedule as active tVNS (60 min/day, 5 days/week for 4 weeks). |
|
| Khymeia robotic upper limb rehabilitation | Device | Robotic-assisted rehabilitation for the upper limbs using the Khymeia system. |
|
| Traditional Rehabilitation | Behavioral | Standard traditional physical therapy and rehabilitation protocols for upper limb recovery. |
|
The Barthel Index measures the extent to which a person can function independently and has mobility in activities of daily living (ADL). The total score ranges from 0 to 100, where higher scores indicate better performance and greater independence. |
| Baseline and 4 weeks |
| Mini-Mental State Examination (MMSE) | The MMSE is a 30-point questionnaire used to measure cognitive impairment. Scores range from 0 to 30, where higher scores indicate better cognitive function (scores ≥24 are typically considered normal). | Baseline and 4 weeks |
| Frontal Assessment Battery (FAB) | The FAB is a brief tool to assess frontal lobe functions (executive functions). Total scores range from 0 to 18, where higher scores indicate better executive performance. | Baseline and 4 weeks |
| Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a multipurpose instrument for screening, monitoring, and measuring the severity of depression. Scores range from 0 to 27. Higher scores indicate worse outcome (greater severity of depressive symptoms) | Baseline and 4 weeks |
| Generalized Anxiety Disorder-7 (GAD-7) | The GAD-7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. Scores range from 0 to 21. Higher scores indicate worse outcome (greater severity of anxiety symptoms). | Baseline and 4 weeks |
| Somatosensory Evoked Potentials (Median Nerve) | Evaluation of the N20 peak latency (measured in milliseconds) and/or the N20-P25 amplitude (measured in microvolts) of the Somatosensory Evoked Potentials following stimulation of the median nerve at the wrist. Lower latency values and higher amplitude values indicate better neurological conduction and somatosensory pathway integrity. | Baseline and 4 weeks |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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