Stroke
Conditions
Keywords
Transcutaneous vagus nerve stimulation (tVNS), Stroke rehabilitation, Neuroplasticity, Upper limb motor recovery, Non-invasive neuromodulation
Brief summary
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.
Interventions
DEVICEActive trans-auricular vagus nerve stimulation (tVNS)
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.
DEVICESham tVNS
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).
DEVICEKhymeia robotic upper limb rehabilitation
Robotic-assisted rehabilitation for the upper limbs using the Khymeia system.
BEHAVIORALTraditional Rehabilitation
Standard traditional physical therapy and rehabilitation protocols for upper limb recovery.
Sponsors
Istituti Clinici Scientifici Maugeri SpA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper limb motor recovery assessed by Fugl-Meyer Assessment (FMA-UE) | Baseline and 4 weeks after treatment | The FMA-UE is a scale used to measure sensorimotor impairment. Scores range from 0 to 66, where higher scores indicate better motor function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Independence Measure (FIM) | Baseline and 4 weeks. | 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. |
| Barthel Index | Baseline and 4 weeks | 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. |
| Mini-Mental State Examination (MMSE) | Baseline and 4 weeks | 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). |
| Frontal Assessment Battery (FAB) | Baseline and 4 weeks | 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. |
| Patient Health Questionnaire-9 (PHQ-9) | Baseline and 4 weeks | 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) |
| Generalized Anxiety Disorder-7 (GAD-7) | Baseline and 4 weeks | 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). |
| Somatosensory Evoked Potentials (Median Nerve) | Baseline and 4 weeks | 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. |
Countries
Italy
Contacts
CONTACTCira Fundaro'
Outcome results
None listed