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| Name | Class |
|---|---|
| Fundação de Amparo à Ciência e Tecnologia de Pernambuco | OTHER |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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The aim of this clinical trial is to determine if trans-auricular vagus nerve stimulation (taVNS) is effective in improving upper extremity function in stroke survivors. The primary objectives include: Investigating whether taVNS improves motor function in stroke survivors. The secondary objectives include: Assessing any potential side effects associated with the method. Investigating taVNS effects on daily routine functions and spasticity Researchers will conduct a comparative analysis between taVNS and a sham procedure (which mimics the stimulation without any actual effect) to assess its effectiveness. Participants in the trial will: Undergo taVNS combined with physical therapy or a sham procedure with physical therapy daily over a two-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active transcutaneous vagus nerve stimulation stimulation (taVNS) | Experimental |
| |
| Sham transcutaneous vagus nerve stimulation stimulation (s-tAVNS) | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active taVNS | Device | Protocol uses a 25 Hz frequency with 500 μs pulse width in biphasic configuration, operating at a 1:1 duty cycle with current intensity set to the maximum tolerable level without inducing pain. The total stimulation duration is 60 minutes. The stimulation is combined with physical therapy focused on upper extremity function. |
| Measure | Description | Time Frame |
|---|---|---|
| Upper extremity Motor Function (Fugl-Meyer Assessment - Upper Extremity) | The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) will be used to evaluate motor impairment and recovery of the paretic upper extremity. It consists of items from sections III and IV, assessing motor function, coordination, and speed, with a maximum score of 66 points. Higher scores indicate lower motor impairment. A minimal clinically important difference (mCID) is defined as a change (Δ) of 5 or more points between baseline and post-intervention scores. | Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Manual Dexterity (Box and Block Test) | The Box and Block Test (BBT) will assess manual dexterity of the paretic upper extremity. It counts the number of wooden blocks (2.5 x 2.5 x 2.5 cm) transferred from one compartment to another over a central divider within one minute. The minimal detectable change (MDC) is defined as a difference of 5 blocks per minute. | Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10) |
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Inclusion Criteria:
Patients aged between 18 and 75 years, with motor impairment in the upper extremity caused by unilateral ischemic or hemorrhagic stroke with stroke onset within the last five years.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DANIEL G DE MELO, MsC | Contact | +5581995173332 | +55 | gmelodaniel@gmail.com |
| Gabriel Barreto, PhD | Contact | 83996106134 | +55 | gbarretoantonino@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kátia Monte-Silva, PhD in Neurosciences | Universidade Federal de Pernambuco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Pernambuco | Recruiting | Recife | Pernambuco | 50670-901 | Brazil |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sham taVNS | Device | Physical therapy focused on upper extremity function with masking for transcutaneous vagus nerve stimulation |
|
| Independence (Functional Independence Measure) | The Functional Independence Measure (FIM) assesses the level of independence through motor and cognitive subscales. Each item is scored from 1 to 7. Total score classifications: complete dependence (18-45), moderate independence (46-99), and complete independence (100-126). The MDC is defined as 17 points for the motor section, 3 points for the cognitive section, and 22 points for the total score. | Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10) |
| Spasticity (Modified Ashworth Scale) | The Modified Ashworth Scale (MAS) will assess spasticity in finger, wrist, elbow, and shoulder flexors of the paretic upper extremity. It uses a 6-point scale (0 to 5) to quantify muscle tone. The minimal clinically important difference (mCID) is defined as a reduction of at least one point in spasticity score. | Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10) |
| Health-Related Quality of Life (Stroke-Specific Quality of Life Scale) | The Stroke-Specific Quality of Life Scale (SS-QOL) assesses stroke-related quality of life across 12 domains, using 49 items. Scores range from 49 to 245, with higher scores indicating better quality of life. The MDC is 4.7 points for the total score, 2.1 for the physical subscore, and 2.8 for the psychosocial subscore. | Baseline (day 0), mid-intervention (day 5), post-intervention (day 10) |
| Multidimensional Stroke Impact (Stroke Impact Scale) | The Stroke Impact Scale (SIS) is a self-reported questionnaire assessing multiple consequences of stroke including strength, hand function, mobility, ADLs/IADLs, memory and thinking, communication, emotion, and social participation. It is designed to capture the broader impact of stroke on health and quality of life. | Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10) |
| Global Perception of Change (Patient Global Impression of Change) | The Global Perception of Change Scale (also referred to as Patient Global Impression of Change - PGIC) assesses the participant's perceived improvement at post-intervention. It includes 7 options, ranging from "no change or condition worsened" to "a great deal better, considerable improvement that made all the difference". A higher value indicates a higher perceived improvement. | Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |