Stroke
Conditions
Keywords
trans-auricular vagus nerve stimulation, stroke, upper extremity function
Brief summary
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.
Interventions
DEVICEActive taVNS
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.
DEVICESham taVNS
Physical therapy focused on upper extremity function with masking for transcutaneous vagus nerve stimulation
Sponsors
Fundação de Amparo à Ciência e Tecnologia de Pernambuco
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Universidade Federal de Pernambuco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
* Patients with any contraindication to taVNS, peripheral upper extremity injuries, use of medication affecting cortical excitability in the past 3 months, use of botulinum toxin in the past 3 months, presence of any other neurological disorder, or significant cognitive deficits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper extremity Motor Function (Fugl-Meyer Assessment - Upper Extremity) | Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Independence (Functional Independence Measure) | Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10) | 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. |
| Spasticity (Modified Ashworth Scale) | Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10) | 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. |
| Manual Dexterity (Box and Block Test) | Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10) | 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. |
| Multidimensional Stroke Impact (Stroke Impact Scale) | Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10) | 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. |
| Global Perception of Change (Patient Global Impression of Change) | Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10) | 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. |
| Health-Related Quality of Life (Stroke-Specific Quality of Life Scale) | Baseline (day 0), mid-intervention (day 5), post-intervention (day 10) | 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. |
Countries
Brazil
Contacts
Primary ContactDANIEL G DE MELO, MsC
Backup ContactGabriel Barreto, PhD
Outcome results
None listed