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Recruiting NCT07132021

Efficacy of Trans-auricular Vagus Nerve Stimulation on Upper Extremity Motor Recovery in Stroke Survivors

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active taVNS, Sham taVNS.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device Active 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.
  • Device Sham taVNS
    Physical therapy focused on upper extremity function with masking for transcutaneous vagus nerve stimulation

Primary outcome measures

  • Upper extremity Motor Function (Fugl-Meyer Assessment - Upper Extremity) [Time frame: Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10)]
Secondary outcome measures (6)
  • Manual Dexterity (Box and Block Test) [Time frame: Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10)]
  • Independence (Functional Independence Measure) [Time frame: Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10)]
  • Spasticity (Modified Ashworth Scale) [Time frame: Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10)]
  • Health-Related Quality of Life (Stroke-Specific Quality of Life Scale) [Time frame: Baseline (day 0), mid-intervention (day 5), post-intervention (day 10)]
  • Multidimensional Stroke Impact (Stroke Impact Scale) [Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10)]
  • Global Perception of Change (Patient Global Impression of Change) [Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Federal University of Pernambuco — Recife

Identifiers

NCT: NCT07132021 · taVNS_UpperExtremity

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗