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

NCT07132021 | Recruiting

• 1 other identifier: taVNS_UpperExtremity
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

trans-auricular vagus nerve stimulation; stroke; upper extremity function

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• Manual Dexterity (Box and Block Test)

  Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10)

• Independence (Functional Independence Measure)

  Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10)

• Spasticity (Modified Ashworth Scale)

  Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10)

• Health-Related Quality of Life (Stroke-Specific Quality of Life Scale)

  Baseline (day 0), mid-intervention (day 5), post-intervention (day 10)

• Multidimensional Stroke Impact (Stroke Impact Scale)

  Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10)

Study Arms (2)

Active transcutaneous vagus nerve stimulation stimulation (taVNS)

EXPERIMENTAL

Device: Active taVNS

Sham transcutaneous vagus nerve stimulation stimulation (s-tAVNS)

SHAM COMPARATOR

Device: Sham taVNS

Interventions

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.

Active transcutaneous vagus nerve stimulation stimulation (taVNS)

Sham taVNS DEVICE

Physical therapy focused on upper extremity function with masking for transcutaneous vagus nerve stimulation

Sham transcutaneous vagus nerve stimulation stimulation (s-tAVNS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Ciência e Tecnologia de Pernambuco: collaborator

Study Sites (1)

Federal University of Pernambuco

Recife, Pernambuco, 50670-901, Brazil

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kátia Monte-Silva, PhD in Neurosciences

  Universidade Federal de Pernambuco

  STUDY DIRECTOR

Central Study Contacts

DANIEL G DE MELO, MsC

CONTACT

+5581995173332; gmelodaniel@gmail.com

Gabriel Barreto, PhD

CONTACT

83996106134; gbarretoantonino@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 20, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)