StrokeNCT07132021
Efficacy of Trans-auricular Vagus Nerve Stimulation on Upper Extremity Motor Recovery in Stroke Survivors
A study testing Active taVNS in people with Stroke, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Active taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Pernambuco
Recife, Pernambuco, 50670-901
DANIEL G DE MELO, MsC, 81995173332 ext. + 55, gmelodaniel@gmail.com
About this study
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
- Being tested
- Active taVNS, Sham taVNS
- Keywords
- trans-auricular vagus nerve stimulation, stroke, upper extremity function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active taVNSDevice
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.
Sham taVNSDevice
Physical therapy focused on upper extremity function with masking for transcutaneous vagus nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active transcutaneous vagus nerve stimulation stimulation (taVNS) | Experimental | Not described Receives: Device: Active taVNS |
| Sham transcutaneous vagus nerve stimulation stimulation (s-tAVNS) | Sham comparator | Not described Receives: Device: Sham taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10)
Secondary outcomes (6)
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.
Measured: Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Aug 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Ciência e Tecnologia de Pernambuco, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
- Investigators
- Kátia Monte-Silva, PhD in Neurosciences, Study director, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132021
- Sponsor's protocol ID
- taVNS_UpperExtremity
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Trans-auricular Vagus Nerve Stimulation on Upper Extremity Motor Recovery in Stroke Survivors
- ClinicalTrials.gov ID
- NCT07132021
- Acronym / sponsor ID
- taVNS_UpperExtremity
- Conditions
- Stroke
- Keywords
- trans-auricular vagus nerve stimulation, stroke, upper extremity function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Ciência e Tecnologia de Pernambuco, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active transcutaneous vagus nerve stimulation stimulation (taVNS) | Experimental | Device: Active taVNS |
| Sham transcutaneous vagus nerve stimulation stimulation (s-tAVNS) | Sham comparator | Device: Sham taVNS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active taVNSProtocol 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 | Active transcutaneous vagus nerve stimulation stimulation (taVNS) |
| Sham taVNSPhysical therapy focused on upper extremity function with masking for transcutaneous vagus nerve stimulation | Device | Sham transcutaneous vagus nerve stimulation stimulation (s-tAVNS) |
Primary outcome
Upper extremity Motor Function (Fugl-Meyer Assessment - Upper Extremity)
Time frame: 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.
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kátia Monte-Silva, PhD in Neurosciences study director
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active taVNS in people with Stroke, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DANIEL G DE MELO, MsC (+5581995173332 ext. +55, gmelodaniel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremity Motor Function (Fugl-Meyer Assessment - Upper Extremity) (time frame: Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.