StrokeNCT07253870
Comperative Effects of Transcutaneous Auricular and Cervical Vagus Nerve Stimulation in Subacute Stroke Patients
A study testing Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises and Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercises in people with Stroke and Stroke, Acute, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
Trial summary
This study aims to determine whether transcutaneous vagus nerve stimulation (tVNS) via auricular or cervical branches enhances recovery when combined with task-specific training in subacute stroke patients. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Stroke, Stroke, Acute
- What is being tested?
- Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises and Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Nov 2025to 20 Jun 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First ever ischemic stroke
- Subacute phase of stroke 3-6 months post onset
- Fugl-Meyer Assessment-Upper Extremity (FMA-UE) scores ranged from 20 - 50
Who cannot join
- Previous injury or surgical intervention of vagus nerve
- Patients with cardiac arrest and arrythmias
- Uncontrolled hypertension
- Apraxia
- Other neurologic or musculoskeletal diseases
- Presence of implanted electronic devices
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Shadman Medical Center, Stroke Rehabilitation
Lahore, Punjab Province, 54660
About this study
Official title: Comparative Effects of Transcutaneous Auricular and Cervical Vagus Nerve Stimulation on Upper Limb Function, Cognition and Quality of Life in Subacute Stroke Patients
This study aims to determine whether transcutaneous vagus nerve stimulation (tVNS) via auricular or cervical branches enhances recovery when combined with task-specific training in subacute stroke patients. We anticipate finding that both stimulation methods may improve upper limb motor function compared to conventional therapy. The research is expected to reveal specific cognitive domains (attention, memory, executive function) that benefit most from each stimulation approach, while also demonstrating meaningful improvements in patients' quality of life measures. These findings may make a significant practical contribution by providing clinicians with evidence-based guidance on suitable tVNS approach for improving functional independence and quality of life for stroke survivors.
Read the detailed description
Stroke is characterized as a neurological deficit resulting from a sudden focal injury to central nervous system due to vascular issue by blockage and rupture of artery that leads to hypoxic injury and ultimately cell death. Stroke is primarily categories into two types: ischemic stroke that accounts for 85 % of cases and haemorrhagic stroke which make up 15%. Stroke leads to physical, cognitive, speech, perceptual and psychological Impairments. Post stroke impairments of the upper limb and lower limb leads to activity limitations in self-care and mobility and restricted participation in caring family and employment.
Multidisciplinary approach is used in stroke rehabilitation to create a rehabilitation program that aim to improve the function and improve the quality of life. Physical medicine and rehabilitation is focused on promoting recovery, improving or restoring functional abilities, anticipating potential long-term complications, and enhancing the quality of life for individuals with physical impairments or disabilities. Now a days there are many contemporary approaches used in rehabilitation like non-invasive brain simulation, robotics, gamification, virtual reality, CIMT, mirror therapy and many others, aimed to enhance the recovery after stroke.
Transcutaneous vagus nerve stimulation tVNS was developed two decades ago as a non-invasive, cost effective and easily applicable treatment option as compared to invasive vagus nerve stimulation for the treatment of epilepsy, cognitive impairments and stroke rehabilitation. Cutaneous innervation of vagus nerve is by two branches, one through auricular branch at external acoustic meatus, inner tragus, and the periauricular skin surrounding the cymba conchae and the other through cervical branch at anterior to sternocleidomastoid at the mid of neck. Several devices are used for stimulating the vagus nerve transcutaneously, as NEMOS that stimulates at the concha of outer ear, CE (European Conformity) and a hand held device Gammacore. On the other hand TENS-200 or Digitimer DS7A often require custom-made electrodes, also used in stimulation. In 2018 a systematic review was conducted on the safety of tVNS that results in transcutaneous vagus nerve stimulation (tVNS) is generally well tolerated in humans at the tested doses and is considered safe.
In parasympathetic nervous system vagus nerve is a major component that emerges from the medullae oblongata, passes through the jugular foramen to leave the cranial activity and travel downward between the neurovascular bundle situated between internal jugular vein and common carotid artery. It extends to thoracic and abdominal cavities and supply multiple organs and regulate autonomic nervous system. VNS play its role by stimulating the afferent and efferent fibers of the VN that primarily comprises the unmyelinated sensory afferent fibers, accounting for 80-90% of the nerve fiber, with the remaining 10-20% being myelinated efferent fibers. These fibers project upward to the brainstem nucleus and relay circuit, influencing the nucleus tractus solitarius (NTS) and locus coeruleus (LC). NTS projects different brain areas as amygdala, hippocampus, locus coeruleus and prefrontal cortex. The effects of direct VNS on enhancement of memory, motor learning and neuroplasticity also suggest a role for treatment of cognitive disorders, stroke, and other conditions. The cholinergic activity of the efferent branch of the vagus nerve has an immune inflammatory regulatory effect, which is referred to as the cholinergic anti-inflammatory pathway (CAP).
Upper limb impairment is a frequent outcome of stroke, greatly affecting a patient's quality of life. Recent research has shown that vagus nerve stimulation (VNS) combined with rehabilitation significantly enhances forelimb strength and movement speed in rat models of ischemic stroke. VNS is thought to amplify the advantages of rehabilitation by fostering neuroplasticity.
While the efficacy of taVNS in enhancing motor recovery post-stroke is well-documented, there is a paucity of comparative studies investigating the distinct effects of auricular and cervical tVNS on upper limb function, cognitive outcomes, and quality of life in subacute stroke patients. This gap necessitates further research to determine optimal stimulation modalities and their broader neurorehabilitation benefits
- Conditions
- Stroke, Stroke, Acute
- Being tested
- Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises, Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercises
- Keywords
- Task Specific Training, Upper Limb Function, Cognition
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercisesOther
Group A will receive application of TENS to stimulate the vagus nerve at the ear level, apply the clip electrodes at the targus/cymba concha and the other electrode anywhere in the skin over neck Mode on TENS will be normal, with the width pulse of 250µs. FITT will be as follow Frequency of 25 Hz, Intensity 1mA, Time 30 minutes and the treatment will be of 5 days a week for 8 consecutive weeks
- For grip and release: Use a soft ball, putty, or other textured objects. The patient squeezes the object to strengthen their grip and then releases it.
- Reaching task: Place objects at varying distances in front of the patient. Encourage them to reach out with the affected arm to grasp the items and then bring them back.
- Bilateral arm movement: Encourage simultaneous reaching or moving with both arms (e.g., pushing against a wall or lifting a lightweight object) to promote symmetry and coordination. Improve coordination and function of both arms.
- Tabletop activities: Engaging in activities lik
Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercisesOther
Group B will receive application of TENS to stimulate the vagus nerve at the neck level, apply the pad electrodes at the anterior mid to neck and the other electrode over back of neck Mode on TENS will be normal, with the width pulse of 250µs. FITT will be as follow Frequency of 25 Hz, Intensity 1mA, Time 30 minutes and the treatment will be of 5 days a week for 8 consecutive weeks
- For grip and release: Use a soft ball, putty, or other textured objects. The patient squeezes the object to strengthen their grip and then releases it.
- Reaching task: Place objects at varying distances in front of the patient. Encourage them to reach out with the affected arm to grasp the items and then bring them back.
- Bilateral arm movement: Encourage simultaneous reaching or moving with both arms (e.g., pushing against a wall or lifting a lightweight object) to promote symmetry and coordination. Improve coordination and function of both arms.
- Tabletop activities: Engaging in activities like sortin
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises | Experimental | Group A will receive application of TENS to stimulate the vagus nerve at the ear level, apply the clip electrodes at the targus/cymba concha and the other electrode anywhere in the skin over neck along with task specific exercises Receives: Other: Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises |
| Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercises | Active comparator | Group B will receive application of TENS to stimulate the vagus nerve at the neck level, apply the pad electrodes at the anterior mid to neck and the other electrode over back of neck along task specific exercises Receives: Other: Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-meyer assessment of upper limb (FMA-UE)
The Fugl-Meyer Assessment-Upper Extremity (FMA-UE) is a commonly utilized tool for measuring motor impairment in stroke rehabilitation. The FMA-UE has demonstrated excellent test-retest and inter- and intra-rater reliability, and evidence for its content validity in acute and subacute populations has been widely reported. The UE section of the FMA consists of 33 items and is scored on a 3-point ordinal scale with 0 meaning cannot perform, 1 meaning can partially perform, and 2 meaning can perform fully. Scores are summed with a maximum potential score of 66 points.
Measured: baseline, after 4 weeks, after 8 weeks
Montreal cognitive assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a one-page, 30-point cognitive screening measurement scale that takes about 10 minutes to administer. There are 12 subtasks in the MoCA test that include memory, visuospatial orientation, executive functioning, phonemic fluency, and two-item abstract thinking task, attention, concentration, and working memory, language, orientation to time and place. A score of 26 is a cutoff score to differentiate between normal and abnormal. These findings suggest that MoCA is a reliable and valid tool for detecting major neurocognitive disorders in older populations.
Measured: baseline, after 4 weeks, after 8 weeks
Wolf Motor Function Test (WMFT)
The Wolf Motor Function Test (WMFT) is a standardized assessment tool designed to evaluate upper extremity motor function in individuals who have suffered a stroke or other neurological impairments. It measures the ability to perform tasks that require reaching, grasping, and manipulating objects, focusing on both speed and quality of movement. It is a 21 items scale, ranging from simple movements to more complex actions, allowing for a comprehensive evaluation of motor skills. The items are rated on a 6-point scale, it took approximately 30 minutes.
Measured: baseline, after 4 weeks, after 8 weeks
Secondary outcomes (1)
Stroke-Specific Quality of Life Scale (SS-QOL)
The Stroke-Specific Quality of Life Scale (SS-QOL) is a comprehensive, self-report measure designed specifically to assess health-related quality of life in stroke survivors. The novel 17-item SS-QOL scale (SS-QOL-17) was constructed with the aim of providing a well-balanced measuring tool to depict QOL widely while ensuring the simplicity of administration. It consists of 17- items including mobility, energy, upper extremity function, work/productivity, mood, self-care, social roles, family roles, vision, language, thinking, and personality. Each item is rated on a 5-point Likert scale, with higher scores indicating better function. The total score ranges from 49 to 245, with domain scores calculated as the mean of item scores within each domain.
Measured: baseline, after 4 weeks, after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start20 Nov 2025
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Model description
- Interventional study model for this study is a parallel-group randomized clinical trial (RCT). This model involves two distinct groups: Treatment Group A Participants will receive transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises Treatment Group B Participants will receive transcutaneous vagus nerve stimulation through cevical branch along with task specific exercises Each participant is assigned randomly to one of these groups, ensuring that comparisons between the groups is unbiased. This parallel structure means each group undergoes its specific intervention throughout the study period without crossover to the other group's intervention. This approach helps assess the suitable tVNS approach for improving functional independence and quality of life for stroke survivors
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahore University of Biological and Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, Principal investigator, Lahore University of Biological and Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253870
- Sponsor's protocol ID
- UBAS/ERB/FoRS/25/O32 Wafa
- Status last verified
- Jun 2026
- First submitted
- 19 Nov 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hays SA, Rennaker RL, Kilgard MP. Targeting plasticity with vagus nerve stimulation to treat neurological disease. Prog Brain Res. 2013;207:275-99. doi: 10.1016/B978-0-444-63327-9.00010-2.
PubMed 24309259Hilz MJ. Transcutaneous vagus nerve stimulation - A brief introduction and overview. Auton Neurosci. 2022 Dec;243:103038. doi: 10.1016/j.autneu.2022.103038. Epub 2022 Sep 27.
PubMed 36201901Butt MF, Albusoda A, Farmer AD, Aziz Q. The anatomical basis for transcutaneous auricular vagus nerve stimulation. J Anat. 2020 Apr;236(4):588-611. doi: 10.1111/joa.13122. Epub 2019 Nov 19.
PubMed 31742681Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6.
PubMed 32837228
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Transcutaneous Auricular and Cervical Vagus Nerve Stimulation on Upper Limb Function, Cognition and Quality of Life in Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT07253870
- Acronym / sponsor ID
- UBAS/ERB/FoRS/25/O32 Wafa
- Conditions
- Stroke, Stroke, Acute
- Keywords
- Task Specific Training, Upper Limb Function, Cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 28 Nov 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.
This study aims to determine whether transcutaneous vagus nerve stimulation (tVNS) via auricular or cervical branches enhances recovery when combined with task-specific training in subacute stroke patients. We anticipate finding that both stimulation methods may improve upper limb motor function compared to conventional therapy. The research is expected to reveal specific cognitive domains (attention, memory, executive function) that benefit most from each stimulation approach, while also demonstrating meaningful improvements in patients' quality of life measures. These findings may make a significant practical contribution by providing clinicians with evidence-based guidance on suitable tVNS approach for improving functional independence and quality of life for stroke survivors.
Detailed description
Stroke is characterized as a neurological deficit resulting from a sudden focal injury to central nervous system due to vascular issue by blockage and rupture of artery that leads to hypoxic injury and ultimately cell death. Stroke is primarily categories into two types: ischemic stroke that accounts for 85 % of cases and haemorrhagic stroke which make up 15%. Stroke leads to physical, cognitive, speech, perceptual and psychological Impairments. Post stroke impairments of the upper limb and lower limb leads to activity limitations in self-care and mobility and restricted participation in caring family and employment.
Multidisciplinary approach is used in stroke rehabilitation to create a rehabilitation program that aim to improve the function and improve the quality of life. Physical medicine and rehabilitation is focused on promoting recovery, improving or restoring functional abilities, anticipating potential long-term complications, and enhancing the quality of life for individuals with physical impairments or disabilities. Now a days there are many contemporary approaches used in rehabilitation like non-invasive brain simulation, robotics, gamification, virtual reality, CIMT, mirror therapy and many others, aimed to enhance the recovery after stroke.
Transcutaneous vagus nerve stimulation tVNS was developed two decades ago as a non-invasive, cost effective and easily applicable treatment option as compared to invasive vagus nerve stimulation for the treatment of epilepsy, cognitive impairments and stroke rehabilitation. Cutaneous innervation of vagus nerve is by two branches, one through auricular branch at external acoustic meatus, inner tragus, and the periauricular skin surrounding the cymba conchae and the other through cervical branch at anterior to sternocleidomastoid at the mid of neck. Several devices are used for stimulating the vagus nerve transcutaneously, as NEMOS that stimulates at the concha of outer ear, CE (European Conformity) and a hand held device Gammacore. On the other hand TENS-200 or Digitimer DS7A often require custom-made electrodes, also used in stimulation. In 2018 a systematic review was conducted on the safety of tVNS that results in transcutaneous vagus nerve stimulation (tVNS) is generally well tolerated in humans at the tested doses and is considered safe.
In parasympathetic nervous system vagus nerve is a major component that emerges from the medullae oblongata, passes through the jugular foramen to leave the cranial activity and travel downward between the neurovascular bundle situated between internal jugular vein and common carotid artery. It extends to thoracic and abdominal cavities and supply multiple organs and regulate autonomic nervous system. VNS play its role by stimulating the afferent and efferent fibers of the VN that primarily comprises the unmyelinated sensory afferent fibers, accounting for 80-90% of the nerve fiber, with the remaining 10-20% being myelinated efferent fibers. These fibers project upward to the brainstem nucleus and relay circuit, influencing the nucleus tractus solitarius (NTS) and locus coeruleus (LC). NTS projects different brain areas as amygdala, hippocampus, locus coeruleus and prefrontal cortex. The effects of direct VNS on enhancement of memory, motor learning and neuroplasticity also suggest a role for treatment of cognitive disorders, stroke, and other conditions. The cholinergic activity of the efferent branch of the vagus nerve has an immune inflammatory regulatory effect, which is referred to as the cholinergic anti-inflammatory pathway (CAP).
Upper limb impairment is a frequent outcome of stroke, greatly affecting a patient's quality of life. Recent research has shown that vagus nerve stimulation (VNS) combined with rehabilitation significantly enhances forelimb strength and movement speed in rat models of ischemic stroke. VNS is thought to amplify the advantages of rehabilitation by fostering neuroplasticity.
While the efficacy of taVNS in enhancing motor recovery post-stroke is well-documented, there is a paucity of comparative studies investigating the distinct effects of auricular and cervical tVNS on upper limb function, cognitive outcomes, and quality of life in subacute stroke patients. This gap necessitates further research to determine optimal stimulation modalities and their broader neurorehabilitation benefits
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional study model for this study is a parallel-group randomized clinical trial (RCT). This model involves two distinct groups: Treatment Group A Participants will receive transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises Treatment Group B Participants will receive transcutaneous vagus nerve stimulation through cevical branch along with task specific exercises Each participant is assigned randomly to one of these groups, ensuring that comparisons between the groups is unbiased. This parallel structure means each group undergoes its specific intervention throughout the study period without crossover to the other group's intervention. This approach helps assess the suitable tVNS approach for improving functional independence and quality of life for stroke survivors
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises | Experimental | Other: Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercisesGroup A will receive application of TENS to stimulate the vagus nerve at the ear level, apply the clip electrodes at the targus/cymba concha and the other electrode anywhere in the skin over neck along with task specific exercises |
| Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercises | Active comparator | Other: Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercisesGroup B will receive application of TENS to stimulate the vagus nerve at the neck level, apply the pad electrodes at the anterior mid to neck and the other electrode over back of neck along task specific exercises |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First ever ischemic stroke
- Subacute phase of stroke 3-6 months post onset
- Fugl-Meyer Assessment-Upper Extremity (FMA-UE) scores ranged from 20 - 50
Key exclusion criteria (6 listed)
- Previous injury or surgical intervention of vagus nerve
- Patients with cardiac arrest and arrythmias
- Uncontrolled hypertension
- Apraxia
- Other neurologic or musculoskeletal diseases
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 |
|---|---|---|
| Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercisesGroup A will receive application of TENS to stimulate the vagus nerve at the ear level, apply the clip electrodes at the targus/cymba concha and the other electrode anywhere in the skin over neck Mode on TENS will be normal, with the width pulse of 250µs. FITT will be as follow Frequency of 25 Hz, Intensity 1mA, Time 30 minutes and the treatment will be of 5 days a week for 8 consecutive weeks * For grip and release: Use a soft ball, putty, or other textured objects. The patient squeezes the object to strengthen their grip and then releases it. * Reaching task: Place objects at varying distances in front of the patient. Encourage them to reach out with the affected arm to grasp the items and then bring them back. * Bilateral arm movement: Encourage simultaneous reaching or moving with both arms (e.g., pushing against a wall or lifting a lightweight object) to promote symmetry and coordination. Improve coordination and function of both arms. * Tabletop activities: Engaging in activities lik | Other | Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises |
| Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercisesGroup B will receive application of TENS to stimulate the vagus nerve at the neck level, apply the pad electrodes at the anterior mid to neck and the other electrode over back of neck Mode on TENS will be normal, with the width pulse of 250µs. FITT will be as follow Frequency of 25 Hz, Intensity 1mA, Time 30 minutes and the treatment will be of 5 days a week for 8 consecutive weeks * For grip and release: Use a soft ball, putty, or other textured objects. The patient squeezes the object to strengthen their grip and then releases it. * Reaching task: Place objects at varying distances in front of the patient. Encourage them to reach out with the affected arm to grasp the items and then bring them back. * Bilateral arm movement: Encourage simultaneous reaching or moving with both arms (e.g., pushing against a wall or lifting a lightweight object) to promote symmetry and coordination. Improve coordination and function of both arms. * Tabletop activities: Engaging in activities like sortin | Other | Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercises |
Primary outcome
Fugl-meyer assessment of upper limb (FMA-UE)
Time frame: baseline, after 4 weeks, after 8 weeks
The Fugl-Meyer Assessment-Upper Extremity (FMA-UE) is a commonly utilized tool for measuring motor impairment in stroke rehabilitation. The FMA-UE has demonstrated excellent test-retest and inter- and intra-rater reliability, and evidence for its content validity in acute and subacute populations has been widely reported. The UE section of the FMA consists of 33 items and is scored on a 3-point ordinal scale with 0 meaning cannot perform, 1 meaning can partially perform, and 2 meaning can perform fully. Scores are summed with a maximum potential score of 66 points.
Montreal cognitive assessment (MoCA)
Time frame: baseline, after 4 weeks, after 8 weeks
The Montreal Cognitive Assessment (MoCA) is a one-page, 30-point cognitive screening measurement scale that takes about 10 minutes to administer. There are 12 subtasks in the MoCA test that include memory, visuospatial orientation, executive functioning, phonemic fluency, and two-item abstract thinking task, attention, concentration, and working memory, language, orientation to time and place. A score of 26 is a cutoff score to differentiate between normal and abnormal. These findings suggest that MoCA is a reliable and valid tool for detecting major neurocognitive disorders in older populations.
Wolf Motor Function Test (WMFT)
Time frame: baseline, after 4 weeks, after 8 weeks
The Wolf Motor Function Test (WMFT) is a standardized assessment tool designed to evaluate upper extremity motor function in individuals who have suffered a stroke or other neurological impairments. It measures the ability to perform tasks that require reaching, grasping, and manipulating objects, focusing on both speed and quality of movement. It is a 21 items scale, ranging from simple movements to more complex actions, allowing for a comprehensive evaluation of motor skills. The items are rated on a 6-point scale, it took approximately 30 minutes.
1 secondary outcome
Stroke-Specific Quality of Life Scale (SS-QOL)
Time frame: baseline, after 4 weeks, after 8 weeks
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 18 Jun 2026.
- Background: PubMed 24309259Hays SA, Rennaker RL, Kilgard MP. Targeting plasticity with vagus nerve stimulation to treat neurological disease. Prog Brain Res. 2013;207:275-99. doi: 10.1016/B978-0-444-63327-9.00010-2.
- Background: PubMed 36201901Hilz MJ. Transcutaneous vagus nerve stimulation - A brief introduction and overview. Auton Neurosci. 2022 Dec;243:103038. doi: 10.1016/j.autneu.2022.103038. Epub 2022 Sep 27.
- Background: PubMed 31742681Butt MF, Albusoda A, Farmer AD, Aziz Q. The anatomical basis for transcutaneous auricular vagus nerve stimulation. J Anat. 2020 Apr;236(4):588-611. doi: 10.1111/joa.13122. Epub 2019 Nov 19.
- Background: PubMed 32837228Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6.
- Individual participant dataSharing planned: No
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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.
Aruba Saeed principal investigator
Lahore University of Biological and Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises and Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercises in people with Stroke and Stroke, Acute, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
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 3 inclusion and 6 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 18 Jun 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 Pakistan. 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. 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 Wafa Mansha, DPT (+92266303005, wafamalik583@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-meyer assessment of upper limb (FMA-UE) (time frame: baseline, after 4 weeks, after 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07253870, which also lists 4 linked publications.
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 18 Jun 2026.