Comperative Effects of Transcutaneous Auricular and Cervical Vagus Nerve Stimulation in Subacute Stroke Patients
Comparative Effects of Transcutaneous Auricular and Cervical Vagus Nerve Stimulation on Upper Limb Function, Cognition and Quality of Life in Subacute Stroke Patients
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wafa Mansha, DPT
- Phone Number: +92266303005
- Email: wafamalik583@gmail.com
Study Contact Backup
- Name: Aruba Saeed, PhD
- Phone Number: +923344399403
- Email: arubasaeedpt@gmail.com
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54660
- Recruiting
- Shadman Medical Center, Stroke Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises
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
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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
|
|
Active Comparator: Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercises
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline, after 4 weeks, after 8 weeks
|
|
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.
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baseline, after 4 weeks, after 8 weeks
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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.
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baseline, after 4 weeks, after 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stroke-Specific Quality of Life Scale (SS-QOL)
Time Frame: baseline, after 4 weeks, after 8 weeks
|
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.
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baseline, after 4 weeks, after 8 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Aruba Saeed, Lahore University of Biological and Applied Sciences
Publications and helpful links
General 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.
- Hilz 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.
- Murphy 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.
- Butt 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBAS/ERB/FoRS/25/O32 Wafa
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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