Effect of Vagus Nerve Stimulation Via the Outer Ear on Motor and Cognitive Deficits After Ischemic Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRheinburg-Klinik
About this trial
The goal of this clinical trial is to learn if transcutaneous auricular vagus nerve stimulation (taVNS) works to treat motor and neurocognitive deficits after ischemic stroke when applied within 30 days after onset of stroke.
The main questions it aims to answer are:
* Does tVNS improve motor deficits measured by the Fugl-Mayer assessment after ischemic stroke? * Does tVNS ameliorate stroke-related cognitive impairment? Researchers will compare tVNS to a placebo (sham stimulation, i.e. an electrode is fixed on the ear without applying electrical impulses ) to see if tVNS works to treat motor and cognitive deficits after stroke .
Participants will:
* Receive tVNS or sham stimulation for 30 minutes 5 days a week during 5 weeks after ischemic stroke * Receive smotor and cognitive training during the tVNS or sham stimulation * Will take part on a standardized stroke rehabilitation program during the 5 weeks in a rehabilitation clinic.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Onset of stroke ≥15 days and ≤30 days after randomization
Ischemic stroke in the anterior cerebral circulation detected by MR imaging or computer tomography
National Institutes of Health Stroke Scale (NIHSS) score ≥3 points
Montreal Cognitive Assessment (MoCA) score ≤ 26 points
Disqualifiers
Age < 18 years
Pregnant and breastfeeding women
Severe concomitant neurological (brain tumor, encephalitis, Parkinson disease, epilepsy prior to stroke onset) or mental disorders (psychiatric conditions such as schizophrenia, uncontrolled depression or bipolar disorder before stroke onset)
Severe aphasia (i.e. unable to follow two-stage-commands)
Trial design
Design model
Parallel
Treatments tested in this trial
transcutaneous auricular vagus nerve stimulation
DeviceStimulation parameters: * Stimulating side: ipsilateral to the infarcted brain hemisphere * Location of pStimulation: Cymba conchae * Impulse shape: bi-phasic * Impulse intensity: at least 0.5 mA (max. 2.0 mA). * Impulse duration: 28 sec on, 32 sec off * Impulse frequency: 20-30 Hz.
sham-stimulation
DeviceAn electrode is only attached to the ear without applying electrical impulses.
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: VNS groupExperimental treatment 1 intervention
Group B: control groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fugl-Meyer-Motor-Assessment
FMMA is a stroke-specific performance-based index of impairment. It has been designed to assess motor functioning, sensation, balance, joint range of motion and joint pain score in stroke survivors. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0 means "cannot perform"; 1 is "performs partially"; and 2 stands for "performs fully". In the present study, we will focus on the motor function score. It ranges from 0 (hemiplegia) to 100 points (normal motor function) and is divided into 66 points for the upper extremity and 34 points for the lower extremity. A difference of 5.25 points for the upper extremity and 6 points for the lower extremity are reported as minimal clinically important difference for the FMA.
Time frame
Assessed <7 days and 6 weeks after admission at the Rheinburg Klinik.Secondary outcomes
1
Consortium to Establish a Registry of Alzheimer's Disease (CERAD)
The CERAD neuropsychological test battery: includes 7 standardized subtests providing a comprehensive overview of a patient's cognitive performance. It is a proven tool in clinical practice and takes about 45 minutes to complete. The subtests are: * Semantic Fluency (Animals) * Boston Naming Test (BNT) * Learning and Memory Test * Constructional Praxis * Trail Making Tests (TMT) A and B * Phonemic Fluency (S-Words) The raw score is converted into standard scores (Z-scores), with Z-scores of -1 or lower considered indicative of cognitive impairment.
Time frame
Assessed < 7 days and 6 weeks after admission to the Rheinburg Klinik.2
Montreal Cognitive Assessment (MoCA)
The MoCA is a cognitive screening tool that requires the patient to complete 11 tasks assessing attention/concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The test takes approximately 10 minutes to administer with a maximum score of 30 points. Higher scores indicate better cognitive performance, a score of 26 or above is considered normal
Time frame
Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.3
Wechsler Adult Intelligence Scales (WAIS-IV) working memory subtests
The WAIS-IV consists of different subtests and scales to measure intelligence in subjects aged 16 or older. The working memory subtests are used to assess short-term auditory memory and working memory. In the first test, participants are presented a sequence of numbers and asked to repeat them in the same order. In the "backward" condition, participants are asked to repeat the presented numbers in the reverse order. The first subtest measures short-term memory and attention, the second subtests is an indicator for working memory capacity and the ability to mentally manipulate information. The raw score is transformed into scaled scores, with values below 7 indicating a lower level of intelligence.
Time frame
Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.4
Digit Symbol Test
The Digit Symbol Test is a well-established psychometric test paradigm which is used to measure general cognitive performance. Participants are asked to match numbers with corresponding symbols based on a key provided under time constraints. Number of correct matches are analyzed and are a measure of complex attention, working memory and associative learning. The Digit Symbol test is a widely used validated neuropsychological instrument that takes participants around 1-2 minutes to complete.
Time frame
Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Rheinburg Klinik Status unavailable 9824, Walzenenhausen
Switzerland
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Source ClinicalTrials.gov
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