Effect of non-invasive vagus nerve stimulation at the ear on motor and cognitive impairments after a stroke
Descrizione riassuntiva dello studio
Stroke is a relatively common condition in older adults, which can lead to hemiplegia (= motor deficits) as well as disturbances in cognitive processes such as attention, memory, sensory perception, and action planning (= cognitive deficits). These deficits are typically treated with physiotherapy, occupational therapy, and neuropsychological training. There has already been research on humans regarding the treatment of motor and cognitive deficits after stroke using a method called vagus nerve stimulation at the ear. The vagus nerve runs from the brainstem through the neck and chest into the abdomen, but it also has connections to the brain. A skin branch of the vagus nerve is located in the area of the outer ear. This branch can be non-invasively electrically stimulated via an electrode placed in the ear area using a stimulator. These stimuli activate specific centers that are important for motor and cognitive functions. Previous studies on humans have shown that vagus nerve stimulation can lead to improvement in hemiplegia for some patients with stroke. We also know that vagus nerve stimulation can positively influence cognitive deficits in people without a stroke. However, in these previously completed studies, the effect of vagus nerve stimulation has not been sufficiently investigated at a relatively early stage, i.e., 15 – 30 days after the occurrence of the stroke. Furthermore, it is not known why certain individuals with stroke benefit from this therapy while others do not. There is also little known about the effect of vagus nerve stimulation at the ear on cognitive deficits after stroke. In this study, we investigate whether stimulation of the vagus nerve at the ear can improve motor and cognitive deficits after stroke when therapy begins at an early stage after the event.
(BASEC)
Intervento studiato
Electrical vagus nerve stimulation at the ear (the vagus nerve sends a sensory skin branch to the outer ear). An electrode is placed in the area of the outer ear (similar to a headphone), through which weak electrical impulses are delivered. These impulses continue along the vagus nerve to the brain, where they enhance regenerative processes after stroke. These processes, in turn, promote improvement up to the restoration of motor and cognitive deficits.
(BASEC)
Malattie studiate
Investigated disease: Ischemic stroke, health status: motor and cognitive deficits due to an ischemic stroke
(BASEC)
- Onset of stroke ≥15 days and ≤30 days after randomization - National Institutes of Health (NIH) Stroke Scale Score: ≥ 3 points - Montreal Cognitive Assessment (MoCA) Score ≤ 26 points (BASEC)
Criteri di esclusione
- Age < 18 years - Active implants (e.g., pacemakers, deep brain stimulators, cochlear implants) - Pre-existing hemiplegia and dementia (BASEC)
Luogo dello studio
Altro
(BASEC)
Walzenhausen
(BASEC)
Sponsor
non disponibile
Contatto per ulteriori informazioni sullo studio
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Ethikkommission Ostschweiz EKOS
(BASEC)
Data di approvazione del comitato etico
27.02.2025
(BASEC)
ID di studio ICTRP
NCT06822140 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
non disponibile
Titolo accademico
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Motor and Cognitive Deficits After Ischemic Stroke (ICTRP)
Titolo pubblico
Effect of Vagus Nerve Stimulation Via the Outer Ear on Motor and Cognitive Deficits After Ischemic Stroke (ICTRP)
Malattie studiate
Ischemic StrokeMotor DeficitsCognitive ImpairmentVagus Nerve Stimulation (ICTRP)
Intervento studiato
Device: transcutaneous auricular vagus nerve stimulationDevice: sham-stimulation (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- 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
- First ever stroke
- Right-handed
- Ability to participate in a standardized rehabilitation therapy
- Written informed consent signed by the subject or next kin
Exclusion Criteria:
- 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)
- Pre-existing hemiparesis
- Documented history of dementia before index stroke
- Primary intracranial hematoma or subarachnoid hemorrhage
- Active implantable medical device (e.g., pacemaker, deep brain stimulator, cochlear
implants, cerebral shunts)
- Metal cervical spine hardware or metallic implant near the stimulation site
- Modified Rankin scale (mRS) = 2 prior to stroke onset
- Low heart rate (< 60 bpm)
- Severe vision and hearing problems
- Alcohol and drug abuse
- Active post-stroke delirium, unable to cooperate
- Type 1 and 2 diabetes mellitus
- Sore and diseased skin of the auricle
- Patients receiving any therapy (medication or otherwise) at study entry that would
interfere with VNS (ICTRP)
non disponibile
Endpoint primari e secondari
Fugl-Meyer-Motor-Assessment (ICTRP)
Consortium to Establish a Registry of Alzheimer's Disease (CERAD);Montreal Cognitive Assessment (MoCA);Wechsler Adult Intelligence Scales (WAIS-IV) working memory subtests;Digit Symbol Test;Stroop Color and Word Test;Self-Report Measure for the Assessment of Emotion Regulation Skills (SEK-27);Emotion Regulation Questionnaire (ERQ);Fatigue Scale for Motor and Cognitive Functions (FSMC);Pittsburgh Sleep Quality Index (PSQI);Stroke-Specific Quality of Life Scale (SS-QOL);Test of Attentional Performance (TAP);Action Research Arm Test (ARAT);National Institutes of Health Stroke Scale (NIHSS) score;Modified Rankin Scale (mRS);Functional Independence Measure (FIM) (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Felix Fluri, PD Dr. med.Felix Fluri, PD Dr. med., felix.fluri@kliniken-valens.chfelix.fluri@gmx.ch, +41 58 511 70 01+41 58 511 70 01 (ICTRP)
ID secondari
2024-D0114 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06822140 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile