Effect of Vagus Nerve Stimulation Via the Outer Ear on Motor and Cognitive Deficits After Ischemic Stroke

NCT06822140 | Not Yet Recruiting

• 1 other identifier: 2024-D0114
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke; Motor Deficits; Cognitive Impairment; Vagus Nerve Stimulation

Outcome Measures

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.

  Assessed <7 days and 6 weeks after admission at the Rheinburg Klinik.

Secondary Outcomes (15)

• Consortium to Establish a Registry of Alzheimer's Disease (CERAD)

  Assessed < 7 days and 6 weeks after admission to the Rheinburg Klinik.

• Montreal Cognitive Assessment (MoCA)

  Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.

• Wechsler Adult Intelligence Scales (WAIS-IV) working memory subtests

  Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.

• Digit Symbol Test

  Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.

• Stroop Color and Word Test

  Assessed < 7 days and after 6 weeks after admission to the Rheinburg Klinik.

Study Arms (2)

VNS group

EXPERIMENTAL

Device: transcutaneous auricular vagus nerve stimulation

control group

SHAM COMPARATOR

Device: sham-stimulation

Interventions

transcutaneous auricular vagus nerve stimulation DEVICE

Stimulation 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.

VNS group

sham-stimulation DEVICE

An electrode is only attached to the ear without applying electrical impulses.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rheinburg-Klinik: lead

Study Sites (1)

Rheinburg Klinik

Walzenenhausen, 9824, Switzerland

Location

MeSH Terms

Conditions

Ischemic Stroke; Neurologic Manifestations; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Felix Fluri, PD Dr. med.

CONTACT

+41 58 511 70 01; felix.fluri@kliniken-valens.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 12, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CH (1)