Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFundación Cardiovascular de Colombia
About this trial
This study will evaluate the effects of transcutaneous vagus nerve stimulation in combination with physical rehabilitation on upper limb motor function of patients with stroke.
Eligibility criteria
Qualifiers
Age >18 years and <75 years
Unilateral supratentorial ischemic stroke that occurred at least 7 days but not more 30 days before enrollment.
Modified Rankin Scale between 0 and 1 before stroke
Contralesional UL motor impairment defined by NIHSS item 5 score ≥ 1 to ≤ 3.
Disqualifiers
Significant cognitive or language impairment that would interfere with study participation or informed consent. This criterion will be defined by NIHSS item 1a-c score > 2, item 9 score > 1, item 11 score = 2.
Medical conditions that could interfere with study participation, for example ear infections or skin wounds.
Bradycardia (< 50 bpm) or hypotension (< 90/60 mmHg)
Significant pre-existing disability
Trial design
Treatments tested in this trial
- Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy
- sham stimulation + rehabilitation therapy
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fundación Cardiovascular de Colombia
Lead sponsor
Ministerio de Ciencia Tecnología e Innovación - Minciencias
Collaborator
Source ClinicalTrials.gov