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NCT06895005Not yet recruiting

Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Stroke

Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation on Upper Limb Motor Recovery After Stroke

Source: ClinicalTrials.gov · Last updated 30 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
19 Mar 2025
Start date
1 Apr 2025
Primary completion date
24 Nov 2025
Lead sponsor
Fundación Cardiovascular de Colombia
Diseases
Stroke
NCT number
NCT06895005

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 1 Apr 2025 to the primary completion date, 24 Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient receiving any therapy at study entry that would interfere with VNS (e.g., drugs that interfere with neurotransmitter mechanisms: anticholinergics, adrenergic blockers, etc.).
  • Prior injury to vagus nerve.
  • Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug.

Other illness

  • 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.
  • History of stroke
  • History of cardiac arrhythmia
  • History of severe head trauma, brain surgery, deep brain stimulation, or brain injuries of other etiologies.
  • Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent subject from meeting protocol timeline.

Other

  • Bradycardia (\< 50 bpm) or hypotension (\< 90/60 mmHg)
  • Significant pre-existing disability
  • Pregnant or planning on becoming pregnant or breastfeeding during the study period.
  • Subjects who are currently in another clinical trial or plan to do so during the study period.

Who the study is looking for

  • 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.
  • Ability to provide written informed consent.
  • Hemodynamically stable patients.
  • Patients residing in the metropolitan area of Bucaramanga.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Neurology Center of Excellence - Hospital Internacional de Colombia - Fundación cardiovascular de Colombia
Coordinator of this site? Confirm its status
PiedecuestaColombiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.