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Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Stroke

NCT06895005 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-30

No results posted yet for this study

Summary

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.

Conditions

  • Motor Impairment
  • Motor Impairments
  • Stroke
  • Stroke; Sequelae
  • Stroke, Ischemic

Interventions

DEVICE

Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy

Transcutaneous auricular vagus nerve stimulation using INPULSE 3 times a week for six consecutive weeks. The stimulation parameters will be a frequency of 30Hz with a pulse width of 300 us and a stimulation time of 1.5 seconds for each respiratory cycle. The electrical current will be gradually increased to a maximum of 5 mA (0.25-mA increments) to allow adaptation to the stimulation until a comfortable tolerance level is achieved. Patients will receive physical rehabilitation therapy during stimulation, which will include reaching and grasping exercises, gross movements, turning objects, simulating specific tasks, inserting objects, opening and closing containers.

OTHER

sham stimulation + rehabilitation therapy

Patients will receive physical rehabilitation therapy during placebo stimulation (No electrical stimulation), including reaching and grasping exercises, gross movements, turning objects, simulating specific tasks, inserting objects, opening and closing containers.

Sponsors & Collaborators

  • Ministerio de Ciencia Tecnología e Innovación - Minciencias

    collaborator UNKNOWN

  • Fundación Cardiovascular de Colombia

    lead OTHER

Principal Investigators

  • Sandra M Sanabria, Bacteriologist, PhD · Fundación Cardiovascular de Colombia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-11-24
Completion
2025-12-24

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06895005 on ClinicalTrials.gov