Transcutaneous Auricular Vagus Nerve Stimulation in Patients with Stroke (INPULSE)

March 25, 2025 updated by: Fundación Cardiovascular de Colombia

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke is a neurological condition caused by vascular problems such as cerebral infarction and/or intracerebral or subarachnoid hemorrhage(1). In 2019, more than 12 million strokes occurred worldwide, making it one of the leading causes of morbidity.

Motor impairment is considered one of the main problems resulting from this condition(2). Recovery of motor function occurs spontaneously during the first months after stroke(3) as a result of brain plasticity processes in the sensory and motor systems(4). It is estimated that 50 to 75% of patients with stroke persist with significant motor sequelae limiting daily activities(5).

Recently, Vagus Nerve Stimulation (VNS) has been proposed as an intervention that could have beneficial effects in the recovery of motor function in these patients, since it contributes to the generation of adaptive neuroplasticity and the activation of neuromodulators that reduce brain inflammation(6).

VNS has mainly been administered by using implanted electrodes, but more recently, a non-invasive technique, known as transcutaneous VNS (cervical or auricular) has been proposed. VNS has traditionally required the implantation of an electrical pulse generator at the left subclavicular level, which is connected to electrodes in the left cervical branch of the vagus nerve(7). Its insertion is performed by a surgical procedure, which presents a higher risk of adverse events(8), the most frequent being dysphonia during stimulation, due to its proximity to the laryngeal nerve(9). On the other hand, transcutaneous VNS works through the placement of non-invasive electrodes on the neck or auricle for stimulation of the cervical or auricular branch of the vagus nerve respectively(7). Transcutaneous VNS has a lower risk of adverse events, is reversible and easy to implement(7). In addition, experimental evidence suggests that the effects of transcutaneous VNS on brain function are comparable to those obtained with VNS(8).

This study will evaluate the effects of transcutaneous vagus nerve stimulation (tVNS) in combination with physical rehabilitation on upper limb motor function of patients with stroke. Thirty patients with ischemic stroke will be included in the study. Subjects will be randomized to tVNS + physical rehabilitation or sham stimulation + physical rehabilitation. Therapy sessions will be performed 3 times a week for six consecutive weeks. Efficacy will be evaluated by assessing the change in motor function of the upper limb, the next day and 30 days after the end of the intervention. The motor function of the upper limb will be assessed by means of the Fugl-Meyer scale score.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Colombia
    • Santander
      • Piedecuesta, Santander, Colombia
        • Neurology Center of Excellence - Hospital Internacional de Colombia - Fundación cardiovascular de Colombia
        • Contact:
        • Contact:
          • Tony F Álvarez, MD - Neurologist
        • Contact:
          • Ronald G Gómez, MD, MSc, PhD
        • Contact:
          • Jorge A Ramos, Nurse, MSc, PhD
        • Contact:
          • Sandra M Sanabria, Bacteriologist - PhD
        • Contact:
          • Ligia C Rueda, MD - Psychiatrist
        • Contact:
          • Federico A Silva, MD - Neurologist, MSc
        • Contact:
          • Edwin O González, Electronic Engineer
        • Contact:
          • Nicolas Peña, Phisiotherapist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • History of stroke
  • History of cardiac arrhythmia
  • History of severe head trauma, brain surgery, deep brain stimulation, or brain injuries of other etiologies.
  • Pregnant or planning on becoming pregnant or breastfeeding during the study period.
  • Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent subject from meeting protocol timeline.
  • Subjects who are currently in another clinical trial or plan to do so during the study period.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy
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.
Sham Comparator: Sham stimulation + rehabilitation therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor function of the upper limb
Time Frame: 1 day and 30 days after the end of the intervention
Efficacy will be assessed by evaluating the change in motor function of the upper limb, the next day and 30 days after the end of the intervention. The motor function of the upper limb will be assessed by means of the Fugl-Meyer scale score. The motor function component ranges from 0 to 100, where higher scores indicate better motor recovery.
1 day and 30 days after the end of the intervention
Arm and hand mobility Description:
Time Frame: 1 day and 30 days after the end of the intervention
Change in arm mobility the next day and 30 days after the end of the intervention. Arm and hand mobility will be assessed by the ARAT test. The maximum score on the ARAT is 57 points ( 0 to 57). A higher score indicates better arm function.
1 day and 30 days after the end of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital anxiety and depression
Time Frame: 1 day and 30 days after the end of the intervention
Change in anxiety and depression symptoms the next day and 30 days after the end of the intervention. The anxiety and depression symptoms will be assessed by means of the HADS scale score. Each subscale score ranges from 0 to 21, and higher scores indicate more severe anxiety and/or depressive symptoms.
1 day and 30 days after the end of the intervention
Medical device safety
Time Frame: During the intervention period.
Adverse events associated with the stimulation, device and health attention are associated. It would be a measure of the number of events related or not related to the device. Each adverse event should be asses by ethical committee and medical team.
During the intervention period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Cardiovascular de Colombia

Collaborators

Ministerio de Ciencia Tecnología e Innovación - Minciencias

Investigators

  • Study Director: Sandra M Sanabria, Bacteriologist, PhD, Fundacion Cardiovascular de Colombia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

November 24, 2025

Study Completion (Estimated)

December 24, 2025

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI-2021-03209

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe