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Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Stroke

ConditionsMotor ImpairmentMotor ImpairmentsStrokeStroke; SequelaeStroke, Ischemic
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy

    Device

    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 stimulation + rehabilitation therapy

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Transcutaneous auricular vagus nerve stimulation + rehabilitation therapyExperimental treatment 1 intervention
Group B: Sham stimulation + rehabilitation therapySham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Motor function of the upper limb

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.

Time frame
1 day and 30 days after the end of the intervention
2

Arm and hand mobility Description:

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.

Time frame
1 day and 30 days after the end of the intervention

Secondary outcomes

1

Hospital anxiety and depression

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.

Time frame
1 day and 30 days after the end of the intervention
2

Medical device safety

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.

Time frame
During the intervention period.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación Cardiovascular de Colombia

Lead sponsor

Ministerio de Ciencia Tecnología e Innovación - Minciencias

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: