Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Stroke

NCT06895005 | Not Yet Recruiting

• 1 other identifier: CEI-2021-03209
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Stroke; Vagus nerve; Vagus nerve stimulation; Transcutaneous vagus nerve stimulation; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  1 day and 30 days after the end of the intervention

• 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.

  1 day and 30 days after the end of the intervention

Secondary Outcomes (2)

• Hospital anxiety and depression

  1 day and 30 days after the end of the intervention

• Medical device safety

  During the intervention period.

Study Arms (2)

Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy

EXPERIMENTAL

Device: Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy

Sham stimulation + rehabilitation therapy

SHAM COMPARATOR

Other: sham stimulation + rehabilitation therapy

Interventions

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.

Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy

sham stimulation + rehabilitation therapy OTHER

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.

Sham stimulation + rehabilitation therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Cardiovascular de Colombia: lead
• Ministerio de Ciencia Tecnología e Innovación - Minciencias: collaborator

Study Sites (1)

Neurology Center of Excellence - Hospital Internacional de Colombia - Fundación cardiovascular de Colombia

Piedecuesta, Santander Department, Colombia

Location

Related Publications (9)

• Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016/S0140-6736(21)00475-X.

  PMID: 33894832 BACKGROUND

• Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part II. Headache. 2016 Feb;56(2):259-66. doi: 10.1111/head.12650. Epub 2015 Sep 18.

  PMID: 26381725 BACKGROUND

• Yap JYY, Keatch C, Lambert E, Woods W, Stoddart PR, Kameneva T. Critical Review of Transcutaneous Vagus Nerve Stimulation: Challenges for Translation to Clinical Practice. Front Neurosci. 2020 Apr 28;14:284. doi: 10.3389/fnins.2020.00284. eCollection 2020.

  PMID: 32410932 BACKGROUND

• van der Meij A, Wermer MJH. Vagus nerve stimulation: a potential new treatment for ischaemic stroke. Lancet. 2021 Apr 24;397(10284):1520-1521. doi: 10.1016/S0140-6736(21)00667-X. No abstract available.

  PMID: 33894818 BACKGROUND

• Kong KH, Chua KS, Lee J. Recovery of upper limb dexterity in patients more than 1 year after stroke: Frequency, clinical correlates and predictors. NeuroRehabilitation. 2011;28(2):105-11. doi: 10.3233/NRE-2011-0639.

  PMID: 21447911 BACKGROUND

• Dancause N, Nudo RJ. Shaping plasticity to enhance recovery after injury. Prog Brain Res. 2011;192:273-95. doi: 10.1016/B978-0-444-53355-5.00015-4.

  PMID: 21763529 BACKGROUND

• Cramer SC. Repairing the human brain after stroke: I. Mechanisms of spontaneous recovery. Ann Neurol. 2008 Mar;63(3):272-87. doi: 10.1002/ana.21393.

  PMID: 18383072 BACKGROUND

• Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS. Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1994 Apr;75(4):394-8. doi: 10.1016/0003-9993(94)90161-9.

  PMID: 8172497 BACKGROUND

• Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.

  PMID: 23652265 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sandra M Sanabria, Bacteriologist, PhD

  Fundación Cardiovascular de Colombia

  STUDY DIRECTOR

Central Study Contacts

Nicolas Peña Novoa, Physiotherapist

CONTACT

(+57) 3008682154; nicolasnovoa2000@gmail.com

Sandra M Sanabria, Bacteriologist, PhD

CONTACT

sandrasanabria@fcv.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A double blinding will be performed. This information will be guaranteed to remain masked until after the analysis is performed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: April 1, 2025
• Primary Completion: November 24, 2025
• Study Completion: December 24, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

CO (1)