Vagus Nerve Stimulation for Stroke

(StrokeVNS Trial)

Overseen By Niko Fullmer, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Casa Colina Hospital and Centers for Healthcare

Disqualifiers: Advanced cardiac, pulmonary, liver, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 2 weeks

22 Participants Needed

Trial Summary

What is the purpose of this trial?

In the United States, more than 795,000 people have a stroke every year. Motor impairment after a stroke is common and can be debilitating. To date, there remain few treatments available to help improve motor recovery after a stroke, making this an important area of research. Novel use of neuromodulation such as Invasive Vagus Nerve Stimulation (VNS) has been shown to improve motor recovery in stroke patients. Vagus nerve stimulation (VNS), in which the nerve is stimulated with electrical pulses, has demonstrated success for a variety of conditions, including inflammation, depression, cognitive dysfunction, chronic fatigue, headaches/migraines, pain, insomnia, and cardiovascular issues. Very recently, non-invasive options have been developed and might be a promising alternative. The research in this area is still very limited and much more research is needed to investigate non-invasive/trancutaneous auricular vagus nerve stimulation (taVNS) related biomechanisms and to further support its efficacy in acute patients. The purpose of this study is to build upon the current research to investigate changes in electrical brain activity (using electrophysiology) related to improvements in both motor and cognitive recovery following the use of taVNS in acute stroke patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Transcutaneous auricular vagus nerve stimulation (taVNS) for stroke recovery?

Research shows that taVNS, when combined with conventional rehabilitation, can significantly improve motor and sensory functions in stroke patients without obvious side effects. Studies also suggest that taVNS may help reduce brain damage and promote recovery by activating similar pathways as invasive VNS, but without the need for surgery. ^{1 2 3 4 5}

How is transcutaneous vagus nerve stimulation (tVNS) different from other stroke treatments?

Transcutaneous vagus nerve stimulation (tVNS) is unique because it is a non-invasive treatment that stimulates the vagus nerve through the skin of the ear, unlike traditional surgical methods. It is combined with conventional rehabilitation to improve motor and sensory functions in stroke patients, offering a safe and portable option without the need for surgery. ^{1 2 3 5 6}

Research Team

Elliott Block, MD

Principal Investigator

Casa Colina Hospital and Centers for Healthcare

Eligibility Criteria

This trial is for individuals who have had their first stroke within the past month, whether it was ischemic (caused by a blood clot) or hemorrhagic (due to bleeding). It's not suitable for those who've had multiple strokes or other conditions that might interfere with the study.

Inclusion Criteria

My injury occurred within the last month.

I have had a stroke for the first time.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive taVNS for 45 minutes a day for 10 working days (5 days a week for 2 weeks) while hospitalized

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments conducted over the phone

6 months

1 visit (phone)

Treatment Details

Interventions

• Transcutaneous vagus nerve stimulation

Trial Overview The study is testing transcutaneous vagus nerve stimulation (taVNS), a non-invasive treatment that stimulates the vagus nerve through the skin. Researchers want to see if taVNS can improve motor and cognitive recovery after a stroke by observing changes in brain activity.

Participant Groups

Group I: TaVNS intervention Experimental Treatment 1 Intervention

Before starting applying taVNS, patients will be assessed using the FMA-U and the mRS for motor recovery as well as the MOCA for cognitive recovery. Resting state EEG will be recorded with eyes open during 15 minutes using our 64 electrodes cap (actiCHamp Plus; brainproducts.com), just after the behavioral assessment is performed. On the same day, patients will receive taVNS for 45 minutes, during therapy. The stimulation parameters, will be as follows: 250ms square pulses at 20 Hz. The electrical stimulation will given for 45 minutes a day for 10 working days (5 days a week for 2 weeks). The amplitude will be 1.7mA but may be reduced to 1.0mA if the patient is unable to tolerate due to discomfort or pain. After the last taVNS session is applied, outcome measures will be administered again by the research team. A follow-up at 6 months after the end of the last session will be conducted over the phone using the adapted version of the mRS and the MOCA.

Who Is Running the Clinical Trial?

Casa Colina Hospital and Centers for Healthcare

Lead Sponsor

Trials

11

Recruited

350+

Foundation for Physical Medicine and Rehabilitation

Collaborator

Trials

7

Recruited

240+

Findings from Research

Transcutaneous auricular vagus nerve stimulation (taVNS) significantly improved upper limb motor function in 21 subacute ischemic stroke patients compared to a sham treatment, as measured by the Fugl-Meyer assessment and other functional tests after 15 days of intervention.

The study found taVNS to be safe, with only one reported case of skin redness, indicating it may be a beneficial and low-risk option for enhancing recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Recovery of Upper Limb Motor Function in Subacute Ischemic Stroke Patients: A Randomized Pilot Study. Wu, D., Ma, J., Zhang, L., et al.[2021]

In a double-blinded randomized controlled trial with 60 acute stroke patients, transcutaneous auricular vagus nerve stimulation (ta-VNS) combined with conventional rehabilitation significantly improved recovery of motor, sensory, and emotional functions compared to sham treatment.

The study found no significant side effects from ta-VNS, indicating that it is a safe and effective noninvasive treatment option for patients recovering from acute ischemic or hemorrhagic strokes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of transcutaneous auricular vagus nerve stimulation combined with conventional rehabilitation training in acute stroke patients: a randomized controlled trial conducted for 1 year involving 60 patients. Li, JN., Xie, CC., Li, CQ., et al.[2022]

Transcutaneous vagus nerve stimulation (tVNS) has shown potential in reducing infarct size in animal models of hyperacute stroke and enhancing neurological recovery in chronic stroke when paired with limb movements.

The review emphasizes the need for further research to better understand the mechanisms of tVNS and to effectively translate its benefits into clinical practice for both acute and chronic stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

tVNS in Stroke: A Narrative Review on the Current State and the Future. Baig, SS., Kamarova, M., Bell, SM., et al.[2023]

Non-invasive transcutaneous vagus nerve stimulation (tVNS) has shown promise in improving neurological recovery after stroke, potentially reducing infarct size and enhancing motor function through mechanisms like anti-inflammatory effects and neuroplasticity.

Pilot clinical trials suggest that auricular tVNS, when combined with rehabilitation, may significantly improve upper limb motor and sensory functions in chronic stroke patients, indicating its potential as a viable alternative to invasive vagus nerve stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous vagus nerve stimulation (tVNS) in stroke: the evidence, challenges and future directions. Baig, SS., Kamarova, M., Ali, A., et al.[2022]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive and cost-effective method for modulating the vagus nerve, making it a promising alternative to traditional surgical vagus nerve stimulation.

taVNS allows for easy and safe administration, with considerations for proper electrode placement and individual dosing based on perception thresholds, which enhances its potential for treating various central and peripheral diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. Badran, BW., Yu, AB., Adair, D., et al.[2020]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a promising non-invasive treatment that can effectively improve motor function in patients who have experienced a stroke.

This review highlights the importance of stimulation parameters and timing, as well as the development of new devices, to enhance the application of taVNS in rehabilitating upper limb motor dysfunction after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Research Progress of the Post-Stroke Upper Limb Motor Function Improvement via Transcutaneous Auricular Vagus Nerve Stimulation. Shi, X., Zhao, J., Xu, S., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Recovery of Upper Limb Motor Function in Subacute Ischemic Stroke Patients: A Randomized Pilot Study. [2021]

2. India pubmed.ncbi.nlm.nih.gov

Efficacy and safety of transcutaneous auricular vagus nerve stimulation combined with conventional rehabilitation training in acute stroke patients: a randomized controlled trial conducted for 1 year involving 60 patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

tVNS in Stroke: A Narrative Review on the Current State and the Future. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Transcutaneous vagus nerve stimulation (tVNS) in stroke: the evidence, challenges and future directions. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical Research Progress of the Post-Stroke Upper Limb Motor Function Improvement via Transcutaneous Auricular Vagus Nerve Stimulation. [2023]