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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new method to aid stroke recovery using transcutaneous vagus nerve stimulation (taVNS). This technique sends tiny electrical pulses to a nerve in the ear, potentially improving movement and cognitive skills. The study seeks participants who experienced their first stroke within the past month. Those who recently had a stroke and are interested in new treatment options might find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research and potentially benefit from innovative treatment.

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 prior data suggests that transcutaneous vagus nerve stimulation is safe for stroke patients?

Research shows that using a device on the skin to stimulate the vagus nerve, known as transcutaneous vagus nerve stimulation (taVNS), is generally safe. Studies have found it usually causes only mild and short-lasting side effects. For instance, some people might feel slight discomfort or pain, but these sensations don't last long. In other studies, no major side effects were reported when taVNS was used alongside regular stroke rehabilitation, suggesting that most people tolerate the treatment well. Overall, evidence indicates that taVNS could be a promising method to aid stroke recovery without causing serious harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for stroke, which often includes physical rehabilitation and medications to prevent future strokes, transcutaneous vagus nerve stimulation (taVNS) offers a novel approach by directly targeting the nervous system. This technique involves stimulating the vagus nerve through the skin, potentially enhancing both motor and cognitive recovery after a stroke. Researchers are excited because this method could lead to faster and more comprehensive recovery by promoting brain plasticity and improving neural connections, offering hope for improved outcomes in stroke patients.

What evidence suggests that transcutaneous vagus nerve stimulation is effective for motor and cognitive recovery after a stroke?

Research shows that transcutaneous vagus nerve stimulation (tVNS), the treatment participants in this trial will receive, may aid stroke recovery. Studies have found that tVNS can enhance brain function and movement in stroke patients. For example, one study found it helps people regain arm movement after a stroke. Animal research also suggests that early use of tVNS can reduce the size of brain damage. Overall, the early results are promising, but further research is needed to confirm its benefits. ^{1 3 5 6 7}

Who Is on the Research Team?

Elliott Block, MD

Principal Investigator

Casa Colina Hospital and Centers for Healthcare

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38452937/

Transcutaneous auricular vagus nerve stimulation for post- ... Conclusions: The synergistic approach of combining ta-VNS with conventional treatment has demonstrated remarkable efficacy and tolerability in ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1566070221001399

Transcutaneous vagus nerve stimulation (tVNS) in stroke Transcutaneous vagus nerve stimulation (tVNS) has been shown to improve neurological outcomes in pre-clinical models of stroke and in early clinical studies of ...

3. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.043414

tVNS in Stroke: A Narrative Review on the Current State ... Transcutaneous vagus nerve stimulation (tVNS) has shown promising evidence as a tool to reduce infarct size in animal models of hyperacute stroke.

4. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1297887/full

Transcutaneous auricular vagus nerve stimulation on ... Vagus nerve stimulation delivered during motor rehabilitation improves recovery in a rat model of stroke. Neurorehabil. Neural Repair 28 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32802039/

Effect and Safety of Transcutaneous Auricular Vagus Nerve ... This study revealed that taVNS appeared to be beneficial to the recovery of upper limb motor function in subacute ischemia stroke patients ...

6. nature.com nature.com/articles/s41598-022-25864-1

Safety of transcutaneous auricular vagus nerve stimulation ... Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet ...

7. journals.lww.com journals.lww.com/nrronline/fulltext/2022/08000/efficacy_and_safety_of_transcutaneous_auricular.37.aspx

Efficacy and safety of transcutaneous auricular vagus ... There were no obvious side effects. These findings suggest that ta-VNS combined with conventional rehabilitation training for the treatment of acute ischemic or ...