At-Home TaVNS for Stroke Rehabilitation

Overseen By Katie Tucker

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Botox

Disqualifiers: Neurological disorders, Dysphagia, Pregnancy, Dementia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to improve arm movement recovery after a stroke by combining special ear stimulation (Remote Transcutaneous Auricular Vagal Nerve Stimulation) with rehab exercises. Stimulating the ear may enhance the effects of the exercises. It targets individuals who had a stroke over six months ago and have some arm movement but still need help regaining strength and control. Participants should be able to move their wrist and fingers enough to perform rehab tasks at home. The trial excludes those with other nerve issues or significant swallowing problems. As an unphased trial, it offers a unique opportunity to explore innovative recovery methods and contribute to advancing stroke rehabilitation techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have uncontrolled hypertension or have had Botox injections within 4 weeks of starting the therapy, you may not be eligible to participate.

What prior data suggests that this method is safe for stroke rehabilitation?

Research has shown that using a device to gently stimulate the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS), is generally safe when combined with stroke rehabilitation. Studies have found that pairing taVNS with regular rehabilitation exercises improves movement and sensation without major safety issues. Participants in these studies reported no serious side effects, indicating that the treatment is well-tolerated. This evidence suggests that taVNS is a safe option for many people recovering from a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Remote Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) for stroke rehabilitation because it offers a new, non-invasive approach to aid recovery. Unlike traditional therapies, which might involve medications or physical therapy alone, taVNS uses electrical stimulation of the vagus nerve to potentially enhance brain plasticity and improve motor function. This innovative treatment is paired with task-specific training and can be administered at home, making it more accessible and convenient for patients. The unique combination of nerve stimulation and targeted exercises could accelerate rehabilitation, offering a promising alternative to standard care.

What evidence suggests that Remote Transcutaneous Auricular Vagal Nerve Stimulation might be an effective treatment for stroke rehabilitation?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) can significantly aid stroke survivors in regaining movement and sensation. In this trial, participants will receive Remote Transcutaneous Auricular Vagal Nerve Stimulation combined with task-specific training. When paired with specific exercises, taVNS can enhance arm function. Studies have found that taVNS leads to better recovery outcomes, particularly for those with arm movement difficulties. Animal studies demonstrated that taVNS reduces brain damage from strokes, which is promising for its application in humans. Additionally, taVNS has proven effective in addressing emotional issues like depression after a stroke, making it a valuable tool in recovery. ^{1 3 5 6 7}

Who Is on the Research Team?

Bashar W Badran, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for stroke survivors with upper limb motor function deficits who can perform rehabilitation exercises at home. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and be able to follow the study procedures.

Inclusion Criteria

Ability to give consent

My shoulder, elbow, and wrist move almost as well as normal.

I have weakness in one arm but can still use it for rehab tasks.

Exclusion Criteria

I have a neurological condition that affects my arm or hand movement.

Prior injury to vagus nerve

I haven't had Botox injections in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lab-based Testing and Validation

Lab-based testing and validation of the stimulation triggering sensors for at-home use

2 weeks

Treatment

Task-specific training paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting

2 weeks

3 visits per week (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote Transcutaneous Auricular Vagal Nerve Stimulation

Trial Overview The trial tests a new method combining electrical stimulation of the ear (taVNS) with task-specific training to improve arm function after a stroke. Participants will do this therapy at home, exploring its potential benefits in a comfortable setting.

How Is the Trial Designed?

Group I: Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task Specific Training Experimental Treatment 1 Intervention

Task-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting.

Remote Transcutaneous Auricular Vagal Nerve Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as taVNS for:

• Epilepsy
• Depression
• Tinnitus
• Stroke rehabilitation

Approved in European Union as taVNS for:

• Epilepsy
• Depression
• Tinnitus
• Stroke rehabilitation

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Published Research Related to This Trial

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]

In a pilot trial with 20 stroke survivors, the closed-loop transcutaneous auricular vagus nerve stimulation (MAAVNS) paired with motor rehabilitation showed greater improvement in upper limb function compared to unpaired taVNS, with a higher effect size (Cohen's d = 0.63 vs. 0.30).

Participants receiving MAAVNS required significantly fewer stimulation pulses (36,070) than those receiving unpaired taVNS (45,000), suggesting that the timing and synchronization of stimulation with movement are critical for enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study. Badran, BW., Peng, X., Baker-Vogel, B., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe and effective neuromodulation therapy for a variety of conditions, including epilepsy, depression, and anxiety, indicating its broad therapeutic potential.

Despite its effectiveness, there is currently no standardization among taVNS devices, and further research is needed to clarify the relationship between stimulation parameters and therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. Wang, L., Wang, Y., Wang, Y., et al.[2022]

In a pilot study involving 40 acute stroke patients, transcutaneous auricular electrical vagus nerve stimulation (ta-VNS) significantly improved swallowing function compared to a sham treatment, with benefits observed immediately after treatment and lasting for at least 4 weeks.

The study found no serious adverse events associated with ta-VNS, indicating it is a safe and noninvasive option for treating dysphagia in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transcutaneous auricular vagus nerve stimulation on post-stroke dysphagia. Wang, Y., He, Y., Jiang, L., et al.[2023]

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 generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.

In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Kim, AY., Marduy, A., de Melo, PS., et al.[2023]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8820701/

Efficacy and safety of transcutaneous auricular vagus ... ta-VNS combined with conventional rehabilitation training greatly improved the recovery of motor and sensory functions and emotional responses.

2. 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.

3. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1346634/full

Transcutaneous auricular vagus nerve stimulation with task ... This study aimed to investigate the effects of taVNS paired with task-oriented training (TOT) on upper extremity function in patients with subacute stroke.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032724004191

Transcutaneous auricular vagus nerve stimulation for post- ... ta-VNS has been proven effective as adjunctive therapy in patient with post-stroke depression. •. The synergistic approach of combining ta-VNS ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/np/9927826

Effects of Transcutaneous Auricular Vagus Nerve ... This meta-analysis showed augmented effect of taVNS on rehabilitation therapy in paretic upper limb motor function poststroke, especially ...

6. 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 ... These findings suggest that ta-VNS combined with conventional rehabilitation training for the treatment of acute ischemic or hemorrhagic stroke patients is safe ...

7. 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 ...