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

Trial Summary

What is the purpose of this trial?

Early evidence suggests the benefits of post-stroke motor rehabilitation may be enhanced by applying electrical stimulation to the ear. This study aims to test the new approach of pairing ear stimulation with motor rehabilitation in the home setting in stroke survivors with upper limb motor function deficits.

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 data supports the effectiveness of the treatment Remote Transcutaneous Auricular Vagal Nerve Stimulation for stroke rehabilitation?

Research shows that transcutaneous auricular vagus nerve stimulation (taVNS) combined with conventional rehabilitation can improve motor and sensory functions in stroke patients, with no significant side effects. Studies also suggest that taVNS may help with recovery of upper limb motor function and promote neurological recovery after stroke. ^{1 2 3 4 5}

Is at-home taVNS safe for humans?

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally considered safe for humans, with mild and temporary side effects like ear pain, headache, and tingling. A large review found no serious adverse events linked to taVNS, making it a safe option for clinical use. ^{1 3 6 7 8}

How is the treatment At-Home TaVNS for Stroke Rehabilitation different from other treatments for stroke?

At-Home TaVNS for Stroke Rehabilitation is unique because it is a non-invasive treatment that stimulates the vagus nerve through the ear, which can enhance recovery of motor and sensory functions after a stroke without the need for surgery or implanted devices. ^{1 2 3 8 9}

Research Team

Bashar W Badran, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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

I am between 18 and 80 years old and had a stroke more than 6 months ago.

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

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

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

Treatment Details

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.

Participant Groups

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+

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 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]

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 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) 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]

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]

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]

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

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

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

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

5. Germany pubmed.ncbi.nlm.nih.gov

Effect of transcutaneous auricular vagus nerve stimulation on post-stroke dysphagia. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. [2022]

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

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

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

Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study. [2023]