60 Participants Needed

Non-Invasive Vagus Nerve Stimulation for Stroke Recovery

(NOVIS Trial)

SI
RM
Overseen ByRachel Markley, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Methodist Hospital Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 taVNS for stroke recovery?

Research shows that non-invasive vagus nerve stimulation (taVNS) can improve motor and sensory function in stroke patients, similar to invasive methods but without the need for surgery. Studies indicate that taVNS, when combined with rehabilitation, may enhance recovery by activating similar pathways in the brain as invasive techniques.12345

Is transcutaneous auricular vagus nerve stimulation (taVNS) safe for humans?

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally considered safe, with mild and temporary side effects like ear pain, headache, and tingling. A large review of studies found no serious adverse events directly linked to taVNS, making it a safe option for clinical use.13678

How does the treatment taVNS differ from other treatments for stroke recovery?

taVNS is a non-invasive treatment that stimulates the vagus nerve through the ear, unlike invasive methods that require surgery. It may improve motor and sensory function in stroke patients by promoting brain recovery processes like reducing inflammation and enhancing blood flow.123910

What is the purpose of this trial?

To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery

Research Team

TH

Timea Hodics, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

This trial is for adults over 18 who had a stroke at least 6 months ago and have some movement limitations but can follow simple commands. It's open to all races and genders. People with severe muscle stiffness or those who cannot safely receive non-invasive VNS therapy are excluded.

Inclusion Criteria

I am over 18 years old.
I had a stroke that caused weakness on one side of my body.
I can move my shoulder, elbow, wrist, and hand normally.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive non-invasive trans-auricular vagus nerve stimulation (taVNS) during occupational therapy for motor recovery

6 weeks
Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks
Post intervention assessments at week 12 and week 18

Open-label extension

Participants in the sham group may receive active taVNS in a cross-over phase to assess sustained clinical improvement

6 weeks

Treatment Details

Interventions

  • taVNS
Trial Overview The study tests the safety and effectiveness of non-invasive vagus nerve stimulation (taVNS) as a treatment to improve recovery after a stroke. Participants will undergo taVNS therapy to see if it helps in regaining motor functions.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: taVNSExperimental Treatment1 Intervention
Weak current (up to 0.8-4 mA) will be delivered using pulses according to standard protocol during each motor task for up to 90-minutes through surface electrodes which will be administered using the intensity identified as resulting in well tolerated skin sensation and best motor performance during our initial testing session.
Group II: Sham StimulationPlacebo Group1 Intervention
Same procedure as with the active stimulation using the device's sham settings to elicit the same cutaneous sensation as the other stimulation conditions..

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials
299
Recruited
82,500+

Findings from Research

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.
Transcutaneous vagus nerve stimulation (tVNS) in stroke: the evidence, challenges and future directions.Baig, SS., Kamarova, M., Ali, A., et al.[2022]
In a study involving 12 chronic stroke patients, noninvasive transcutaneous auricular vagus nerve stimulation (taVNS) combined with repetitive motor practice showed potential to improve sensory recovery, with 64% of participants regaining some sensation after treatment.
The results suggest that taVNS may enhance sensory recovery alongside motor rehabilitation, but further research with a larger group is needed to fully understand its effects on overall functional recovery.
Transcutaneous Auricular Vagus Nerve Stimulation with Upper Limb Repetitive Task Practice May Improve Sensory Recovery in Chronic Stroke.Baig, SS., Falidas, K., Laud, PJ., et al.[2020]
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.
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]

References

Transcutaneous vagus nerve stimulation (tVNS) in stroke: the evidence, challenges and future directions. [2022]
Transcutaneous Auricular Vagus Nerve Stimulation with Upper Limb Repetitive Task Practice May Improve Sensory Recovery in Chronic Stroke. [2020]
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]
Vagus nerve stimulation paired with rehabilitation for motor function, mental health and activities of daily living after stroke: a systematic review and meta-analysis. [2023]
tVNS in Stroke: A Narrative Review on the Current State and the Future. [2023]
Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]
Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. [2020]
Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke. [2019]
Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Clinical Research Progress of the Post-Stroke Upper Limb Motor Function Improvement via Transcutaneous Auricular Vagus Nerve Stimulation. [2023]
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