30 Participants Needed

Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Kidney Disease

QS
DC
Overseen ByDavid Charytan, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
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 Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Chronic Kidney Disease?

Research shows that transcutaneous auricular vagus nerve stimulation (taVNS) can have beneficial effects on heart rate and reduce inflammation, which might be helpful for conditions like chronic kidney disease. Additionally, taVNS has been shown to stabilize heart rhythms and reduce stress on the heart, suggesting potential benefits for kidney health.12345

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

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally considered safe for humans, with only mild and temporary side effects like ear pain, headache, and tingling. A large review found no serious adverse effects linked to taVNS, making it a safe option for clinical use.16789

How is the treatment Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) unique for chronic kidney disease?

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) is unique because it uses low-intensity electrical currents applied to the ear to stimulate the vagus nerve, which is different from traditional treatments that might involve medication or dialysis. This non-invasive approach aims to leverage the nerve's role in regulating bodily functions, potentially offering anti-inflammatory benefits without the need for drugs.123510

What is the purpose of this trial?

30 patients will participate in a prospective randomized clinical trial to test the safety, tolerability and efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) for autonomic nervous system (ANS) dysfunction in the chronic kidney disease (CKD) stage 3-5 setting.

Research Team

QS

Qandeel Soomro, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for individuals with chronic kidney disease stages 3-5. It's designed to see if a non-invasive nerve stimulation technique can help with nervous system issues related to their condition.

Inclusion Criteria

My kidney function is moderately to severely reduced.
Receiving care at NYU Nephrology outpatient practice
Able to provide informed consent

Exclusion Criteria

I have epilepsy.
Presence of a permanent pacemaker
Pregnant individuals
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either sham or active taVNS for two weeks, with daily 15-minute sessions

2 weeks
14 sessions (daily)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

  • Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Trial Overview The study tests transcutaneous auricular vagus nerve stimulation (taVNS), comparing an active device against a sham (inactive) one in a small group of patients, to assess its safety and effectiveness.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active taVNSExperimental Treatment1 Intervention
Participants receive two weeks of 15-minute taVNS daily in the morning.
Group II: Sham taVNSPlacebo Group1 Intervention
Participants receive two weeks of 15-minute sham intervention daily in the morning.

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

Transcutaneous auricular vagus nerve stimulation (TaVNS) effectively normalized gastric dysrhythmias in healthy individuals during a water-load test, indicating its potential as a treatment for gastric symptoms.
The study found that TaVNS at 40 Hz improved heart rate variability and reduced bloating, suggesting it positively influences both parasympathetic and sympathetic nervous system pathways.
Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping.Du, P., Maharjan, A., Calder, S., et al.[2023]
A systematic review of 261 studies revealed significant confusion in the nomenclature for transcutaneous stimulation of the auricular branch of the vagus nerve (ABVN), with 67 full and 27 abbreviated terms identified, highlighting the need for standardization.
The most commonly used terms were 'transcutaneous vagus nerve stimulation' and 'tVNS', but there was no consistent one-to-one relationship between full and abbreviated names, indicating a lack of uniformity in terminology across different research teams.
Toward Diverse or Standardized: A Systematic Review Identifying Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve in Nomenclature.Wang, Y., Li, L., Li, S., et al.[2023]
Transcutaneous auricular vagus nerve stimulation (taVNS) using specific parameters (500μs pulse width at 10Hz and 25Hz) was found to significantly decrease heart rate (HR) in healthy individuals, indicating its potential efficacy in modulating HR.
The study demonstrated that taVNS is safe, with no adverse effects reported, and it effectively attenuated sympathetic HR rebound after stimulation, suggesting a beneficial impact on autonomic regulation.
Short trains of transcutaneous auricular vagus nerve stimulation (taVNS) have parameter-specific effects on heart rate.Badran, BW., Mithoefer, OJ., Summer, CE., et al.[2020]

References

Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. [2023]
Toward Diverse or Standardized: A Systematic Review Identifying Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve in Nomenclature. [2023]
Short trains of transcutaneous auricular vagus nerve stimulation (taVNS) have parameter-specific effects on heart rate. [2020]
Vagus nerve stimulation reduces ventricular arrhythmias and increases ventricular electrical stability. [2019]
Noninvasive Vagus Nerve Stimulation in Postural Tachycardia Syndrome: A Randomized Clinical Trial. [2023]
The efficacy and safety of transcutaneous auricular vagus nerve stimulation in the treatment of depressive disorder: A systematic review and meta-analysis of randomized controlled trials. [2023]
Optimizing the modulation paradigm of transcutaneous auricular vagus nerve stimulation in patients with disorders of consciousness: A prospective exploratory pilot study protocol. [2023]
Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]
Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS). [2023]
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