What side effects are associated with this type of intervention?

Mindfulness Meditation (MM) and Transcutaneous Vagus Nerve Stimulation (tVNS) are emerging treatments for Chronic Kidney Disease (CKD) aimed at improving sympathetic function and restoring autonomic balance. MM is generally considered safe with minimal side effects, though some individuals may experience increased anxiety or emotional discomfort during meditation. tVNS is also relatively safe but can cause mild side effects such as skin irritation at the stimulation site, headache, or dizziness. Traditional treatments for CKD, such as medications and dialysis, can have more significant side effects, including fatigue, electrolyte imbalances, and increased risk of infections.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Chronic Kidney Disease (CKD) that directly align with the mechanisms of Mindfulness Meditation (MM) and Transcutaneous Vagus Nerve Stimulation (tVNS), which focus on improving sympathetic function and restoring autonomic balance. However, traditional treatments for CKD often include medications to control blood pressure, manage diabetes, and reduce proteinuria, such as ACE inhibitors, ARBs, and SGLT2 inhibitors. These treatments indirectly support kidney function and overall health but do not specifically target autonomic balance or sympathetic function.

What other types of research exist?

Promising novel alternatives for Chronic Kidney Disease patients in 2024 include breathing-based leg exercises, which have been shown to improve quality of life and stabilize heart rate variability, and integrated indirect forest therapy, which has demonstrated significant reductions in fatigue and physiological stress levels.

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Mindfulness + tVNS for Chronic Kidney Disease (MIND-CKD Trial)

N/A

Recruiting

Led By Jeanie Park

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stages III and IV CKD as defined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation

Be older than 18 years old

Must not have

Carotid atherosclerosis

Uncontrolled hypertension (BP≥170/100 mm Hg)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if mindfulness meditation and a device that sends electrical pulses to a nerve can help people with chronic kidney disease. These treatments aim to reduce stress and balance the nervous system, potentially improving heart health.

Who is the study for?

This trial is for adults with stable chronic kidney disease stages III and IV, without recent heart attacks or strokes, severe CKD, certain nerve conditions, extreme blood pressure levels, heavy substance use, or major surgeries in the past 3 months. Pregnant individuals or those on specific medications like MAO inhibitors are excluded.

What is being tested?

The study examines if mindfulness meditation can improve nervous system function in CKD patients and whether adding non-invasive vagus nerve stimulation enhances these benefits compared to a sham (fake) treatment.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site for tVNS users. Mindfulness programs are generally low-risk but could cause emotional distress or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is moderately to severely reduced.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have hardening of the arteries in my neck.

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My blood pressure is not higher than 170/100 mm Hg.

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I am currently taking central α-agonists or MAO inhibitors.

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My kidney function is severely reduced.

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I have nerve damage due to diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in mean Muscle Sympathetic Nerve Activity (MSNA) burst frequency (BF)

Secondary study objectives

Body Weight Changes

Change in baroreflex sensitivity (BRS)

Change in daytime burst frequency (BF)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness-Based Stress Reduction (MBSR)Experimental Treatment1 Intervention

Group II: MBSR+tVNSExperimental Treatment2 Interventions

Mindfulness-Based Stress Reduction (MBSR) tis designed to provide education about mindfulness and stress; experiential mindfulness practice, and discussion of participants' experiences with mindfulness practice. MBSR is delivered in 8 weekly 2.5-hour group sessions and one day-long retreat that occurs after the 6th session. Transcutaneous vagus nerve stimulation (tVNS) is a simple, noninvasive, self-administered adjunctive therapy, that may enhance the sympatho-inhibitory effects of mindfulness meditation (MM) in chronic kidney disease (CKD) .

Group III: HEP+tVNSExperimental Treatment2 Interventions

Health enhancement program (HEP) is designed to provide a structurally parallel, active control intervention to MBSR with health benefits in their own right, while omitting any components of mindfulness. HEP participants will meet with a health educator (a registered dietician) in a group setting for 8 weekly 2.5-hour sessions. Transcutaneous vagus nerve stimulation (tVNS) is a simple, noninvasive, self-administered adjunctive therapy, that may enhance the sympatho-inhibitory effects of mindfulness meditation (MM) in chronic kidney disease (CKD).

Group IV: MBSR+sham-tVNSActive Control2 Interventions

Mindfulness-Based Stress Reduction (MBSR) tis designed to provide education about mindfulness and stress; experiential mindfulness practice, and discussion of participants' experiences with mindfulness practice. MBSR is delivered in 8 weekly 2.5-hour group sessions and one day-long retreat that occurs after the 6th session. Sham stimulation will be delivered using a sham device that is identical in appearance and function to tVNS, but programmed to produce a lower frequency biphasic signal that can be felt by the participant without actually stimulating the vagus nerve.

Group V: Health enhancement program (HEP)Active Control1 Intervention

Group VI: HEP+sham-tVNSActive Control2 Interventions

Health enhancement program (HEP) is designed to provide a structurally parallel, active control intervention to MBSR with health benefits in their own right, while omitting any components of mindfulness. HEP participants will meet with a health educator in a group setting for 8 weekly 2.5-hour sessions. Sham stimulation is be delivered using a sham device that is identical in appearance and function to tVNS, but programmed to produce a lower frequency (0.1 Hz) biphasic signal that can be felt by the participant without actually stimulating the vagus nerve.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness-based stress reduction (MBSR)

2014

N/A

~250

Transcutaneous Vagus Nerve Stimulation (tVNS)

2018

Completed Phase 2

~40

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mindfulness Meditation (MM) and Transcutaneous Vagus Nerve Stimulation (tVNS) are emerging treatments for Chronic Kidney Disease (CKD) that focus on modulating the autonomic nervous system. MM improves sympathetic function by reducing stress and promoting relaxation, which can lower blood pressure and improve kidney function. tVNS stimulates the vagus nerve to enhance its inhibitory effects on the sympathetic nervous system, restoring autonomic balance. This can reduce inflammation, lower blood pressure, and improve heart rate variability, all of which are beneficial for slowing the progression of CKD.

Hemodynamic theory of progressive renal disease: a 10-year update in brief review.Current therapeutic strategies in cardiorenal syndrome.Rapidly deteriorating renal function with membranoproliferative glomerulonephritis Type 1 associated with hepatitis C treated successfully with steroids and antiviral therapy: a case report and review of literature.