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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks
Awards & highlights
MIND-CKD Trial Summary
This trial will investigate whether mindfulness meditation can help improve kidney function in patients with chronic kidney disease, and whether transcutaneous vagus nerve stimulation can help optimize the effects of mindfulness meditation and restore autonomic balance in these patients.
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.Check my eligibility
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.See study design
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.
MIND-CKD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is moderately to severely reduced.
MIND-CKD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in mean Muscle Sympathetic Nerve Activity (MSNA) burst frequency (BF)
Secondary outcome measures
Body Weight Changes
Change in baroreflex sensitivity (BRS)
Change in daytime burst frequency (BF)
+1 moreMIND-CKD Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based Stress Reduction (MBSR)Experimental Treatment1 Intervention
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.
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
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 with a day-long retreat.
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
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,642 Previous Clinical Trials
2,563,856 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
837 Previous Clinical Trials
669,590 Total Patients Enrolled
Jeanie ParkPrincipal Investigator - Emory University
Emory University Hospital, Emory University Hospital Midtown, Select Specialty Hospital-Atlanta
University Of Alabama School Of Medicine (Medical School)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You regularly drink more than two drinks a day if you're a man, or more than one drink a day if you're a woman.Your hemoglobin level is less than 10 grams per deciliter, which means you have severe anemia.Your heart beats too slowly, less than 55 times per minute.Your blood pressure is lower than 100/50 mm Hg.You are using another device that stimulates your nerves, like a TENS unit.You have a pacemaker or other implanted electronic or metal device.I have had surgery in the last 3 months.I have not had a heart attack or stroke in the last 6 months.You have a severe mental disorder that can cause you to lose touch with reality.I do not have any serious illnesses that could affect my survival.Problems with your body's automatic functions.You have thoughts of wanting to harm yourself.I have not changed my blood pressure medicine in the last month.I have hardening of the arteries in my neck.My blood pressure is not higher than 170/100 mm Hg.My kidney function is moderately to severely reduced.You have a hearing aid or any metal implant near your neck.My kidney function has been stable for the last 3 months.I am currently taking central α-agonists or MAO inhibitors.My kidney function is severely reduced.I have nerve damage due to diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: MBSR+sham-tVNS
- Group 2: MBSR+tVNS
- Group 3: HEP+tVNS
- Group 4: Health enhancement program (HEP)
- Group 5: Mindfulness-Based Stress Reduction (MBSR)
- Group 6: HEP+sham-tVNS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the eligibility requirements for participating in this clinical experiment?
"This research is recruiting 150 individuals with chronic kidney diseases aged between 40 and 80. To be considered for inclusion, potential participants must meet the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation criteria for stages III and IV CKD as well as demonstrate consistent renal function over a 3 month period (no greater than an eGFR decline of 1 cc/min/1.73 m2 per month)."
Answered by AI
How many individuals are currently enrolled in this trial?
"Affirmative. Clinicaltrials.gov data suggests that this study is still open for recruitment, with the first post date of September 20th 2019 and latest update on September 9th 2022. It requires a total of 150 participants to be recruited from one location."
Answered by AI
Are the qualifications of this trial restricted to those under fifty years old?
"In order to fulfill the criteria for this trial, potential participants must be in-between 40 and 80 years old."
Answered by AI
Are there any available spots to join this clinical experiment?
"Affirmative. Data on clinicaltrials.gov reveals that this trial, which was first posted in September of 2019, is actively recruiting volunteers. There are 150 vacancies to be filled at a single medical facility."
Answered by AI
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