Mindfulness in Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

— MIND-CKD  

Official title:

Sympatho-inhibition With Mindfulness in Chronic Kidney Disease (MIND-CKD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04099992
• Other study ID #: IRB00110956
• Secondary ID: 5R61AT0104574R33
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: August 2025

Study information

• Verified date: September 2023
• Source: Emory University
• Contact: Jeanie Park, MD
• Phone: 404-727-2525
• Email: jeanie.park[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test whether mindfulness meditation (MM) improves sympathetic function in chronic kidney disease (CKD) and whether transcutaneous vagus nerve stimulation (tVNS) optimizes the sympatho-inhibitory effects of mindfulness meditation (MM) and restores autonomic balance in CKD patients.

Description:

~30 million people in the US have chronic kidney disease (CKD) and are at 5-15 fold greater risk of cardiovascular (CV) disease and mortality. A major factor contributing to increased CV risk in these patients is chronic elevation of sympathetic nervous system (SNS) activity. New therapeutic strategies to safely and effectively ameliorate SNS over-activity are of paramount importance to improve clinical outcomes in this highly prevalent and high-risk patient population. This study will test whether mindfulness meditation (MM) improves sympathetic function in chronic kidney disease (CKD) and whether transcutaneous vagus nerve stimulation (tVNS) optimizes the sympatho-inhibitory effects of mindfulness meditation (MM) and restores autonomic balance in CKD patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• stages III and IV CKD as defined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
• stable renal function (no greater than a decline of eGFR of 1 cc/min/1.73 m2 per month over the prior 3 months)

Exclusion Criteria:

• severe CKD (eGFR<15 cc/min)
• diabetic neuropathy
• autonomic dysfunction
• any serious disease that might influence survival
• anemia with hemoglobin <10 g/dL
• treatment with central a-agonists or monoamine oxidase (MAO) inhibitors
• myocardial infarction or cerebrovascular accident within the past 6 months
• uncontrolled hypertension (BP=170/100 mm Hg)
• low BP (BP<100/50 mm Hg)
• bradycardia (HR<55 beats/min)
• ongoing drug or alcohol abuse (defined as >2 drinks/day in men, and >1 drink/day in women)
• surgery within the past 3 months
• adjustment of antihypertensive medications within the past month
• pregnancy or plans to become pregnant
• psychosis
• suicidal ideation
• implanted electronic or metallic device such as a pacemaker
• implanted hearing aid, bone plate, carotid stent, bone screw at or near the neck
• carotid atherosclerosis
• concurrent use of another stimulating device such as a transcutaneous electrical nerve stimulation (TENS) unit.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Mindfulness-based stress reduction (MBSR)
Mindfulness-based stress reduction (MBSR) is delivered in 8 weekly 2.5-hour group sessions and one day-long retreat that occurs after the 6th session. MBSR teaches to become more aware of thoughts, feelings, and sensations, and to skillfully respond to stressors. Each of the sessions includes education about mindfulness and stress; experiential mindfulness practice, and discussion of participants' experiences with mindfulness practice. Participants learn formal mindfulness practices (e.g., meditation, yoga, body scan, body scan) as well as informal such as awareness of breath, thoughts, or emotions, and mindfulness of daily activities. Participants will receive digital audio (MP3) downloads with guided MM practices, a home practice manual, and handouts with each week's assignments. Daily home practice will consist of 40-45 minutes of recorded practice. Participants will log their daily practice. If a participant misses a class, it is possible to make up the class on a different day.
• Health enhancement program (HEP)
8-week 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 matches MBSR in structure and content, and in parallel to MBSR, consists of music therapy, nutritional education, posture and balance movements, walking and stretching. Work with all practices with group discussion and exercises during an all-day "spa day" will match the all-day retreat in MBSR. HEP participants will meet with a health educator in a group setting for 8 weekly 2.5-hour sessions. Participants will receive MP3 downloads on an MP3 player with recordings of health education topics, a home listening manual, and weekly handouts with each week's listening assignments. Participants will listen to these MP3 recordings daily for 40-45 minutes and log their daily adherence.

Device:
• Transcutaneous Vagus Nerve Stimulation (tVNS)
Transcutaneous Vagus Nerve Stimulation (tVNS) is delivered using gammaCore (Electrocore), a multi-use, hand-held, rechargeable portable device consisting of a rechargeable battery, signal generating and amplifying electronics, and a button for operator control of the stimulation intensity. Conductive gel is applied to the stainless steel round discs on the device and placed vertically on the skin overlying the vagus nerve under the angle of the mandible, between the trachea and sternocleidomastoid muscle. A low-voltage electrical signal is delivered consisting of 5-kilohertz (kHz) sine wave series for 1 ms and repeated every 40 ms, with a maximum delivery of 24 V and 60 milliampere (mA) output. Stimulation amplitude is adjusted by the user and is increased until there is a vibration and slight muscle contraction in the lower face or neck. Stimulation is delivered for 2 minutes on the left side of the neck, and 2 minutes on the right side of the neck, for a total 4 minutes per one dose.
• Sham-transcutaneous Vagus Nerve Stimulation (tVNS)
Sham stimulation will be delivered using a sham device that is identical in appearance and function, but programmed to produce a lower frequency biphasic signal that can be felt by the participant without actually stimulating the vagus nerve.

Locations

Country	Name	City	State
United States	Atlanta VA Medical Center	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean Muscle Sympathetic Nerve Activity (MSNA) burst frequency (BF)	Multiunit postganglionic sympathetic nerve activity is recorded from a tungsten microelectrode inserted into the peroneal nerve with a reference microelectrode inserted in close proximity. Efferent nerve signals are amplified, filtered, rectified and integrated (time constant 0.1 s) to obtain a mean voltage display of MSNA. MSNA bursts are automatically detected using the following criteria: burst-to-noise ratio of 3:1 within a 0.5-s search window, with an average latency of 1.2-1.3 s in burst occurrence from the previous R-wave. MSNA is expressed as burst frequency (BF, bursts/min).	Baseline, 8 weeks
Secondary	Change in daytime burst frequency (BF)	Multiunit postganglionic sympathetic nerve activity is recorded from a tungsten microelectrode inserted into the peroneal nerve with a reference microelectrode inserted in close proximity. Efferent nerve signals are amplified, filtered, rectified and integrated (time constant 0.1 s) to obtain a mean voltage display of MSNA. MSNA bursts are automatically detected using the following criteria: burst-to-noise ratio of 3:1 within a 0.5-s search window, with an average latency of 1.2-1.3 s in burst occurrence from the previous R-wave. MSNA is expressed as burst frequency (BF, bursts/min).	Baseline, 8 weeks
Secondary	Change in nocturnal dipping of burst frequency (BF)	Multiunit postganglionic sympathetic nerve activity is recorded from a tungsten microelectrode inserted into the peroneal nerve with a reference microelectrode inserted in close proximity. Efferent nerve signals are amplified, filtered, rectified and integrated (time constant 0.1 s) to obtain a mean voltage display of MSNA. MSNA bursts are automatically detected using the following criteria: burst-to-noise ratio of 3:1 within a 0.5-s search window, with an average latency of 1.2-1.3 s in burst occurrence from the previous R-wave. MSNA is expressed as burst frequency (BF, bursts/min).	Baseline, 8 weeks
Secondary	Change in baroreflex sensitivity (BRS)	Afferent sympathetic baroreflex input travels to the brainstem via the glossopharyngeal and vagus nerves and integrate with brainstem centers that regulate efferent SNS (sympathetic BRS) and parasympathetic (cardiovagal BRS) outflow. BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in BP. For example, when the BP rises by 10 mmHg and IBI increases by 100 ms, BRS would be 100/10 = 10 ms/mmHg.	Baseline, 8 weeks
Secondary	Change in Tumor necrosis factor (TNF) level	Tumor necrosis factor (TNF) is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. It will be measured by blood test.	Baseline, 8 weeks