taVNS for Nephrotic Syndrome in Children
(kidNEY-VNS Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northwell Health
Must not be taking: Steroids, Immunosuppressants
Disqualifiers: Secondary nephrotic syndrome, Cardiac disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a new treatment for children with frequently relapsing nephrotic syndrome using a device that sends gentle electrical pulses to the ear. The goal is to see if this method can safely help manage their condition by reducing inflammation through nerve stimulation.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have been exposed to steroids within 14 days of enrollment or are receiving any standing immunosuppression.
What data supports the idea that taVNS for Nephrotic Syndrome in Children is an effective treatment?
The available research does not provide specific data supporting the effectiveness of taVNS for Nephrotic Syndrome in Children. However, it does show that taVNS has been beneficial in treating other conditions, such as reducing inflammation in inflammatory bowel disease in children and helping with heart rhythm issues. This suggests that taVNS might have potential benefits for other inflammatory or immune-related conditions, but more specific research is needed for Nephrotic Syndrome in Children.
12345What safety data exists for taVNS treatment in children with nephrotic syndrome?
The pilot study titled 'Transcutaneous auricular vagus nerve stimulation (taVNS) for the treatment of pediatric nephrotic syndrome' suggests that taVNS is being explored as a treatment for immune-mediated illnesses like nephrotic syndrome in children. However, the provided research does not include specific safety data for taVNS in this context. Further studies or clinical trials would be needed to establish detailed safety data.
678910Is the treatment taVNS a promising treatment for Nephrotic Syndrome in children?
The information provided does not directly address the effectiveness or promise of taVNS for treating Nephrotic Syndrome in children. The articles focus on vascular access for hemodialysis in children with kidney issues, not on taVNS or its potential benefits.
1112131415Eligibility Criteria
This trial is for children aged 3-17 with frequently relapsing nephrotic syndrome, specifically those diagnosed with Minimal Change Disease or Focal Segmental Glomerulosclerosis. They must be in remission and have responded to steroids before. Kids can't join if they've taken steroids recently, are on other immunosuppressants, have electronic implants, are pregnant, or have certain heart diseases or inflammatory conditions.Inclusion Criteria
I am between 3 and 17 years old.
I have been diagnosed with MCD or FSGS.
My kidney function, measured by eGFR, is at least 30.
+3 more
Exclusion Criteria
Pregnancy
I have an inflammatory condition like lupus.
You have an implanted electronic device.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
up to 8 weeks
Randomized Control Period
Participants are randomized to either taVNS or sham treatment and perform daily therapy for 26 weeks
26 weeks
In-person visits at Weeks 8, 16, and 26; virtual visits at Weeks 4, 12, and 20
Follow-up
Participants are monitored for clinical status and nephrotic syndrome relapses after the randomized period
26 weeks
In-person or telehealth visits every 8 weeks
Open-label Extension (optional)
Participants may opt to receive active taVNS treatment after the randomized period
Participant Groups
The study tests transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive treatment that might regulate the immune system without drugs' side effects. Children will be randomly assigned to either real taVNS therapy or a sham device to compare effectiveness and impact on inflammation markers.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention GroupExperimental Treatment1 Intervention
The intensity setting for pulse amplitude will be adjusted to the participant's tolerance (if a sensation is felt) to a maximum level of 3 on the dial indicator. The remaining settings will be stored in the device and will not need to be set for each treatment. Participants and guardians will be instructed to adjust intensity to highest level of tolerance each time the device is used and level will be logged.
Group II: Sham GroupPlacebo Group1 Intervention
The sham device will be disabled internally so that electrical stimulation is not delivered, but the device will appear to function. Externally, the sham device will look identical to the taVNS device. The participant will be told to increase the intensity until tolerated if a sensation is felt, but will be asked to stop at a maximum level of 3. This inactive sham method was chosen because previous studies have shown that stimulation with placement of the ear clip on other parts of the ear such as the earlobe, although not innervated by the vagus nerve, results in some vagus nerve activity. Inactive sham methodology has been used in previous studies.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cohen Children's Medical CenterNew Hyde Park, NY
Children's Hospital of PhiladelphiaPhiladelphia, PA
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Who Is Running the Clinical Trial?
Northwell HealthLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Noninvasive Vagus Nerve Stimulation in Postural Tachycardia Syndrome: A Randomized Clinical Trial. [2023]Low-level transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus is antiarrhythmic and anti-inflammatory in animals and humans. Preliminary studies show that transcutaneous vagus nerve stimulation (tVNS) is beneficial in animal models of postural tachycardia syndrome (POTS).
Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. [2023]Transcutaneous auricular vagus nerve stimulation (TaVNS) is a supplementary treatment for gastric symptoms resulting from dysrhythmias. The main objective of this study was to quantify the effects of 10, 40, and 80 Hz TaVNS and sham in healthy individuals in response to a 5-minute water-load (WL5) test.
Transcutaneous vagus nerve stimulation and the realm of its therapeutic hopes and physiologic enigmas. [2022]Vagus nerve stimulation (VNS) is an established treatment option for patients with treatment resistant epilepsy and depression. However, the procedure is invasive and has side-effects. Transcutaneous vagus nerve stimulation (tVNS) is a non-invasive alternative. Particularly transcutaneous stimulation at the outer ear is gaining increasing interest. While the scope of therapeutic tVNS applications is expanding, there are still questions regarding the optimal stimulation parameters and site as well as the physiology and pathways of auricular tVNS. This Special Issue of Autonomic Neuroscience: Basic & Clinical provides an introduction and overview on basic aspects as well as special topics of tVNS.
Vagus nerve stimulation reduces ventricular arrhythmias and increases ventricular electrical stability. [2019]Transcutaneous stimulation of the auricular branch of the vagus nerve (AB-VNS) is a potentially noninvasive, inexpensive, and safe approach for vagus nerve stimulation that suppresses the induction and duration of atrial fibrillation and reduces sympathetic nerve outflow in healthy humans. Researchers have not determined whether AB-VNS affects ventricular arrhythmias.
Transcutaneous auricular vagus nerve stimulation attenuates inflammatory bowel disease in children: a proof-of-concept clinical trial. [2023]Vagus nerve stimulation is an investigational anti-inflammatory therapy targeting the nervous system to modulate immune activity. This study evaluated the efficacy and safety of transcutaneous auricular VNS (ta-VNS) in patients with pediatric-onset Crohn's disease (CD) or ulcerative colitis (UC).
Transcutaneous auricular vagus nerve stimulation (taVNS) for the treatment of pediatric nephrotic syndrome: a pilot study. [2022]Children with frequently relapsing nephrotic syndrome (FRNS) and steroid resistant nephrotic syndrome (SRNS) are exposed to immunosuppressant medications with adverse side effects and variable efficacy. Transcutaneous auricular vagus nerve stimulation (taVNS) modulates the immune system via the inflammatory reflex and has become a therapy of interest for treating immune-mediated illnesses.
The 1994 annual report of the North American Pediatric Renal Transplant Cooperative Study. [2019]The North American Pediatric Renal Transplant Cooperative Study (NAPRTCS) is a research effort that was organized and initiated in 1987. The following manuscript is the 1994 NAPRTCS annual report which has summarized data that has been voluntarily contributed by 83 centers. The report includes data on 3,183 patients who have undergone a total of 3,445 renal transplants between 1 January 1987 and 18 February 1994 when the data set was closed. The report also contains data on 1,611 independent courses of dialysis which were initiated between 1 January 1992 and 18 February 1994. This report is meant to update the previous NAPRTCS annual reports as well as demonstrate how the NAPRTCS database has changed clinical practice since its inception. There have been 855 graft failures among the 3,438 transplants. Due to the maturing of the database, chronic rejection now accounts for 34% of graft failures which have occurred over the last year. Graft failure was increased in recipients if the recipients were 6 years did not have catch-up growth post transplant. Overall graft survival has improved markedly since the inception of this study. The dialysis database is just maturing and the data confirm that growth on dialysis continues to be very poor. The 1994 annual report of NAPRTCS extends previous findings of this valuable database. It is gratifying to know that early findings of NAPRTCS have led to changes in therapy which have led to improvement in the care of these very special children.
Cerebral venous thrombosis in the nephrotic syndrome. [2008]A 4-year-old boy with idiopathic steroid responsive nephritic syndrome developed bilateral sixth-nerve palsy and lethargy secondary to cerebral sinus thrombosis. Treatment with heparin, fresh frozen plasma as source of antithrombin III and vitamin K inhibitors may have prevented further sequels. However, anti-coagulation, as assessed by partial thromboplastin and prothrombin time, was difficult to achieve. Despite these problems the child made a complete neurological recovery.
The safety and efficacy of mycophenolate mofetil in children and adolescents with steroid-dependent nephrotic syndrome: a single-centre study. [2022]Steroid-dependent nephrotic syndrome (SDNS) patients experience frequent relapse or adverse effects on long-term treatment with steroids or cyclophosphamide. This study assessed the efficacy and side effect profile of mycophenolate mofetil (MMF) therapy in children with nephrotic syndrome in our population.
[Glucocorticoid administration in steroid sensitive nephritic syndrome: a meta-analysis]. [2008]To evaluate the benefits and toxicities of different corticosteroid regimes in preventing relapse in children with steroid sensitive nephrotic syndrome (SSNS).
Experience with autogenous arteriovenous access for hemodialysis in children and adolescents. [2017]The National Kidney Foundation's DOQI-NKF recommendation to construct an autogenous arteriovenous access (AAVA) for chronic hemodialysis whenever possible can be a challenge in the pediatric population. This report reviews recent surgical experience in this patient subgroup. From March 1999 to April 2004, 47 consecutive children requiring permanent vascular access had construction of AAVA. There were 16 girls and 31 boys, with a mean age of 14.6 years (range 5-20). The surgeon preoperatively mapped veins with ultrasound in all patients. Access sites were radial-cephalic (n = 16), upper arm brachial-cephalic (n = 15), transposed upper arm brachial-basilic (n = 7), and transposed femoral vein (n = 9). An operating microscope was used to construct three radial-cephalic accesses in individuals with small arteries. Three forearm cephalic veins were transposed (one at the original surgical procedure and two postoperatively). Five upper arm cephalic veins were transposed (three at the original surgical procedure and two postoperatively). Femoral vein accesses were constructed for either exhausted access in the upper extremities (n = 7) or patient preference (n = 2). Primary patency at 1 and 2 years was 100% and 96%, respectively. Secondary patency at 1 and 2 years was 100%. One individual with a radial-cephalic AAVA and severe radial artery calcification required an inflow procedure. Thirty-five accesses are currently in use (functionally patent), eight are in individuals with successful renal transplants, and two are maturing; one individual declines using the access. Two accesses are secondarily patent (thrombosed and repaired 12 and 29 months after construction, respectively), and one access thrombosed after 27 months (abandoned). Construction of an AAVA is possible in virtually all pediatric age individuals if attention is given to preoperative vein mapping, selective use of an operating microscope, and creation of a transposed femoral vein when upper extremity access is neither possible nor desired.
Vascular access in children on chronic hemodialysis: a Slovenian experience. [2018]The aim of our study was to report our experience with arteriovenous fistulas (AVFs) and non-cuffed central venous catheters (CVCs) in children and adolescents with end-stage renal disease (ESRD) on hemodialysis (HD). The children with ESRD (18 years or younger) who were hemodialyzed at the Center of Dialysis and Transplantation, Children's Hospital, Ljubljana, in the period between December 1998 and December 2010 were included in our retrospective study. We recorded the data considering the CVCs and AVFs used for HD. Thirty-one children (13 females, 18 males) with ESRD received HD treatment. The mean patient age when HD was started was 13.3 ± 3.4 years. Altogether, 35 AVFs were created, and the primary failure rate was 25.7% (9/35). The time to maturation was 4.0 ± 2.5 months. The mean patency of the AVF was 42.5 ± 51.9 months. Seventy-seven CVCs (non-cuffed) were inserted in the observation period; 89.6% of the CVCs were inserted in the jugular vein, and citrate locking was used in the interdialysis period. The CVCs were removed after 0.1-17.4 months (3.6 ± 3.7 months). The incidence of bacteremia was 0.9 episodes per 1000 catheter days. The preferred vascular accesses for pediatric hemodialysis are native AVFs; however, a single lumen, non-cuffed, citrate-locked CVC placed in a jugular vein can be acceptable as a long-term vascular access when AVF cannot be constructed or used.
Vascular access in children requiring maintenance haemodialysis: a consensus document by the European Society for Paediatric Nephrology Dialysis Working Group. [2021]There are three principle forms of vascular access available for the treatment of children with end stage kidney disease (ESKD) by haemodialysis: tunnelled catheters placed in a central vein (central venous lines, CVLs), arteriovenous fistulas (AVF), and arteriovenous grafts (AVG) using prosthetic or biological material. Compared with the adult literature, there are few studies in children to provide evidence based guidelines for optimal vascular access type or its management and outcomes in children with ESKD.
Long-term outcomes of staged basilic vein transposition for hemodialysis access in children. [2018]Children requiring long-term hemodialysis often face significant challenges due to their young age and small-vessel caliber for arteriovenous (AV) access creation. In this study, we report our experience of staged basilic vein transposition (BVT) in pediatric patients.
Patterns of use of vascular catheters for hemodialysis in children in the United States. [2018]Arteriovenous fistulas (AVFs) and grafts (AVGs) have been associated with improved clinical outcomes in children and adults with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy, but use of vascular catheters is high. Identifying the reasons for the high prevalence of vascular catheters in children on HD therapy is necessary to assess whether targeted interventions may increase the prevalence of AVFs/AVGs.