Nephrotic Syndrome in ChildrenkidNEY-VNSNCT05583942
A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)
A study testing trascutaneous auricular vagus nerve stimulation in people with Nephrotic Syndrome in Children and Minimal Change Disease, run by Northwell Health at 2 sites in United States.
Trial summary
Children with steroid resistant nephrotic syndrome (SRNS) are exposed to prolonged courses of immunosuppressant medications. Given the adverse side effect profiles and variable efficacy of these medications, there is an urgent need to identify novel and safe therapies to treat nephrotic syndrome in children. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Nephrotic Syndrome in Children, Minimal Change Disease, Focal Segmental Glomerulosclerosis
- What is being tested?
- trascutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2022to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Steroid Resistant Nephrotic Syndrome- defined as lack of remission after 4 weeks of therapy of prednisolone/prednisone at standard dose1
- Age 3-17 years
- eGFR ≥30 ml/min/1.73 m2 (by modified Schwartz formula)
- MCD or FSGS diagnosis (per biopsy)
- Urine protein:creatinine (UPC) greater than 1.0
- Stable immunosuppression and ACE inhibitor/angiotensin receptor blocker treatment regimen for at least three months
Show all 9Show fewer
- Evidence of B cell repletion for those exposed to rituximab
- Informed consent from the parent or guardian and assent from a minor of ≥ 7 years
- Ability to comply with the study protocol, in the investigator's judgment
Who cannot join
- Secondary causes of nephrotic syndrome (e.g. genetic, congenital, infectious)
- Steroid sensitive nephrotic syndrome
- History of genetic defects known to directly cause nephrotic syndrome (i.e., NPHS2 [podocin], NPHS1 [nephrin], PLCE1, WT1, or other known genetic cause)
- Any known inflammatory condition
- History of cardiac disease (arrhythmias, structural/functional abnormalities)
- Implantable electronic devices (pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators)
- Chronic rash or skin breakdown of the left ear at the cymba concha
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Cohen Children's Medical Center
New Hyde Park, New York, 11040
Suzanne Vento, RN, 718-470-3491, svento@northwell.edu
Christine B Sethna, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Kevin Meyers, MD, 215-590-2449, meyersk@chop.edu
Kevin Meyers, MD
About this study
Official title: A Pilot Randomized Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Steroid Resistant Nephrotic Syndrome in Children
Children with steroid resistant nephrotic syndrome (SRNS) are exposed to prolonged courses of immunosuppressant medications. Given the adverse side effect profiles and variable efficacy of these medications, there is an urgent need to identify novel and safe therapies to treat nephrotic syndrome in children. Stimulation of the vagus nerve, which can be activated noninvasively by transcutaneous auricular vagus nerve stimulation (taVNS), has immunomodulatory effects mediated by the inflammatory reflex and spleen. taVNS has become a therapy of interest for treating chronic immune mediated illnesses. The aims of the study are (1) To determine the feasibility of protocol implementation and tolerability of taVNS in the treatment of nephrotic syndrome in children (2) To establish proof-of-concept and generate statistical estimates of variance parameters and effect sizes for treatment response outcomes in children with nephrotic syndrome randomized to taVNS therapy compared with sham therapy (3) To investigate the effects of taVNS on inflammatory markers in children with nephrotic syndrome.
Read the detailed description
A parallel, double blinded, randomized placebo controlled trial comparing daily taVNS use with sham therapy will be conducted in children 3 to 17 years of age with SRNS. Ten participants with SRNS, defined as lack of response to steroids after 4 weeks, will be randomized 1 to 1 to taVNS or sham therapy. Participants will be enrolled at two pediatric tertiary hospitals over a two year time period, with completion of the study by year three. All participants will perform daily taVNS therapy (active for taVNS arm or inactive for sham arm) for 5 minutes each day for a total of 26 weeks.
Participants will monitor heart rate with each treatment and log home urine results. Participants will be monitored monthly with in person study visits at Weeks 8, 16 and 26 alternating with virtual telehealth visits at Weeks 4, 12 and 20. Biosample specimens will be collected at baseline, 8 weeks, 16 weeks and 26 weeks. There will be a follow up period of an additional 26 weeks. All participants will be given the option to receive the active taVNS treatment at the end of the randomized period.
Study Phases The study will consist of three parts. Part 1 - Screening Period- up to 8 weeks. Informed consent/assent will be obtained at screening prior to the conduct of any study-related procedures. Participants will be screened to confirm inclusion/exclusion criteria are met. Participants must be off steroid treatment for 14 days prior to Day 1 and the participant must be in remission (negative UPC on first morning urine) on Day 1.
Part 2 - Randomized Control Period - 26 weeks: Thirty participants with FRNS who meet all of the eligibility criteria will be randomized 1:1 to either taVNS or sham treatment. A trainer will instruct the parent/guardian on use of the device at the randomization visit. Participants will use the intervention device as directed for 5 minutes per day for 26 weeks. Participants will be monitored monthly with in-person study visits at Weeks 8, 16 and 26 alternating with virtual remote video visits at Weeks 4, 12 and 20. The visit window will be +/- 7 days. At each in person visit, we will conduct:
- Vital signs and physical examination
- Assessment for nephrotic syndrome relapses. Home urine protein logs will be reviewed.
- Blood and urine samples will be collected at each in person visit.
- Assessment of study intervention adherence. Parents/guardians will meet with the trainer and will be reoriented on taVNS device use at each visit as a safety measure. The device counter number will be recorded as a measure of adherence.
- Monitor for adverse events and tolerability: Parents/guardians will share a study log with investigators, which describes daily taVNS use, side effects, and any changes in heart rate.
At each virtual remote video visit, we will observe the participant while doing the intervention procedure, assess for nephrotic syndrome relapses, and monitor for any adverse events.
Part 3 - Follow Up Period - 26 weeks: At the completion of the randomized period, participants will be followed for an additional 26 weeks to assess clinical status. For those who stop the intervention, study visits will occur in-person during regularly scheduled clinical visits or via telehealth visit every 8 weeks, whichever is sooner. Participants will be assessed for the number of nephrotic syndrome relapses and home urine protein logs will be reviewed. First morning UPC will be recorded. All participants will be given the option to receive the active taVNS treatment at the end of the randomized period. Unblinding of treatment assignment from the randomized phase will not occur prior to consent for open-label use. As open-label extension trials may introduce significant bias, data obtained from these participants will not be considered part of this research and no statistical analysis will be carried out. However, clinical status and safety will continue to be monitored. In person study visits will occur every 8 weeks for those continuing use of taVNS.
- Conditions
- Nephrotic Syndrome in Children, Minimal Change Disease, Focal Segmental Glomerulosclerosis
- Being tested
- trascutaneous auricular vagus nerve stimulation, Sham device
- Keywords
- vagus nerve stimulation, pediatric, nephrology
- Medical subject headings
- Nephrosis, Lipoid, Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trascutaneous auricular vagus nerve stimulationDevice
Also called Roscoe TENS 7000
The device to be used is the Roscoe Medical TENS 7000, a commercially available handheld electrical pulse generator, and an ear clip to be placed at the left ear for stimulation. Custom-made ear clips with electrode gel will be placed near the entrance to the canal of the ear to provide stimulation to the auricular branch. The handheld electrical pulse generator will be programmed to deliver electrical stimulation pulses to the cymba concha stimulating the auricular branch of the vagus nerve.
Sham deviceDevice
Also called Roscoe TENS 7000
The device will appear to function but no electrical stimulation will be delivered.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Device: trascutaneous auricular vagus nerve stimulation |
| Sham Group | Sham comparator | The sham device will be altered 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. Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Pilot Trial
- Unsuccessful: main study not practicable
- None of the primary feasibility and tolerability benchmarks are met, or
- One or more of the primary benchmarks are not met and there is low likelihood of reaching benchmarks even with protocol modifications or
- Serious adverse events related to the treatment.
- Probable Success: main study practicable with modifications to protocol. One or more of the primary benchmarks are not met, but there is a high likelihood that the benchmark can be met with protocol modifications.
- Successful: main study practicable without modifications. All of the primary benchmarks are met.
Measured: Baseline to 26 weeks
Secondary outcomes (14)
Effect size for change in Change in quality of life (PedsQL)
To calculate effect sizes for continuous main trial efficacy outcomes using a t test, Cohen's d test will be used.
Measured: Baseline to 26 weeks
Effect size for change in urine protein:creatinine
To calculate effect sizes for continuous main trial efficacy outcomes using a t test, Cohen's d test will be used.
Measured: Baseline to 26 weeks
Effect size for change in lipid profile
To calculate effect sizes for continuous main trial efficacy outcomes using a t test, Cohen's d test will be used.
Measured: Baseline to 26 weeks
Effect size for change in proportion with at least a 30 percent reduction in UPC
To estimate effect sizes for dichotomous main trial efficacy outcomes using Fisher's exact test, odds ratios will be calculated outcomes using a t test, Cohen's d test will be used.
Measured: Baseline to 26 weeks
Recruitment rate
Feasibility- %
Measured: Baseline to 26 weeks
Rate of completion of study
Feasibility- %
Measured: Baseline to 26 weeks
Successful double-blinding
Feasibility- %
Measured: Baseline to 26 weeks
Treatment adherence from home logs
Feasibility- %
Measured: Baseline to 26 weeks
Adverse events
Tolerability- %
Measured: Baseline to 26 weeks
Incidence of withdrawal due to adverse events
Tolerability- %
Measured: Baseline to 26 weeks
Proof of Concept Decision Criteria
A decision of whether to move forward with a larger trial will be made based on pre-determined proof of concept decision criteria. Once data from the two pilot trials are observed and collected, 1,000 bootstrap resamples with replacement will be carried out to construct the empirical 95% confidence interval (CI) for the relative risk.
Measured: Baseline to 26 weeks
Cytokines
TNF, IL-6
Measured: Baseline to 26 weeks
Anti-nephrin antibodies
Measured: Baseline to 26 weeks
Whole blood monocyte stimulation test
Change in monocyte cytokines at baseline and 2 hours post taVNS
Measured: 0 hours, 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start19 Sep 2022
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nephrotic Syndrome in ChildrenStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blind sham controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583942
- Sponsor's protocol ID
- 22-0488-A
- Other IDs
- 1R01DK131091-01A1
- Acronym
- kidNEY-VNS
- Status last verified
- Apr 2026
- First submitted
- 26 Sep 2022
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD will be made available to other researchers.
Publications
Meliambro K, He JC, Campbell KN. Podocyte-targeted therapies - progress and future directions. Nat Rev Nephrol. 2024 Oct;20(10):643-658. doi: 10.1038/s41581-024-00843-z. Epub 2024 May 9.
PubMed 38724717
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Steroid Resistant Nephrotic Syndrome in Children
- ClinicalTrials.gov ID
- NCT05583942
- Acronym / sponsor ID
- kidNEY-VNS / 22-0488-A
- Conditions
- Nephrotic Syndrome in Children, Minimal Change Disease, Focal Segmental Glomerulosclerosis
- Keywords
- vagus nerve stimulation, pediatric, nephrology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children with steroid resistant nephrotic syndrome (SRNS) are exposed to prolonged courses of immunosuppressant medications. Given the adverse side effect profiles and variable efficacy of these medications, there is an urgent need to identify novel and safe therapies to treat nephrotic syndrome in children. Stimulation of the vagus nerve, which can be activated noninvasively by transcutaneous auricular vagus nerve stimulation (taVNS), has immunomodulatory effects mediated by the inflammatory reflex and spleen. taVNS has become a therapy of interest for treating chronic immune mediated illnesses. The aims of the study are (1) To determine the feasibility of protocol implementation and tolerability of taVNS in the treatment of nephrotic syndrome in children (2) To establish proof-of-concept and generate statistical estimates of variance parameters and effect sizes for treatment response outcomes in children with nephrotic syndrome randomized to taVNS therapy compared with sham therapy (3) To investigate the effects of taVNS on inflammatory markers in children with nephrotic syndrome.
Detailed description
A parallel, double blinded, randomized placebo controlled trial comparing daily taVNS use with sham therapy will be conducted in children 3 to 17 years of age with SRNS. Ten participants with SRNS, defined as lack of response to steroids after 4 weeks, will be randomized 1 to 1 to taVNS or sham therapy. Participants will be enrolled at two pediatric tertiary hospitals over a two year time period, with completion of the study by year three. All participants will perform daily taVNS therapy (active for taVNS arm or inactive for sham arm) for 5 minutes each day for a total of 26 weeks.
Participants will monitor heart rate with each treatment and log home urine results. Participants will be monitored monthly with in person study visits at Weeks 8, 16 and 26 alternating with virtual telehealth visits at Weeks 4, 12 and 20. Biosample specimens will be collected at baseline, 8 weeks, 16 weeks and 26 weeks. There will be a follow up period of an additional 26 weeks. All participants will be given the option to receive the active taVNS treatment at the end of the randomized period.
Study Phases The study will consist of three parts. Part 1 - Screening Period- up to 8 weeks. Informed consent/assent will be obtained at screening prior to the conduct of any study-related procedures. Participants will be screened to confirm inclusion/exclusion criteria are met. Participants must be off steroid treatment for 14 days prior to Day 1 and the participant must be in remission (negative UPC on first morning urine) on Day 1.
Part 2 - Randomized Control Period - 26 weeks: Thirty participants with FRNS who meet all of the eligibility criteria will be randomized 1:1 to either taVNS or sham treatment. A trainer will instruct the parent/guardian on use of the device at the randomization visit. Participants will use the intervention device as directed for 5 minutes per day for 26 weeks. Participants will be monitored monthly with in-person study visits at Weeks 8, 16 and 26 alternating with virtual remote video visits at Weeks 4, 12 and 20. The visit window will be +/- 7 days. At each in person visit, we will conduct:
- Vital signs and physical examination
- Assessment for nephrotic syndrome relapses. Home urine protein logs will be reviewed.
- Blood and urine samples will be collected at each in person visit.
- Assessment of study intervention adherence. Parents/guardians will meet with the trainer and will be reoriented on taVNS device use at each visit as a safety measure. The device counter number will be recorded as a measure of adherence.
- Monitor for adverse events and tolerability: Parents/guardians will share a study log with investigators, which describes daily taVNS use, side effects, and any changes in heart rate.
At each virtual remote video visit, we will observe the participant while doing the intervention procedure, assess for nephrotic syndrome relapses, and monitor for any adverse events.
Part 3 - Follow Up Period - 26 weeks: At the completion of the randomized period, participants will be followed for an additional 26 weeks to assess clinical status. For those who stop the intervention, study visits will occur in-person during regularly scheduled clinical visits or via telehealth visit every 8 weeks, whichever is sooner. Participants will be assessed for the number of nephrotic syndrome relapses and home urine protein logs will be reviewed. First morning UPC will be recorded. All participants will be given the option to receive the active taVNS treatment at the end of the randomized period. Unblinding of treatment assignment from the randomized phase will not occur prior to consent for open-label use. As open-label extension trials may introduce significant bias, data obtained from these participants will not be considered part of this research and no statistical analysis will be carried out. However, clinical status and safety will continue to be monitored. In person study visits will occur every 8 weeks for those continuing use of taVNS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double blind sham controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: trascutaneous auricular vagus nerve stimulationThe intensity setting for pulse amplitude will be adjusted to the participant's tolerance (if a sensation is felt) to a maximum level of 3. |
| Sham Group | Sham comparator | Device: Sham deviceThe sham device will be altered 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Steroid Resistant Nephrotic Syndrome- defined as lack of remission after 4 weeks of therapy of prednisolone/prednisone at standard dose1
- Age 3-17 years
- eGFR ≥30 ml/min/1.73 m2 (by modified Schwartz formula)
- MCD or FSGS diagnosis (per biopsy)
- Urine protein:creatinine (UPC) greater than 1.0
Key exclusion criteria (8 listed)
- Secondary causes of nephrotic syndrome (e.g. genetic, congenital, infectious)
- Steroid sensitive nephrotic syndrome
- History of genetic defects known to directly cause nephrotic syndrome (i.e., NPHS2 [podocin], NPHS1 [nephrin], PLCE1, WT1, or other known genetic cause)
- Any known inflammatory condition
- History of cardiac disease (arrhythmias, structural/functional abnormalities)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trascutaneous auricular vagus nerve stimulationAlso: Roscoe TENS 7000The device to be used is the Roscoe Medical TENS 7000, a commercially available handheld electrical pulse generator, and an ear clip to be placed at the left ear for stimulation. Custom-made ear clips with electrode gel will be placed near the entrance to the canal of the ear to provide stimulation to the auricular branch. The handheld electrical pulse generator will be programmed to deliver electrical stimulation pulses to the cymba concha stimulating the auricular branch of the vagus nerve. | Device | Intervention Group |
| Sham deviceAlso: Roscoe TENS 7000The device will appear to function but no electrical stimulation will be delivered. | Device | Sham Group |
Primary outcome
Success of Pilot Trial
Time frame: Baseline to 26 weeks
1. Unsuccessful: main study not practicable 1. None of the primary feasibility and tolerability benchmarks are met, or 2. One or more of the primary benchmarks are not met and there is low likelihood of reaching benchmarks even with protocol modifications or 3. Serious adverse events related to the treatment. 2. Probable Success: main study practicable with modifications to protocol. One or more of the primary benchmarks are not met, but there is a high likelihood that the benchmark can be met with protocol modifications. 3. Successful: main study practicable without modifications. All of the primary benchmarks are met.
14 secondary outcomes
Effect size for change in Change in quality of life (PedsQL)
Time frame: Baseline to 26 weeks
Effect size for change in urine protein:creatinine
Time frame: Baseline to 26 weeks
Effect size for change in lipid profile
Time frame: Baseline to 26 weeks
Effect size for change in proportion with at least a 30 percent reduction in UPC
Time frame: Baseline to 26 weeks
Recruitment rate
Time frame: Baseline to 26 weeks
Rate of completion of study
Time frame: Baseline to 26 weeks
Successful double-blinding
Time frame: Baseline to 26 weeks
Treatment adherence from home logs
Time frame: Baseline to 26 weeks
Adverse events
Time frame: Baseline to 26 weeks
Incidence of withdrawal due to adverse events
Time frame: Baseline to 26 weeks
Proof of Concept Decision Criteria
Time frame: Baseline to 26 weeks
Cytokines
Time frame: Baseline to 26 weeks
Anti-nephrin antibodies
Time frame: Baseline to 26 weeks
Whole blood monocyte stimulation test
Time frame: 0 hours, 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Derived from this study: PubMed 38724717Meliambro K, He JC, Campbell KN. Podocyte-targeted therapies - progress and future directions. Nat Rev Nephrol. 2024 Oct;20(10):643-658. doi: 10.1038/s41581-024-00843-z. Epub 2024 May 9.
- Individual participant dataSharing planned: Yes. IPD will be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trascutaneous auricular vagus nerve stimulation in people with Nephrotic Syndrome in Children and Minimal Change Disease, run by Northwell Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine B Sethna, MD, EdM (718-470-3491, csethna@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of Pilot Trial (time frame: Baseline to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05583942, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.