TerminatedNot Applicable

Non-invasive Vagus Nerve Stimulation (nVNS) in Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Stopped: This study was terminated due to difficulties with enrollment and poor adherence to the study intervention among participants.

United States2 participantsStarted 2022-02-22

Plain-language summary

Participants will be requested to deliver non-invasive vagus nerve stimulation (nVNS) two times per day, at least five days per week. Participants will be followed for two years with nVNS as an adjunctive therapy to the standard of care therapy for chronic inflammatory demyelinating polyneuropathy (CIDP).

Who can participate

Age range

5 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Diagnosis of CIDP based upon clinical/electrophysiological criteria * On treatment for CIDP including IVIG and/ or steroids/plasma exchange Exclusion criteria: * Inherited polyneuropathy, such as Charcot Tooth Marie disease * Abnormal baseline EKG, heart disease, epilepsy, pregnancy, multiple sclerosis and diabetes mellitus

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Nerve Conduction Study - Distal Latency

Timeframe: Baseline, Month 12, Month 24

Nerve Conduction Study - F Wave Latency

Timeframe: Baseline, Month 12, Month 24

Nerve Conduction Study - Conduction Velocity

Timeframe: Baseline, Month 12, Month 24

Nerve Conduction Study - Conduction Amplitude

Timeframe: Baseline, Month 12, Month 24

Hand Grip Strength

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24

Rasch-built Overall Disability Scale (R-ODS) for CIDP Score

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24

Trial details

NCT IDNCT03772717

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-30

Results submitted2023-06-22

View on ClinicalTrials.gov More Chronic Inflammatory Demyelinating Polyneuropathy trials

Plain-language summary

Who can participate

Age range

5 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Nerve Conduction Study - Distal Latency

Timeframe: Baseline, Month 12, Month 24

Nerve Conduction Study - F Wave Latency

Timeframe: Baseline, Month 12, Month 24

Nerve Conduction Study - Conduction Velocity

Timeframe: Baseline, Month 12, Month 24

Nerve Conduction Study - Conduction Amplitude

Timeframe: Baseline, Month 12, Month 24

Hand Grip Strength

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24

Rasch-built Overall Disability Scale (R-ODS) for CIDP Score

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24