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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 1 March 2021
Main ID:  NCT03772717
Date of registration: 10/12/2018
Prospective Registration: Yes
Primary sponsor: Emory University
Public title: Non-invasive Vagus Nerve Stimulation (nVNS) in Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Scientific title: Non-invasive Vagus Nerve Stimulation (nVNS) in Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Date of first enrolment: April 1, 2021
Target sample size: 10
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT03772717
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Sumit Verma, MD
Address: 
Telephone: 404-785-9893
Email: sumit.verma@emory.edu
Affiliation: 
Name:     Sumit Verma, MD
Address: 
Telephone: 404-785-9893
Email: sumit.verma@emory.edu
Affiliation: 
Name:     Sumit Verma, MD
Address: 
Telephone:
Email:
Affiliation:  Emory University
Name:     Robert Butera, PhD
Address: 
Telephone:
Email:
Affiliation:  Georgia Institute of Technology
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of CIDP based upon clinical/electrophysiological criteria

- Patient should be on treatment for CIDP including IVIG and Steroids

Exclusion Criteria:

- Patients will be excluded from the study if they have inherited polyneuropathy, such
as Charcot Tooth Marie disease.



Age minimum: 5 Years
Age maximum: 21 Years
Gender: All
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyneuropathy
Intervention(s)
Device: Vital EMS+
Drug: Standard of Care
Primary Outcome(s)
Change in hand grip strength [Time Frame: Baseline, Month 6, Month 12, Month 18, Month 24]
Change in nerve conduction study conduction amplitude [Time Frame: Baseline, Month 12, Month 24]
Change in nerve conduction study conduction velocity [Time Frame: Baseline, Month 12, Month 24]
Change in nerve conduction study distal latency [Time Frame: Baseline, Month 12, Month 24]
Change in nerve conduction study F wave latency [Time Frame: Baseline, Month 12, Month 24]
Change in Rasch-built Overall Disability Scale (R-ODS) for CIDP [Time Frame: Baseline, Month 6, Month 12, Month 18, Month 24]
Secondary Outcome(s)
Change in hepatocyte growth factor (HGF) [Time Frame: Baseline, Month 6, Month 12, Month 18, Month 24]
Change in interleukin (IL)-1ß [Time Frame: Baseline, Month 6, Month 12, Month 18, Month 24]
Change in macrophage inflammatory protein (MIP)-1ß [Time Frame: Baseline, Month 6, Month 12, Month 18, Month 24]
Change in tumor necrosis factor (TNF)-a [Time Frame: Baseline, Month 6, Month 12, Month 18, Month 24]
Secondary ID(s)
IRB00098592
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Georgia Institute of Technology
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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