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

• Status: Not yet recruiting
• Trial end date: 2020-10-01
• Target enrollment: 10
• Participant gender: All

Summary

This study will be conducted at Children's Healthcare of Atlanta, in Atlanta, Georgia for a total duration of 24 months. The electrical neuromuscular stimulation device used in this study is the Vital EMS+, which has been used in multiple previous clinical studies for modulation of pain and has received FDA approval. A total of 10 study participants will be randomly assigned to one of two groups in the study: 5 will receive the standard of care treatment plus electrical neuromuscular stimulation and 5 will receive standard of care and devices that do not deliver electrical stimulation (sham device). Participants will be requested to deliver nVNS two times per day, at least five days per week in their home, for two years.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Georgia Institute of Technology
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

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.