NCT05614128

Validation of Cutaneous Nerve Demyelination in Diagnosis and Treatment of CIDP

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to learn about chronic inflammatory demyelinating polyneuropathy. The main question the investigators would like to answer is 1) can skin biopsy identify demyelination better than nerve conduction studies (electrical tests of the nerves)? and 2) how do nerves improve after treatment in CIDP? Participants will be asked to undergo skin biopsy of the finger at baseline and at 3 months and 6 months after treatment with IVIG (which is the FDA approved treatment for CIDP).

Detailed description

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is an autoimmune disorder that can cause severe weakness and numbness, difficulty walking if untreated. CIDP is a disorder where the myelin or outside covering of the nerves which protect nerves and speed conduction are damaged by the immune system. The typical way CIDP is diagnosed is by performing electrical stimulation of the nerves (nerve conduction study or NCS) which may not be very accurate in identifying CIDP. The investigators also are not clear on how CIDP nerve impairment improves with treatment after IVIg, which is the recommended treatment. This study uses skin biopsy of the finger to look at the nerves and see if abnormalities of myelin such as segmental demyelination (loss of myelin along the course of the nerve) can be detected under microscope. The investigators will repeat the skin biopsy during treatment with IVIg (brand Privigen which is FDA approved for CIDP) to determine how IVIg improves nerves during treatment. The investigators hope this study will provide both better ways to diagnose patients with CIDP as well as inform doctors on how CIDP can improve with treatment. The investigators are recruiting patients newly diagnosed or within 6 months of diagnosis to study the use of skin biopsies in diagnosis of CIDP. The investigators are also repeating skin biopsies at 3 months and 6 months to measure improvement in nerve demyelination.

Conditions

• CIDP

Interventions

Type	Name	Description
OTHER	IVIg	Patients will be treated with IVIg as recommended by expert guidelines for treatment of CIDP under care of their primary neurologist. This will not be provided by the study.

Timeline

• Start date: 2023-02-28
• Primary completion: 2024-09-19
• Completion: 2024-09-19
• First posted: 2022-11-14
• Last updated: 2025-06-05

Locations

1 site across 1 country: United States