The application study of skin biopsy combined high-frequency neuro-ultrasound in the diagnosis of immune mediated peripheral neuropathy

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000036631

Enrollment

Unknown

Registered

2020-08-24

Start date

2020-11-01

Completion date

Unknown

Last updated

2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

immune mediated peripheral neuropathy

Interventions

Gold Standard:neuro-electrophysiological test combined nerve biopsy

Index test:high&#32

frequency&#32

combined&#32

skin&#32

biopsy

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.adults aged 18-85 years; 2.diagnosed as primary immune-mediated peripheral neuropathy(GBS or CIDP) vasculitic PPN or MGUS-PPN; 3.agreed to join the study.

Exclusion criteria

Exclusion criteria: 1.other causes of peripharal neuropathy except for immune-mediated; 2.with cervical or lumbar radiculopathy; 3.with severe cognitive or mental disorder; 4.with malignant tumor; 5.with severe diseases of other organs like heart disease, brain disease or infection; 6.with severe bleeding tendency; 7.with heart pacemaker; 8.attending other clinical trials.

Design outcomes

Primary

Measure	Time frame
ultrasound of peripahral nerve structure;Skin intraepidermal nerve density;Skin dermal nerve density;SEN, SPE, ACC, AUC of ROC;	—

Countries

China

Contacts

Public ContactJi-Hong Dong

Zhongshan Hospital, Fudan University

dong.jihong@zs-hospital.sh.cn+86 13681972962

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026