Visualize Nociceptor Changes in Neuropathic Human

NCT03112057 | Unknown

• 1 other identifier: 201610037DINC
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this experiment is to establish a solid medical foundation for the successful development of non-invasive harmonic generation (HGM) microscopic slicing methods. The purpose of this new technology platform is to directly observe the nerve endings of nociceptors To enhance understanding of how neuropathies occur, persistence, and ease. This technique will assist in the diagnosis and prognosis of patients with neuralgia.

Conditions

Chemotherapy-induced Peripheral Neuropathy; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• nerve ending number measurement

  Use of harmonic generation (HGM) microscopic virtual biopsy methods to obtain 3D live images.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• nerve ending structure measurement

  through study completion, an average of 1 year

Study Arms (5)

Healthy subjects

EXPERIMENTAL

Healthy subjects of different ages (20 persons), Interventions: harmonic generation microscopy

Diagnostic Test: harmonic generation (HGM) microscopic methods.

peripheral neuropathy

EXPERIMENTAL

the participant have symptoms and diagnosed with peripheral neuropathy (90 persons), Interventions:harmonic generation microscopy

Diagnostic Test: harmonic generation (HGM) microscopic methods.

diabetic neuropathy

EXPERIMENTAL

the participant have symptoms and diagnosed with diabetic neuropathy (20 persons), Interventions:harmonic generation microscopy

Diagnostic Test: harmonic generation (HGM) microscopic methods.

chemotherapy induced neuropathy

EXPERIMENTAL

before chemotherapy, during chemotherapy, after peripheral nerve lesions were cured (30 persons). Interventions:harmonic generation microscopy

Diagnostic Test: harmonic generation (HGM) microscopic methods.

Polydactyly

EXPERIMENTAL

Abandoned extra digit specimen of polydactyly(10 persons): the normal skin and nerve endings in extra digit: Interventions: harmonic generation microscopy

Diagnostic Test: harmonic generation (HGM) microscopic methods.

Interventions

harmonic generation (HGM) microscopic methods. DIAGNOSTIC_TEST

a frequency-dependent optical microscopy system with a near-infrared light source with a wavelength of 1230 nm was used to detect the diseased site and normal skin.Use erbium-Jacob (Er-YAG) laser exfoliation. the participants need to lie down, wear goggles. The lens sucker device to help fix the skin examination site. Based on the experience of the past 118 subjects, the participants did not discomfort. The total time of the laser irradiation on the same skin is no more than 30 minutes, the maximum laser power is no more than 0.15 watts, irradiation in the skin of the total energy of the laser does not exceed 270 joules. After the experiment, the investigators immediately check the skin for the participants

Healthy subjects; Polydactyly; chemotherapy induced neuropathy; diabetic neuropathy; peripheral neuropathy

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects of different ages
• abandoned extra digit specimen in polydactyly
• diagnosed with peripheral neuropathy
• diabetic neuropathy patients have been removed after the completion of clinical diagnosis of the specimen, And then the skin slices of the nerve endings of the optical image observation
• because of chemotherapy during chemotherapy, is expected to have peripheral neuropathy: before the occurrence of peripheral neuropathy , after cured peripheral nerve lesions

You may not qualify if:

• systemic infection or have been infected with the site by the physician assessment is not suitable for examination.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

LIN Wen-ying, MD

CONTACT

0972652006; ying434@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 13, 2017
• Study Start: October 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2021
• Last Updated: October 16, 2017

Record last verified: 2017-03

Locations

TW (1)