Visualize Nociceptor Changes in Neuropathic Human

• ClinicalTrials.gov Identifier: NCT03112057
• Recruitment Status: Unknown
• First Posted: April 13, 2017
• Last Update Posted: October 16, 2017
• Sponsor: National Taiwan University Hospital
• Information provided by (Responsible Party): National Taiwan University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chemotherapy-induced Peripheral Neuropathy; Peripheral Neuropathy	Diagnostic Test: harmonic generation (HGM) microscopic methods.	Not Applicable

Detailed Description:

This study will be the skin tissue for the virtual slice object, the study intends to the following research:

The number of people enrolled in the Court is 170.

Between 20 and 90 years old, meet the following conditions, suitable for participation in this test:

1. Healthy subjects of different ages (20 persons): to study the optical imaging of the skin and nerve endings: the control of healthy subjects and peripheral neuropathy patients skin observed by the optical images of the shoots.
2. Abandoned extra digit specimen of polydactyly(10 persons): to study the optical imaging of the normal skin and nerve endings in extra digit : collect abandoned digit specimen after surgical removal in polydactyly.
3. has been diagnosed with peripheral neuropathy (90 persons):to study the diagnosis of peripheral neuropathy of the skin nerve endings of the optical image observation and quantitative sensory nerve examination
4. clinically must be diagnosed by the skin slices of 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 (20 persons):study the technical observation of diabetic patients with skin sections of the nerve endings of the optical image observation: the clinical must be skin slices for the diagnosis of diabetic neuropathy, patients has been taken out after the completion of clinical diagnosis, and then the skin slices of the nerve endings of the light learning image observation.
5. because of chemotherapy during chemotherapy, is expected to have peripheral neuropathy: before the occurrence of peripheral neuropathy , Peripheral nerve lesions were cured after subcutaneous nerve optical observation (30 persons):for different periods of peripheral neuropathy subcutaneous nerve optical observation: in the peripheral neuropathy occurred before the occurrence of peripheral neuropathic symptoms, peripheral neuropathy after cure for subcutaneous nerve optical observation.

This test can not be attended if:

Those who suffer from systemic infection or have been infected with the site by the physician assessment is not suitable for examination.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 170 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Visualize Nociceptor Changes in Neuropathic Human
• Estimated Study Start Date: October 2017
• Estimated Primary Completion Date: December 2017
• Estimated Study Completion Date: December 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Healthy subjects; Healthy subjects of different ages (20 persons), Interventions: harmonic generation microscopy	Diagnostic Test: harmonic generation (HGM) microscopic methods.; 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
Experimental: peripheral neuropathy; the participant have symptoms and diagnosed with peripheral neuropathy (90 persons), Interventions:harmonic generation microscopy	Diagnostic Test: harmonic generation (HGM) microscopic methods.; 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
Experimental: diabetic neuropathy; the participant have symptoms and diagnosed with diabetic neuropathy (20 persons), Interventions:harmonic generation microscopy	Diagnostic Test: harmonic generation (HGM) microscopic methods.; 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
Experimental: chemotherapy induced neuropathy; before chemotherapy, during chemotherapy, after peripheral nerve lesions were cured (30 persons). Interventions:harmonic generation microscopy	Diagnostic Test: harmonic generation (HGM) microscopic methods.; 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
Experimental: Polydactyly; 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.; 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

Outcome Measures

Primary Outcome Measures :

1. nerve ending number measurement [ Time Frame: through study completion, an average of 1 year ]
   Use of harmonic generation (HGM) microscopic virtual biopsy methods to obtain 3D live images.

Secondary Outcome Measures :

1. nerve ending structure measurement [ Time Frame: through study completion, an average of 1 year ]
   Quantify the molecules on the image, the biological characteristics of tissue nerve cells have a comprehensive understanding, and will try to establish the human subcutaneous nerve optical observation method

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: LIN Wen-ying, MD; 0972652006; ying434@gmail.com

Locations

Taiwan

National Taiwan University Hospital

Taipei, Taiwan, 100

Contact: Wen-Ying LIN, MD

Sponsors and Collaborators

National Taiwan University Hospital

More Information

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT03112057
• Other Study ID Numbers: 201610037DINC
• First Posted: April 13, 2017
• Last Update Posted: October 16, 2017
• Last Verified: March 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases