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Visualize Nociceptor Changes in Neuropathic Human

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy, Peripheral Neuropathy

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
harmonic generation (HGM) microscopic methods.
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Healthy subjects

peripheral neuropathy

diabetic neuropathy

chemotherapy induced neuropathy

Polydactyly

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

nerve ending structure measurement
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

Full Information

First Posted
March 28, 2017
Last Updated
October 12, 2017
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03112057
Brief Title
Visualize Nociceptor Changes in Neuropathic Human
Official Title
Visualize Nociceptor Changes in Neuropathic Human
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2017 (Anticipated)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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: 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. 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. 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 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy, Peripheral Neuropathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
Healthy subjects of different ages (20 persons), Interventions: harmonic generation microscopy
Arm Title
peripheral neuropathy
Arm Type
Experimental
Arm Description
the participant have symptoms and diagnosed with peripheral neuropathy (90 persons), Interventions:harmonic generation microscopy
Arm Title
diabetic neuropathy
Arm Type
Experimental
Arm Description
the participant have symptoms and diagnosed with diabetic neuropathy (20 persons), Interventions:harmonic generation microscopy
Arm Title
chemotherapy induced neuropathy
Arm Type
Experimental
Arm Description
before chemotherapy, during chemotherapy, after peripheral nerve lesions were cured (30 persons). Interventions:harmonic generation microscopy
Arm Title
Polydactyly
Arm Type
Experimental
Arm Description
Abandoned extra digit specimen of polydactyly(10 persons): the normal skin and nerve endings in extra digit: Interventions: harmonic generation microscopy
Intervention Type
Diagnostic Test
Intervention Name(s)
harmonic generation (HGM) microscopic methods.
Intervention Description
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
Primary Outcome Measure Information:
Title
nerve ending number measurement
Description
Use of harmonic generation (HGM) microscopic virtual biopsy methods to obtain 3D live images.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
nerve ending structure measurement
Description
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
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LIN Wen-ying, MD
Phone
0972652006
Email
ying434@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Ying LIN, MD

12. IPD Sharing Statement

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