Visualize Nociceptor Changes in Neuropathic Human

October 12, 2017 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201610037DINC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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