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Methylene Blue Intra-vital Nerve Staining

NCT ID: NCT05547685

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-10

Study Completion Date

2022-10-17

Brief Summary

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In previous studies, we know methylene blue (MB) stains nerves, and oxidized MB has near-infrared (NIR) fluorescence for fluorescent observation. In this trial we using MB on human skin and combining MB and third-harmonic generation imaging (THG) to label cutaneous nerve fibers.

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Detailed Description

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Intravital images were obtained before injection and then taken at 0.5, 1, 1.5, 2, 2.5, and 3 h after intradermal 0.03% (0.3 mg/mL, 1500μM) MB (10mg/mL "Astar") injection using a 0.5-mL 29-gauge insulin syringe needle (Becton, Dickinson and Company, USA). The participant lay down and the skin was imaged 10 cm above the ankle in the lower leg and above the wrist in the middle forearm; three sites in each limb were randomly selected for each time point. SHG or THG captured MB signals with two-photon excitation microscope at the Molecular Biomedical Imaging Research Center of National Taiwan University.

Conditions

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Neurologic Findings

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Methylene blue intradermal injection

Methylene blue intradermal injection

Group Type EXPERIMENTAL

Methylene blue intradermal injection

Intervention Type DIAGNOSTIC_TEST

Methylene blue intradermal injection

Interventions

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Methylene blue intradermal injection

Methylene blue intradermal injection

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Healthy Volunteers

Exclusion Criteria

* used serotonin agonist medication
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hosipital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Wei-Zen Sun

Role: CONTACT

[email protected]
0223123456 ext. 65522

wen-ying Lin

Role: CONTACT

0223123456

Facility Contacts

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Wen-ying Lin

Role: primary

[email protected]
0972652006

Other Identifiers

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201904083MINA

Identifier Type: -

Identifier Source: org_study_id

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