Methylene Blue Intra-vital Nerve Staining

Harmonic Generation Microscopy Observation of Intradermal Injection Nerve Fibers by Methylene Blue Intra-vital Staining

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.

Study Overview

• Status: Recruiting
• Conditions: Neurologic Findings
• Intervention / Treatment: Diagnostic test: Methylene blue intradermal injection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei-Zen Sun; Phone Number: 65522 0223123456; Email: wzsun@ntu.edu.tw
• Study Contact Backup: Name: wen-ying Lin; Phone Number: 0223123456

Study Locations

• Taiwan
  • Taipei City, Taiwan, 100
    • Recruiting
    • National Taiwan University Hosipital
    • Contact: Wen-ying Lin; Phone Number: 0972652006; Email: ying434@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy Volunteers

Exclusion Criteria:

• used serotonin agonist medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Methylene blue intradermal injection	Diagnostic test: Methylene blue intradermal injection; Methylene blue intradermal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intravital staining	injected 10 μL of 0.03% methylene blue intradermally then calculate nerve fiber image	12 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2020
• Primary Completion (Anticipated): October 17, 2022
• Study Completion (Anticipated): October 17, 2022

Study Registration Dates

• First Submitted: August 30, 2020
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Methylene Blue
• Other Study ID Numbers: 201904083MINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No