Methylene Blue Intra-vital Nerve Staining
Primary Purpose
Neurologic Findings
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Methylene blue intradermal injection
Sponsored by
About this trial
This is an interventional diagnostic trial for Neurologic Findings
Eligibility Criteria
Inclusion Criteria:
- Healthy Volunteers
Exclusion Criteria:
- used serotonin agonist medication
Sites / Locations
- National Taiwan University HosipitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Methylene blue intradermal injection
Arm Description
Methylene blue intradermal injection
Outcomes
Primary Outcome Measures
intravital staining
injected 10 μL of 0.03% methylene blue intradermally then calculate nerve fiber image
Secondary Outcome Measures
Full Information
NCT ID
NCT05547685
First Posted
August 30, 2020
Last Updated
September 19, 2022
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05547685
Brief Title
Methylene Blue Intra-vital Nerve Staining
Official Title
Harmonic Generation Microscopy Observation of Intradermal Injection Nerve Fibers by Methylene Blue Intra-vital Staining
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2020 (Actual)
Primary Completion Date
October 17, 2022 (Anticipated)
Study Completion Date
October 17, 2022 (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
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurologic Findings
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Methylene blue intradermal injection
Arm Type
Experimental
Arm Description
Methylene blue intradermal injection
Intervention Type
Diagnostic Test
Intervention Name(s)
Methylene blue intradermal injection
Intervention Description
Methylene blue intradermal injection
Primary Outcome Measure Information:
Title
intravital staining
Description
injected 10 μL of 0.03% methylene blue intradermally then calculate nerve fiber image
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Volunteers
Exclusion Criteria:
used serotonin agonist medication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Zen Sun
Phone
0223123456
Ext
65522
Email
wzsun@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
wen-ying Lin
Phone
0223123456
Facility Information:
Facility Name
National Taiwan University Hosipital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-ying Lin
Phone
0972652006
Email
ying434@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Methylene Blue Intra-vital Nerve Staining
We'll reach out to this number within 24 hrs