Neurologic FindingsNCT05547685
Methylene Blue Intra-vital Nerve Staining
A study testing Methylene blue intradermal injection in people with Neurologic Findings, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurologic Findings
- What is being tested?
- Methylene blue intradermal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Apr 2020to 17 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteers
Who cannot join
- used serotonin agonist medication
Trial locations and contacts
1 site in 1 country.
wen-ying Lin contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hosipital
Taipei, 100
Wen-ying Lin, 0972652006, ying434@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Neurologic Findings
- Being tested
- Methylene blue intradermal injection
- Medical subject headings
- Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene blue intradermal injectionDiagnostic test
Methylene blue intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| Methylene blue intradermal injection | Experimental | Methylene blue intradermal injection Receives: Diagnostic Test: Methylene blue intradermal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
intravital staining
injected 10 μL of 0.03% methylene blue intradermally then calculate nerve fiber image
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start10 Apr 2020
- Primary completion17 Oct 2022 (estimated)
- Study completion17 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic FindingsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547685
- Sponsor's protocol ID
- 201904083MINA
- Status last verified
- Jan 2022
- First submitted
- 30 Aug 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmonic Generation Microscopy Observation of Intradermal Injection Nerve Fibers by Methylene Blue Intra-vital Staining
- ClinicalTrials.gov ID
- NCT05547685
- Acronym / sponsor ID
- 201904083MINA
- Conditions
- Neurologic Findings
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 17 Oct 2022 (estimated)
- Study completion
- 17 Oct 2022 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylene blue intradermal injection | Experimental | Diagnostic Test: Methylene blue intradermal injectionMethylene blue intradermal injection |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy Volunteers
Key exclusion criteria (1 listed)
- used serotonin agonist medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene blue intradermal injectionMethylene blue intradermal injection | Diagnostic test | Methylene blue intradermal injection |
Primary outcome
intravital staining
Time frame: 12 months
injected 10 μL of 0.03% methylene blue intradermally then calculate nerve fiber image
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wen-ying Lin contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylene blue intradermal injection in people with Neurologic Findings, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Zen Sun (0223123456 ext. 65522, wzsun@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intravital staining (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.