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Trial record 4 of 119 for:    "Neuromuscular Disease" | "Lidocaine"

Autofluorescent Flavoprotein Imaging of Intraepidermal Nerve Fibers: a Pilot Study

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ClinicalTrials.gov Identifier: NCT02537951
Recruitment Status : Completed
First Posted : September 2, 2015
Results First Posted : June 3, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Joost LM Jongen, Erasmus Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Small Fiber Neuropathy
Interventions Device: AFI microscope
Device: negative control 1: lidocaine/prilocaine
Device: negative control 2: 8% capsaicin
Enrollment 10
Recruitment Details  
Pre-assignment Details

all 10 healthy volunteers underwent 3 experiments, all 10 have completed these experiments:

  1. AFI intensity measurements
  2. lidocaine/prilocaine creme, one hour later followed by AFI intensity measurements
  3. capsaicin patch (2 hours after lidocaine/prilocaine creme), one week later followed by AFI intensity measurements
Arm/Group Title 10 Healthy Volunteers
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10 healthy volunteers underwent three procedures, always in the same order:

  1. baseline AFI measurements
  2. application of lidocaine/prilocaine creme, 1 hour later followed by AFI measurements
  3. application of capsaicin patches, 1 week later followed by AFI measurements
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title AFI Intensity in Healthy Volunteers
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10 healthy volunteers, on whose 3rd fingertips AFI intensity is measured through an AFI microscope

AFI microscope: measurement of AFI intensities following increasing nociceptive stimulus intensities

After AFI intensity measurements, the same experiment will be repeated one hour after application of lidocaine/prilocaine creme

After the negative control experiment using lidocaine/prilocaine creme, AFI intensity measurements will be repeated one week after application of a capsaicin 8% patch (second negative control experiment)

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
25
(20 to 30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
0
   0.0%
Male
10
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Netherlands Number Analyzed 10 participants
10
 100.0%
1.Primary Outcome
Title AFI-intensity After Nociceptive Stimulation
Hide Description AFI-intensity (delta F/F) at the 3rd fingertip, directly after application of grading nociceptive stimuli
Time Frame Day 1, T=0h (AFI measurements), Day 1, T=6h (AFI measurements after lidocaine/prilocaine), Day 7 (AFI measurements after capsaicin)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AFI Intensity in Healthy Volunteers Negative Control 1: Lidocaine/Prilocaine Negative Control 2: 8% Capsaicin
Hide Arm/Group Description:

10 healthy volunteers, on whose 3rd fingertips AFI intensity is measured through an AFI microscope

AFI microscope: measurement of AFI intensities following increasing nociceptive stimulus intensities

10 healthy volunteers, on whose 3rd fingertips AFI intensity is measured through an AFI microscope, 1hour after application of lidocaine/prilocaine creme (negative control 1)

negative control 1: lidocaine/prilocaine: measurement of AFI intensities following lidocaine/prilocaine cream

-10 healthy volunteers, on whose 3rd fingertips AFI intensity is measured through an AFI microscope, 1week after application of an 8% capsaicin patch (negative control 2)

negative control 2: 8% capsaicin: measurement of AFI intensities following 8% capsaicin patch

Overall Number of Participants Analyzed 10 10 10
Mean (Standard Error)
Unit of Measure: unitless
0.60  (0.25) 0.25  (0.25) 0.50  (0.50)
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AFI Intensity in Healthy Volunteers Negative Control 1: Lidocaine/Prilocaine Negative Control 2: 8% Capsaicin
Hide Arm/Group Description 10 healthy volunteers-AFI intensity measurements 10 healthy volunteers-lidocaine/prilocaine creme, one hour lat 10 healthy volunteers-capsaicin patch (2 hours after lidocaine
All-Cause Mortality
AFI Intensity in Healthy Volunteers Negative Control 1: Lidocaine/Prilocaine Negative Control 2: 8% Capsaicin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
AFI Intensity in Healthy Volunteers Negative Control 1: Lidocaine/Prilocaine Negative Control 2: 8% Capsaicin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AFI Intensity in Healthy Volunteers Negative Control 1: Lidocaine/Prilocaine Negative Control 2: 8% Capsaicin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joost L.M. Jongen
Organization: Erasmus MC
Phone: +31107041415
EMail: j.jongen@erasmusmc.nl
Layout table for additonal information
Responsible Party: Joost LM Jongen, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02537951     History of Changes
Other Study ID Numbers: NL49568.078.14
First Submitted: August 22, 2015
First Posted: September 2, 2015
Results First Submitted: January 30, 2018
Results First Posted: June 3, 2019
Last Update Posted: June 11, 2019