Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06030297
Status:
RECRUITING
Last Update Posted:
2023-09-08
First Post:
2023-08-04
Brief Title:
Diode Laser as a Biomarker for Neuropathic Pain of Peripheral Origin
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Diode Laser as a Biomarker for Neuropathic Pain of Peripheral Origin
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DLss
Brief Summary:
The R61 will perform a four-part double-blind randomized crossover study transitioning from a pretreatment baseline phase to randomized treatment with either lidocaine or an identical placebo patch washout and alternate arm DLss measures will be obtained before and after each phase Twice daily report of pain using a visual analogue scale will track severity of ongoing spontaneous pain in participants The hybrid biomarker will distinguish between placebo and active treatment arms will significantly correlate with extent of neuropathic pain reduction during lidocaine but will not change during the placebo phase or no-treatment lead-in If preset GoNo-Go criteria are met the subsequent R33 validation will then compare lidocaine patch and placebo treatment in a blinded randomized parallel arm study
Detailed Description:
Pain caused by peripheral neuropathy is very common Understanding patient response to pain and its treatment is one of the biggest barriers to development of effective medicines to reduce neuropathic pain This project will develop and validate a non-invasive test that correlates with patients experience of pain caused by peripheral neuropathy a pain biomarker The biomarker device applies specialized light energy to skin on the top of the foot to selectively stimulate the nerve fibers in skin that sense and transmit pain The test will determine how much energy is necessary to cause a person to feel the stimulus or to first feel the pain of the stimulus Sensory threshold to the stimulus and transient enhancement of blood flow in the skin flare will be correlated with patient report of ongoing foot pain Use of the experimental device diagnostic testing and use of lidocaine have risks that are explained in this document but can include allergic reactions discomfort and temporary numbness
SUMMARY OF STUDY PROCEDURES This study is being conducted by Drs J Robinson Singleton in the Department of Neurology at the University of Utah and by Mikhail Nemenov PhD of Stanford University who developed the use of this technique for stimulating nerves in the skin Study 1 will correlate the biomarker with patients reported ongoing neuropathic foot You may also be asked to participate in the Study 2 in which change in the biomarker will be correlated longitudinally to change in pain experience in a brief randomized crossover trial of placebo or lidocaine patches applied to the top of the foot
Optimization of DLss Biomarker in Healthy Subjects Stanford
Healthy subjects will be screened to exclude neuropathy foot pain and diabetes then will have the DLss measures performed over several days The visit lasts about 3-4 hours
Study 1 biomarker correlation with ongoing pain Utah
This study consists of a single visit designed to evaluate possible neuropathy and assess its severity with history standardized brief exam and specialized testing All participants will then rate their ongoing foot pain and biomarker testing will be performed The entire visit will take 2-3 hours The purpose is to correlate the biomarker with patients reported ongoing neuropathic foot pain
People with peripheral neuropathy A total of 50 people will participate
Study 2 biomarker correlation with change in pain during lidocaine treatment Utah
Study 2 is designed to see if change in neuropathic pain from treatment with an effective pain reducing agent correlates with change in the biomarker Lidocaine a locally acting anesthetic will be applied to the top of the foot using a patch The study is structured as a 4 week blinded and randomized crossover treatment trial and will five consist of 5 brief weekly study visits once weekly over the 4 week study period Crossover means that you will receive both treatments for a week each Randomized means that the treatment you receive first placebo or Lidocaine patch will be chosen at random Blinded means that you will not be told whether the treatment you receive during the treatment weeks is placebo or Lidocaine The patches will look similar or identical Neither you nor the study coordinator will be able to tell the identity of the patches
Study Segments Each weekly segment of the study is proceeded and followed by a visit in sequence Each visit will include review of neuropathic pain and performance of QST and Biomarker Device assessment There are four segments
1 Baseline neuropathic pain evaluation Each participant will be screened in clinic then record daily pain severity for 7 days
2 Treatment period 1 After this baseline period each participant will be randomized to 7 days of treatment with a patch either lidocaine or placebo chosen by the study at random
3 A 7-day wash out period without treatment
4 Treatment period 2 Daily treatment with patch not received in the first treatment period
A total of 44 people with neuropathy and associated neuropathic pain will participate
SUMMARY OF STUDY PROCEDURES This study is being conducted by Drs J Robinson Singleton in the Department of Neurology at the University of Utah and by Mikhail Nemenov PhD of Stanford University who developed the use of this technique for stimulating nerves in the skin Study 1 will correlate the biomarker with patients reported ongoing neuropathic foot You may also be asked to participate in the Study 2 in which change in the biomarker will be correlated longitudinally to change in pain experience in a brief randomized crossover trial of placebo or lidocaine patches applied to the top of the foot
Optimization of DLss Biomarker in Healthy Subjects Stanford
Healthy subjects will be screened to exclude neuropathy foot pain and diabetes then will have the DLss measures performed over several days The visit lasts about 3-4 hours
Study 1 biomarker correlation with ongoing pain Utah
This study consists of a single visit designed to evaluate possible neuropathy and assess its severity with history standardized brief exam and specialized testing All participants will then rate their ongoing foot pain and biomarker testing will be performed The entire visit will take 2-3 hours The purpose is to correlate the biomarker with patients reported ongoing neuropathic foot pain
People with peripheral neuropathy A total of 50 people will participate
Study 2 biomarker correlation with change in pain during lidocaine treatment Utah
Study 2 is designed to see if change in neuropathic pain from treatment with an effective pain reducing agent correlates with change in the biomarker Lidocaine a locally acting anesthetic will be applied to the top of the foot using a patch The study is structured as a 4 week blinded and randomized crossover treatment trial and will five consist of 5 brief weekly study visits once weekly over the 4 week study period Crossover means that you will receive both treatments for a week each Randomized means that the treatment you receive first placebo or Lidocaine patch will be chosen at random Blinded means that you will not be told whether the treatment you receive during the treatment weeks is placebo or Lidocaine The patches will look similar or identical Neither you nor the study coordinator will be able to tell the identity of the patches
Study Segments Each weekly segment of the study is proceeded and followed by a visit in sequence Each visit will include review of neuropathic pain and performance of QST and Biomarker Device assessment There are four segments
1 Baseline neuropathic pain evaluation Each participant will be screened in clinic then record daily pain severity for 7 days
2 Treatment period 1 After this baseline period each participant will be randomized to 7 days of treatment with a patch either lidocaine or placebo chosen by the study at random
3 A 7-day wash out period without treatment
4 Treatment period 2 Daily treatment with patch not received in the first treatment period
A total of 44 people with neuropathy and associated neuropathic pain will participate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None