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Axon Therapy + CMM for Ilioinguinal Neuralgia
N/A
Waitlist Available
Research Sponsored by NeuraLace Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30- and 90-days post-treatment
Summary
This trial tests whether Axon Therapy combined with regular medical care can reduce nerve pain in diabetic patients. The study involves patients with painful diabetic neuropathy. Axon Therapy might work by sending signals to the nerves to help lessen pain.
Eligible Conditions
- Ilioinguinal Neuralgia
- Nerve pain
- Diabetic Neuropathy
- Neuralgia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30- and 90-days post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30- and 90-days post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Comparison of the Proportion of Responders
Therapeutic procedure
Secondary study objectives
Pain
Daily Sleep Interference Scale (DSIS)
Anxiety
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Axon Therapy + CMMExperimental Treatment1 Intervention
Subjects will be consented, screened, and then undergo a 7-day baseline assessment period. Subjects will be asked to record pain, numbness, and sleep scores via a twice daily electronic diary. Subjects who meet inclusion criteria, including diary compliance, will undergo an in-clinic baseline evaluation (Day 1), be randomized, and start their treatments.
All subjects will return to the clinic for treatments as follows:
● Day 1 - 30: 6 treatments
* Week 1: 3 treatments
* Week 2-4: Weekly treatments
All subjects will return to the clinic for follow-up assessment at Day 30 (± 5 days). At the Day 30 visits subjects will be asked if they want to participate in Phase 2 of the study.
Group II: Sham + CMMPlacebo Group1 Intervention
Subjects will be consented, screened, and then undergo a 7-day baseline assessment period. Subjects will be asked to record pain, numbness, and sleep scores via a twice daily electronic diary. Subjects who meet inclusion criteria, including diary compliance, will undergo an in-clinic baseline evaluation (Day 1), be randomized, and start their treatments.
All subjects will return to the clinic for treatments as follows:
● Day 1 - 30: 6 treatments
* Week 1: 3 treatments
* Week 2-4: Weekly treatments
All subjects will return to the clinic for follow-up assessment at Day 30 (± 5 days). At the Day 30 visits subjects will be asked if they want to participate in Phase 2 of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axon Therapy and CMM
2022
N/A
~100
Find a Location
Who is running the clinical trial?
NeuraLace Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
75 Total Patients Enrolled
Joe MilkovitsStudy DirectorNeuraLace Medical
1 Previous Clinical Trials
61 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been experiencing pain from diabetic neuropathy in your lower limbs for at least three months according to your medical records.You have skin conditions in the same area as your nerve pain that might make it difficult to accurately evaluate your pain.You have any other condition that may cause similar symptoms to peripheral diabetic neuropathy (PDN), like tarsal tunnel syndrome, sciatica, bunions, ischemic claudication, or foot or ankle arthritis.You have a progressive neurological disease like multiple sclerosis or a severe spinal condition.You have other types of pain that could make it difficult to assess or evaluate your specific nerve-related pain.The researcher thinks you might be at risk of hurting yourself or thinking about suicide.You have already tried another implantable device for the same health problem, but it didn't work.You have significant pain rated as 5 or higher on a pain scale.You are willing and able to comply with the study protocol.You are a male or female of any race or ethnicity who is 18-75 years of age.You have nerve pain caused by conditions like shingles, HIV, or trigeminal neuralgia. Your nerve pain is not from a spinal cord injury.You have ongoing or recurring pain that is more than just mild, and it may make it hard for you to accurately describe your pain during the study.You have other serious medical or mental health conditions, or abnormal lab results, or any other factors that could make participating in the study risky or affect the results.You experience pain in a body part that is missing or no longer there.You have metal objects or fragments in your body.You have been actively using drugs or alcohol in the past year.You must be literate in English to fill out the study questionnaires.
Research Study Groups:
This trial has the following groups:- Group 1: Axon Therapy + CMM
- Group 2: Sham + CMM
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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