← Back to Search

Electrical Nerve Block

Electrical Nerve Block for Phantom Limb Pain

N/A

Waitlist Available

Led By Leonardo Kapural, MD, PhD

Research Sponsored by Neuros Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unilateral amputated leg ≥ 12 months

Age ≥ 21 years old

Must not have

Spasticity preventing full range of motion of involved side

Subjects with active local or systemic infection or immunocompromised

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomized testing window (month-1 to month-3 post implant, 2 month duration)

Awards & highlights

No Placebo-Only Group

Summary

This trial is to see if a new pain treatment is safe and effective for people who have had an amputation.

Who is the study for?

This trial is for adults over 21 with chronic pain after leg amputation, lasting at least 6 months. Candidates must have had their limb amputated for over a year and be on a stable medication regimen without changes to medications or prosthesis planned during the study. Exclusions include those needing MRI post-implant, with active medical devices like pacemakers, untreated major psychological issues, life expectancy under two years, other major pain sources or conditions like uncontrolled diabetes.

What is being tested?

The trial is testing the Altius System's electrical nerve block to see if it safely and effectively reduces pain in patients who have undergone an amputation. Participants will receive this non-drug treatment aimed at managing long-term post-amputation pain.

What are the potential side effects?

Potential side effects of the Altius System may include discomfort at the site of application, skin irritation from electrodes, possible nerve damage if not properly administered, and muscle twitching due to electrical stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had one leg amputated over a year ago.

Select...

I am 21 years old or older.

Select...

My pain episodes usually last an hour or more.

Select...

I have had pain for over 6 months after an amputation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My spasticity stops me from moving fully.

Select...

I have an active infection or a weakened immune system.

Select...

My amputated limb has a very short remaining part.

Select...

My diabetes is not under control.

Select...

My neurological condition, like multiple sclerosis, is getting worse.

Select...

I have another source of pain that could affect my ability to report limb pain accurately.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomized testing window (month-1 to month-3 post implant, 2 month duration)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomized testing window (month-1 to month-3 post implant, 2 month duration)

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomized testing window (month-1 to month-3 post implant, 2 month duration) for reporting.