Electrical Nerve Block for Phantom Limb Pain

Not currently recruiting at 22 trial locations

Overseen By Gita Ghadimi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neuros Medical, Inc.

Disqualifiers: Uncontrolled diabetes, Untreated psychological condition, Progressive neurological disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Altius System, an electrical nerve block device, to determine its safety and effectiveness in treating phantom limb pain after amputation. The study consists of two parts: one where the Altius delivers a therapeutic nerve block and another where it delivers a non-therapeutic signal to the nerve. It suits individuals who have had one leg amputated for at least a year and experience ongoing pain episodes lasting an hour or more. Participants should not have devices like pacemakers or other conditions that might interfere with the trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially find relief from phantom limb pain.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial requires that you maintain a stable drug regimen for at least 4 weeks before starting and make no changes to your medications during the 3-month primary study period.

What prior data suggests that the Altius System is safe for treating phantom limb pain?

Research has shown that the Altius System, which blocks nerve signals, may help treat pain after amputation. Studies have found that it can significantly reduce pain for many patients.

Regarding safety, several studies suggest that the treatment is generally well-tolerated. For instance, one study found that most patients using the Altius System experienced significant pain relief without serious side effects. Another study monitored patients for 12 months and found no major safety issues related to the treatment.

These findings suggest that the Altius System is safe for many people, but discussing potential risks with a doctor before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Altius System because it offers a novel approach to managing phantom limb pain. Unlike traditional treatments, which often include medications like opioids or antidepressants, the Altius System uses a high-frequency bioelectric nerve block. This technique directly targets the affected nerves with electrical signals, which could provide more precise and immediate pain relief without the side effects associated with drugs. Additionally, this system is self-initiated by the patient, offering a level of autonomy and convenience not typically available in standard therapies.

What evidence suggests that the Altius System is effective for phantom limb pain?

Studies have shown promising results for the Altius System in treating phantom limb pain. In one study, patients reported an average pain reduction of 73% over a year, indicating long-lasting relief. Another study demonstrated a 33% pain decrease just 30 minutes after therapy began. In this trial, participants may receive the Test Treatment, where the Altius System delivers a high-frequency bioelectric nerve block to the nerve, or the Active Sham Control Treatment, which involves a non-therapeutic electrical signal. The device sends a high-frequency electrical signal to the nerve, blocking pain without causing harm. These findings highlight the potential of the Altius System to effectively manage pain for individuals who have had an amputation. ^{1 2 3 4 5}

Who Is on the Research Team?

Leonardo Kapural, MD

Principal Investigator

Center for Clinical Research, Winston-Salem NC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I had one leg amputated over a year ago.

I am 21 years old or older.

My pain episodes usually last an hour or more.

Exclusion Criteria

My spasticity stops me from moving fully.

I have an active infection or a weakened immune system.

You are not expected to live for more than 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Testing

Implantation of the Altius System and initial testing of the device

1 month

1 visit (in-person)

Randomized Testing Window

Participants receive either the high frequency bioelectric nerve block or a sham control treatment

2 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including pain reduction and quality of life assessments

12 months

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Altius System

Trial Overview 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.

How Is the Trial Designed?

Group I: Test Treatment Experimental Treatment 1 Intervention

Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius.

Group II: Active Sham Control Treatment Active Control 1 Intervention

Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius.

Who Is Running the Clinical Trial?

Neuros Medical, Inc.

Lead Sponsor

Trials

1

Recruited

610+

Published Research Related to This Trial

In a pilot study involving 21 patients with refractory phantom limb pain, image-guided percutaneous nerve cryoablation demonstrated a 100% technical success rate and was found to be a feasible and safe procedure.

Patients experienced significant reductions in pain intensity, from a mean score of 6.2 to 2.0, and improvements in disability scores, from 11.3 to 3.3, indicating that this treatment may be an effective option for managing phantom limb pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Image-Guided Cryoablation for the Treatment of Phantom Limb Pain in Amputees: A Pilot Study. Prologo, JD., Gilliland, CA., Miller, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11164212/

Primary 3-Month Outcomes of a Double-Blind Randomized ... The treatment efficacy was sustained for up to 12-months with an average pain reduction of 73%. These preliminary data provided the framework ...

2. neurosmedical.com neurosmedical.com/wp-content/uploads/2024/10/LB-0222-Rev-A-12-Month-Summary.pdf

QUEST STUDY 12-MONTH DATA SUMMARY1 Altius therapy delivered directly to the damaged peripheral nerve provided sustained, on-demand relief of acute PAP exacerbations, reduced opioid utilization, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1094715924006755

Long-Term Treatment of Chronic Postamputation Pain With ... In the present study, this conduction block produced an average approximately 33% reduction in pain within 30 minutes of initiating therapy, which increased to ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02221934

NCT02221934 | Electrical Nerve Block for Amputation Pain Use of this device may be associated with providing an effective, mechanism-based yet non-destructive, treatment for managing intractable limb pain in amputees.

5. clinicaltrial.be clinicaltrial.be/en/details/11678?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Electrical Nerve Block for Amputation Pain - Clinical Tri... Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline · Primary Safety Endpoint: Incidence of Reported and Adjudicated ...