Electrical Nerve Block for Phantom Limb Pain

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

607 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation 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 data supports the effectiveness of the Altius System treatment for phantom limb pain?

Research shows that electrical stimulation, similar to the Altius System, has provided excellent or partial relief of phantom limb pain in patients. Additionally, peripheral nerve stimulation, which is a component of the Altius System, has been shown to significantly reduce phantom limb pain in some patients. ^{1 2 3 4 5}

Is the Electrical Nerve Block treatment safe for humans?

The Altius System, which uses high-frequency nerve block therapy, is being studied for safety in a clinical trial for post-amputation pain. While specific safety data is not detailed, the trial is designed to meet FDA approval standards, suggesting a focus on ensuring safety. ^{1 4 6 7 8}

How does the Altius System treatment for phantom limb pain differ from other treatments?

The Altius System is unique because it uses a high-frequency nerve block (HFNB) delivered through a cuff electrode on the peripheral nerve and an implantable pulse generator, offering a novel approach compared to traditional methods like short-term nerve blocks or electrical stimulation, which may not provide long-term relief. ^{1 2 4 9 10}

Research Team

Leonardo Kapural, MD

Principal Investigator

Center for Clinical Research, Winston-Salem NC

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Can neural blocks prevent phantom limb pain? [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Phantom limb pain treated by electrical stimulation. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Published treatments of phantom limb pain. [2006]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation enables somatosensory feedback while suppressing phantom limb pain in transradial amputees. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Patient-centered results from a multicenter study of continuous peripheral nerve blocks and postamputation phantom and residual limb pain: secondary outcomes from a randomized, clinical trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Perioperative Anesthetic Techniques to Reduce Surgical Morbidity After Amputation. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Image-Guided Cryoablation for the Treatment of Phantom Limb Pain in Amputees: A Pilot Study. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Ultrasound-guided posterior approach to brachial plexus for the treatment of upper phantom limb syndrome. [2022]

10. Denmark pubmed.ncbi.nlm.nih.gov

[Sciatic nerve block performed with nerve stimulation technique in an amputee--a case study]. [2008]