Active — Not RecruitingNot Applicable

Electrical Nerve Block for Amputation Pain

United States607 participantsStarted 2014-10-09

Plain-language summary

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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Age ≥ 21 years old * Unilateral amputated leg ≥ 12 months * Chronic post amputation pain ≥ 6 months * Pain episodes typically lasting ≥ 60 minutes * Stable drug regimen ≥ 4 weeks * No changes to medications or prosthesis for 3-month primary study period Key Exclusion Criteria: * Implanted with an active implantable medical device (i.e. pacemaker) * Confounding source of pain that interferes with reporting of limb pain * Uncontrolled diabetes * Spasticity preventing full range of motion of involved side * Extremely short stump; sits on end * Untreated psychological condition (i.e. borderline personality) * Condition requiring MRI studies or diathermy after device implant * Life expectancy of less than 24 months * Progressive neurological disease (i.e. multiple sclerosis) * Subjects with active local or systemic infection or immunocompromised

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline

Timeframe: Randomized Testing Window (Month-1 to Month-3 post implant, 2 Month duration)

Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events

Timeframe: From screening injection visit through 3 months post implant

Trial details

NCT IDNCT02221934

SponsorNeuros Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-31

Results submitted2023-06-27

View on ClinicalTrials.gov More Post-Amputation Pain trials