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 range21 Years

SexALL

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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

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