Electrical Nerve Block for Amputation Pain

Neuros Medical

Status: Active, not recruiting

Conditions: Residual Limb Pain; Phantom Limb Pain; Post-Amputation Pain; Stump Pain

Treatments: Device: Altius

Study type: Interventional

Funder types: Industry

Identifiers

NCT02221934

003-0001

QUEST Trial (Other Identifier)

Details and patient eligibility

About

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.

Full description

The Altius System is an implanted device designed to electrically block nerve signals and alleviate 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. In a given patient, the Altius System will be deemed effective if treatment results in 50% reduction of pain score for more than 50% of all pain episodes.

Enrollment: 607 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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607 participants in 2 patient groups

Test Treatment

Experimental group

Description:

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

Treatment:

Device: Altius

Active Sham Control Treatment

Active Comparator group

Description:

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

Treatment:

Device: Altius