Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation (REGAIN)

Epineuron Technologies

Status: Enrolling

Conditions: Nerve Injury

Treatments: Device: Sham Temporary Peripheral Nerve Stimulation System; Device: Temporary Peripheral Nerve Stimulation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05721261

EPNR-CIP-002

Details and patient eligibility

About

A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Peripheral nerve injury

Exclusion criteria

• Peripheral neuropathy
• Patients with any active implanted device

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

Active treatment

Experimental group

Treatment:

Device: Temporary Peripheral Nerve Stimulation System

Sham treatment

Sham Comparator group

Treatment:

Device: Sham Temporary Peripheral Nerve Stimulation System