Feasibility Study of a Temporary Peripheral Nerve Stimulator

Epineuron Technologies

Status: Completed

Conditions: Nerve Injury

Treatments: Device: Temporary Peripheral Nerve Stimulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT04732936

EPNR-CIP-001

Details and patient eligibility

About

A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are between 18-65 years old
• Have a Sunderland II-V peripheral nerve injury of the upper extremity
• Are receiving surgery within 14 days of injury

Exclusion criteria

• Nerve plexus injuries (e.g. brachial plexus)
• Nerve gap requiring graft/conduit, or extreme joint flexion
• Polyneuropathies
• Cognitive impairment and non-English-speaking
• Uncontrolled diabetes
• Surgical intervention > 14 days of injury
• Co-enrollment in another clinical trial
• Pregnant women

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

Device Usability

Experimental group

Description:

Device usability and safety will be evaluated.

Treatment:

Device: Temporary Peripheral Nerve Stimulator

Preliminary Efficacy

Experimental group

Description:

Preliminary treatment efficacy will be evaluated.

Treatment:

Device: Temporary Peripheral Nerve Stimulator