Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial

Epineuron Technologies

Status: Enrolling

Conditions: Neuropathy;Peripheral

Treatments: Device: Temporary Peripheral Nerve Stimulation System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05980767

EPNR-CIP-003

Details and patient eligibility

About

A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ulnar neuropathy at the elbow

Exclusion criteria

• Peripheral neuropathy outside of nerve of interest
• Patients with any active implanted device

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Experimental Intervention

Active Comparator group

Description:

Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation.

Treatment:

Device: Temporary Peripheral Nerve Stimulation System

Control

No Intervention group

Description:

Standard of care only.