NCT05884125

Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Checkpoint Surgical Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for peripheral nerve injury in arm. Participants will be randomized into one of two groups, treatment or control, with all participants receiving standard of care treatment for the nerve injury. The treatment group will also receive a single dose of the therapeutic stimulation during the surgical intervention for their nerve injury.

Detailed description

Preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery. This pilot study is investigating the use of a single dose of therapeutic electrical stimulation to promote nerve healing. The therapy is delivered as part of the surgical intervention to address peripheral nerve injury in the arm.

Conditions

• Nerve Injury
• Peripheral Nerve Injuries
• Peripheral Nerve Injury Upper Limb
• Nerve Palsy

Interventions

Type	Name	Description
DEVICE	Checkpoint BEST System	Single use medical device, consisting of electric stimulator and intraoperative lead. Therapy consists of single, 10 minute dose delivered proximal to site of decompression/repair

Timeline

• Start date: 2023-06-12
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2023-06-01
• Last updated: 2024-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study