Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries

Purpose

The goal of this clinical study is to evaluate if a period of electrical stimulation delivered during the surgical repair procedure can speed up nerve healing.

Conditions

  • Digital Nerve Injury
  • Nerve Injury
  • Nerve Reconstruction
  • Nerve Trauma
  • Digital Nerve Lesion

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 18-80 years - Candidate for surgical intervention under general anesthesia. - Require primary nerve injury repair in at least 1 digital nerve. - Following resection, have a resulting nerve gap of ≤ 10mm. - Able to complete tension-free end-to-end direct repair, or repair with a conduit, autograft, or allograft with a length ≤15mm - Signed and dated informed consent form.

Exclusion Criteria

  • Severe comorbid conditions, such as arrhythmia or congestive heart failure, preventing surgery under general anesthesia. - Nerve repair occurring >1 month post-injury. - Incomplete nerve transection. - Injury requiring replantation of target digit - Injury distal to the distal interphalangeal joint. - Injury proximal to branching into the proper or common digital nerves. - Injuries to both digital arteries of an affected digit. - History of neuropathy, diabetic neuropathy, or any other known neuropathy - History of chronic ischemic condition of the upper extremity - Cognitive impairment preventing the ability to provide consent, follow post-operative instructions, or complete clinical assessments.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard of Care Repair 		Individuals will receive standard of care surgical repair of their digital nerve injury as determined by their surgeon.
  • Procedure: Digital Nerve Repair
    Standard of care surgical repair of digital nerve injury as determined by health care provider.
    Other names:
    • Nerve Repair
Experimental
Repair + Therapy 		During the surgical repair for digital nerve injury (standard of care), a 10 minute dose of therapeutic electrical stimulation will be delivered during surgery.
  • Device: Brief Electrical Stimulation Therapy
    10-minutes of electrical stimulation to repaired nerve
    Other names:
    • BES
    • Therapeutic Electrical Stimulation
    • Electrical Stimulation
  • Procedure: Digital Nerve Repair
    Standard of care surgical repair of digital nerve injury as determined by health care provider.
    Other names:
    • Nerve Repair

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University in St Louis, Department of Orthopedic Surgery
St Louis 4407066, Missouri 4398678 63110
Contact:
Clinical Reseach Coordinator
(314) 454-5967

More Details

NCT ID
NCT06867185
Status
Recruiting
Sponsor
Checkpoint Surgical Inc.

Study Contact

Director of Clincal Reseach
877-478-9106
clinical@checkpointsurgical.com