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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Checkpoint Surgical Inc.
Study ID
NCT06867185
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Brief Electrical Stimulation Therapy — DEVICE
    10-minutes of electrical stimulation to repaired nerve
  • Digital Nerve Repair — PROCEDURE
    Standard of care surgical repair of digital nerve injury as determined by health care provider.

Study Details

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.

Key Dates

Start date
Apr 24, 2025
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care Repair
    Individuals will receive standard of care surgical repair of their digital nerve injury as determined by their surgeon.
  • 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.

Primary Outcome Measure

Two Point Discrimination [ Time Frame: 2 weeks - 9 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Indiana Hand to Shoulder CenterIndianapolisIndiana46260
Melanie Glover
[email protected]
Brandon S Smetana, MD, FAAOS (PRINCIPAL_INVESTIGATOR)
Ian Chow, MD (SUB_INVESTIGATOR)
Nicholas E Crosby, MD (SUB_INVESTIGATOR)
Jeffrey A Greenberg, MD, MS (SUB_INVESTIGATOR)
F. Thomas D Kaplan, MD, FAAOS (SUB_INVESTIGATOR)
Gregory A Merrell, MD (SUB_INVESTIGATOR)
Kathryn M Peck, MD (SUB_INVESTIGATOR)
Sameer K Puri, MD (SUB_INVESTIGATOR)
University of Missouri Department of Orthopaedic SurgeryColumbiaMissouri65212
Research Coordinator
[email protected]
Daniel London, MD (PRINCIPAL_INVESTIGATOR)
Julia Nuelle, MD (SUB_INVESTIGATOR)
Sebastien Lalonde, MD (SUB_INVESTIGATOR)
Washington University in St Louis, Department of Orthopedic SurgerySt LouisMissouri63110
Clinical Reseach Coordinator
(314) 454-5967
Christopher Dy, MD, MPH (PRINCIPAL_INVESTIGATOR)
David Brogan, MD, MSc (SUB_INVESTIGATOR)
The Ohio State Univeristy - Department of Plastic and Reconstructive SurgeryColumbusOhio43212
Research Coordinator
[email protected]
(614)-293-8566
Amy M Moore, MD (PRINCIPAL_INVESTIGATOR)
Andrew O'Brien, MD (SUB_INVESTIGATOR)
Jill Putnam, MD (SUB_INVESTIGATOR)
Ryan Schmucker, MD (SUB_INVESTIGATOR)
Harborview Medical Center - University of WashingtonSeattleWashington98104
Research Coordinator
[email protected]
Yusha Katie Liu, MD, PhD (PRINCIPAL_INVESTIGATOR)
Chelsea Boe, MD (SUB_INVESTIGATOR)
Christopher Crowe, MD (SUB_INVESTIGATOR)
Jeffrey Friedrich, MD, MC, FACS (SUB_INVESTIGATOR)
Stephen Kennedy, MD, FRCSC (SUB_INVESTIGATOR)
Erin Miller, MD, MS (SUB_INVESTIGATOR)

Find similar trials in Indianapolis, IN

By research site
Indiana Hand to Shoulder Center· Indianapolis, INUniversity of Missouri Department of Orthopaedic Surgery· Columbia, MOWashington University in St Louis, Department of Orthopedic Surgery· St Louis, MOThe Ohio State Univeristy - Department of Plastic and Reconstructive Surgery· Columbus, OHHarborview Medical Center - University of Washington· Seattle, WA

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