Recruiting NCT06867185
Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brief Electrical Stimulation Therapy, Digital Nerve Repair.
- Who it may be relevant to
- Registry conditions: Digital Nerve Injury, Nerve Injury, Nerve Reconstruction, Nerve Trauma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Function And Speed of Transection Recovery After Therapeutic Electrostimulation of Nerves
Overview
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.
Interventions
- Device Brief Electrical Stimulation Therapy
10-minutes of electrical stimulation to repaired nerve - Procedure Digital Nerve Repair
Standard of care surgical repair of digital nerve injury as determined by health care provider.
Primary outcome measures
- Two Point Discrimination [Time frame: 2 weeks - 9 months]
Secondary outcome measures (4)
- Semmes-Weinstein Monofilament Test [Time frame: 2 weeks - 9 months]
- Visual Analog Scale (VAS) [Time frame: 2 weeks - 9 months]
- quick Disabilities of Arm, Hand, and Shoulder (quickDASH) [Time frame: 2 weeks - 9 months]
- Michigan Hand Outcomes Questionnaire (MHQ) [Time frame: 2 weeks - 9 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Indiana Hand to Shoulder Center — Indianapolis
- University of Missouri Department of Orthopaedic Surgery — Columbia
- Washington University in St Louis, Department of Orthopedic Surgery — St Louis
- The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery — Columbus
- Harborview Medical Center - University of Washington — Seattle
Publications
- Roh J, Schellhardt L, Keane GC, Hunter DA, Moore AM, Snyder-Warwick AK, Mackinnon SE, Wood MD. Short-Duration, Pulsatile, Electrical Stimulation Therapy Accelerates Axon Regeneration and Recovery following Tibial Nerve Injury and Repair in Rats. Plast Reconstr Surg. 2022 Apr 1;149(4):681e-690e. doi: 10.1097/PRS.0000000000008924. PMID 35139047
- Sayanagi J, Acevedo-Cintron JA, Pan D, Schellhardt L, Hunter DA, Snyder-Warwick AK, Mackinnon SE, Wood MD. Brief Electrical Stimulation Accelerates Axon Regeneration and Promotes Recovery Following Nerve Transection and Repair in Mice. J Bone Joint Surg Am. 2021 Oct 20;103(20):e80. doi: 10.2106/JBJS.20.01965. PMID 34668879
- Saffari TM, Walker ER, Pet MA, Moore AM. Brief Intraoperative Electrical Stimulation to Enhance Nerve Regeneration. Plast Reconstr Surg Glob Open. 2024 Apr 10;12(4):e5730. doi: 10.1097/GOX.0000000000005730. eCollection 2024 Apr. No abstract available. PMID 38600968
- Wong JN, Olson JL, Morhart MJ, Chan KM. Electrical stimulation enhances sensory recovery: a randomized controlled trial. Ann Neurol. 2015 Jun;77(6):996-1006. doi: 10.1002/ana.24397. Epub 2015 May 4. PMID 25727139
Identifiers
NCT: NCT06867185 · 0153-CSP-300