Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries
FASTR-TEN
Function And Speed of Transection Recovery After Therapeutic Electrostimulation of Nerves
1 other identifier
interventional
60
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2025
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2025
CompletedFirst Posted
Study publicly available on registry
March 10, 2025
CompletedStudy Start
First participant enrolled
April 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
January 9, 2026
January 1, 2026
1.7 years
February 25, 2025
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Two Point Discrimination
Evaluation of sensory function based on ability to discern two point of contact for different distances between the contacts (2-15mm). Evaluated at each follow-up visit.
2 weeks - 9 months
Secondary Outcomes (4)
Semmes-Weinstein Monofilament Test
2 weeks - 9 months
Visual Analog Scale (VAS)
2 weeks - 9 months
quick Disabilities of Arm, Hand, and Shoulder (quickDASH)
2 weeks - 9 months
Michigan Hand Outcomes Questionnaire (MHQ)
2 weeks - 9 months
Study Arms (2)
Standard of Care Repair
ACTIVE COMPARATORIndividuals will receive standard of care surgical repair of their digital nerve injury as determined by their surgeon.
Repair + Therapy
EXPERIMENTALDuring the surgical repair for digital nerve injury (standard of care), a 10 minute dose of therapeutic electrical stimulation will be delivered during surgery.
Interventions
10-minutes of electrical stimulation to repaired nerve
Standard of care surgical repair of digital nerve injury as determined by health care provider.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260, United States
University of Missouri Department of Orthopaedic Surgery
Columbia, Missouri, 65212, United States
Washington University in St Louis, Department of Orthopedic Surgery
St Louis, Missouri, 63110, United States
The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
Columbus, Ohio, 43212, United States
Harborview Medical Center - University of Washington
Seattle, Washington, 98104, United States
Related Publications (4)
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: 35139047BACKGROUNDSayanagi 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: 34668879BACKGROUNDSaffari 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: 38600968BACKGROUNDWong 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: 25727139BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2025
First Posted
March 10, 2025
Study Start
April 24, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
January 9, 2026
Record last verified: 2026-01