Digital Nerve InjuryFASTR-TENNCT06867185
Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries
A study testing Brief Electrical Stimulation Therapy and Digital Nerve Repair in people with Digital Nerve Injury and Nerve Injury, run by Checkpoint Surgical Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Digital Nerve Injury, Nerve Injury, Nerve Reconstruction
- What is being tested?
- Brief Electrical Stimulation Therapy and Digital Nerve Repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 24 Apr 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University of Missouri Department of Orthopaedic Surgery
Columbia, Missouri, 65212
Research Coordinator, UMHSorthoenroll@health.missouri.edu
Daniel London, MD
- Recruiting
The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
Columbus, Ohio, 43212
Research Coordinator, (614)-293-8566, nervenerds@osumc.edu
Amy M Moore, MD
- Recruiting
Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260
Melanie Glover, mglover@orthoindy.com
Brandon S Smetana, MD, FAAOS
- Recruiting
Harborview Medical Center - University of Washington
Seattle, Washington, 98104
Research Coordinator, traumaresearch@uw.edu
Yusha Katie Liu, MD, PhD
- Recruiting
Washington University in St Louis, Department of Orthopedic Surgery
St Louis, Missouri, 63110
Clinical Reseach Coordinator, (314) 454-5967
Christopher Dy, MD, MPH
About this study
Official title: Function And Speed of Transection Recovery After Therapeutic Electrostimulation of Nerves
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
- Being tested
- Brief Electrical Stimulation Therapy, Digital Nerve Repair
- Keywords
- Nerve Repair, Therapeutic Electrical Stimulation, BES, Brief Electrical Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Electrical Stimulation TherapyDevice
Also called BES, Therapeutic Electrical Stimulation, Electrical Stimulation
10-minutes of electrical stimulation to repaired nerve
Digital Nerve RepairProcedure or surgery
Also called Nerve Repair
Standard of care surgical repair of digital nerve injury as determined by health care provider.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Repair | Active comparator | Individuals will receive standard of care surgical repair of their digital nerve injury as determined by their surgeon. Receives: Procedure: Digital Nerve Repair |
| Repair + Therapy | Experimental | During the surgical repair for digital nerve injury (standard of care), a 10 minute dose of therapeutic electrical stimulation will be delivered during surgery. Receives: Device: Brief Electrical Stimulation Therapy; Procedure: Digital Nerve Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks - 9 months
Secondary outcomes (4)
Semmes-Weinstein Monofilament Test
Evaluation of sensory function, measuring pressure detection threshold. Evaluated at each follow-up visit.
Measured: 2 weeks - 9 months
Visual Analog Scale (VAS)
Self reported rating of pain marked on a 100mm visual analog scale. Evaluated at each follow-up visit.
Measured: 2 weeks - 9 months
quick Disabilities of Arm, Hand, and Shoulder (quickDASH)
Questionnaire providing patient reported estimate upper extremity function following injuries or disorders to the arm, hand, or shoulder. Responses to 11 questions answered on a 1-5 scale are used to calculate a scorescore ranging from 0 (no disability) to 100 (most severe disability). Evaluated at each follow-up visit.
Measured: 2 weeks - 9 months
Michigan Hand Outcomes Questionnaire (MHQ)
A patient reported questionnaire consisting of 37 questions answered on a 1-5 scale used to calculate an estimate of hand function on a 0-100 scale with a higher number indication greater hand function. Evaluated at each follow-up visit.
Measured: 2 weeks - 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start24 Apr 2025
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Digital Nerve InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Checkpoint Surgical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867185
- Sponsor's protocol ID
- 0153-CSP-300
- Acronym
- FASTR-TEN
- Status last verified
- Jan 2026
- First submitted
- 25 Feb 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 35139047Sayanagi 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.
PubMed 34668879Saffari 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.
PubMed 38600968Wong 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.
PubMed 25727139
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Function And Speed of Transection Recovery After Therapeutic Electrostimulation of Nerves
- ClinicalTrials.gov ID
- NCT06867185
- Acronym / sponsor ID
- FASTR-TEN / 0153-CSP-300
- Conditions
- Digital Nerve Injury, Nerve Injury, Nerve Reconstruction, Nerve Trauma, Digital Nerve Lesion
- Keywords
- Nerve Repair, Therapeutic Electrical Stimulation, BES, Brief Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Checkpoint Surgical Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Repair | Active comparator | Procedure: Digital Nerve RepairIndividuals will receive standard of care surgical repair of their digital nerve injury as determined by their surgeon. |
| Repair + Therapy | Experimental | Device: Brief Electrical Stimulation Therapy, Procedure: Digital Nerve RepairDuring the surgical repair for digital nerve injury (standard of care), a 10 minute dose of therapeutic electrical stimulation will be delivered during surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Electrical Stimulation TherapyAlso: BES, Therapeutic Electrical Stimulation, Electrical Stimulation10-minutes of electrical stimulation to repaired nerve | Device | Repair + Therapy |
| Digital Nerve RepairAlso: Nerve RepairStandard of care surgical repair of digital nerve injury as determined by health care provider. | Procedure or surgery | Repair + Therapy, Standard of Care Repair |
Primary outcome
Two Point Discrimination
Time frame: 2 weeks - 9 months
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Background: PubMed 35139047Roh 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.
- Background: PubMed 34668879Sayanagi 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.
- Background: PubMed 38600968Saffari 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.
- Background: PubMed 25727139Wong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Electrical Stimulation Therapy and Digital Nerve Repair in people with Digital Nerve Injury and Nerve Injury, run by Checkpoint Surgical Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Director of Clincal Reseach (877-478-9106, clinical@checkpointsurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two Point Discrimination (time frame: 2 weeks - 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06867185, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.