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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH1920065 | Other Grant/Funding Number | Department of Defense USAMRAA |
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| Name | Class |
|---|---|
| Congressionally Directed Medical Research Programs | FED |
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This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for peripheral nerve injury in arm. Participants will be randomized into one of two groups, treatment or control, with all participants receiving standard of care treatment for the nerve injury. The treatment group will also receive a single dose of the therapeutic stimulation during the surgical intervention for their nerve injury.
Preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery. This pilot study is investigating the use of a single dose of therapeutic electrical stimulation to promote nerve healing. The therapy is delivered as part of the surgical intervention to address peripheral nerve injury in the arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Electrical Stimulation Therapy | Experimental | Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention. |
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| Standard of Care | No Intervention | Surgical intervention for repair of peripheral nerve injury. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Checkpoint BEST System | Device | Single use medical device, consisting of electric stimulator and intraoperative lead. Therapy consists of single, 10 minute dose delivered proximal to site of decompression/repair |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading | Grading of muscle strength on 0 to 5 scale, with higher score representing greater function. | Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Grip Strength | Maximum grip strength. | Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months |
| Lateral Pinch Strength | Maximum lateral pinch. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Walker, PhD | Contact | 216-370-9107 | 101 | ewalker@checkpointsurgical.com |
| Name | Affiliation | Role |
|---|---|---|
| Amy M Moore, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery | Recruiting | Columbus | Ohio | 43212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31397919 | Background | Jo S, Pan D, Halevi AE, Roh J, Schellhardt L, Hunter Ra DA, Snyder-Warwick AK, Moore AM, Mackinnon SE, Wood MD. Comparing electrical stimulation and tacrolimus (FK506) to enhance treating nerve injuries. Muscle Nerve. 2019 Nov;60(5):629-636. doi: 10.1002/mus.26659. Epub 2019 Aug 21. | |
| 34668879 | Background | 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. |
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| ID | Term |
|---|---|
| D059348 | Peripheral Nerve Injuries |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months |
| 2-point discrimination | Evaluation of sensory function, measuring tactile discrimination. | Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months |
| Semmes-Weinstein Monofilament Testing | Evaluation of sensory function, measuring pressure detection threshold. | Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months |
| Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function | Questionnaire providing patient reported estimate of upper extremity function on a 0-100 scale with >50 representing greater normal function. | Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months |
| Patient Reported Outcome Measurement System (PROMIS) Pain Interference | Questionnaire providing patient reported estimate of interference of pain on daily activities on a 0-100 scale with >50 representing greater than normal pain interference on daily activities. | Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months |
| quick Disabilities of thee Arm, Shoulder, and Hand (DASH) questionnaire | Questionnaire providing patient reported estimate upper extremity function. The score ranges from 0 (no disability) to 100 (most severe disability). | Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months |
| Electromyography (EMG) | Measurement of the electrical activity in a muscle. | 4 months, 6 months, and 8 months |
| Motor Unit Number Estimation (MUNE) | Estimate of the number of motor units within the muscle based on recorded electrical activity. | 4 months, 6 months, and 8 months |
| 35139047 | Background | 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. |
| 25727139 | Background | 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. |
| 36551285 | Background | Juckett L, Saffari TM, Ormseth B, Senger JL, Moore AM. The Effect of Electrical Stimulation on Nerve Regeneration Following Peripheral Nerve Injury. Biomolecules. 2022 Dec 12;12(12):1856. doi: 10.3390/biom12121856. |
| 32666827 | Background | Keane GC, Pan D, Roh J, Larson EL, Schellhardt L, Hunter DA, Snyder-Warwick AK, Moore AM, Mackinnon SE, Wood MD. The Effects of Intraoperative Electrical Stimulation on Regeneration and Recovery After Nerve Isograft Repair in a Rat Model. Hand (N Y). 2022 May;17(3):540-548. doi: 10.1177/1558944720939200. Epub 2020 Jul 15. |
| D014947 | Wounds and Injuries |