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study is going to be redesigned
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The purpose of this research study is to find out if using direct electrical stimulation during surgery is safe and helpful for people with nerve problems caused by compressed nerves.
The overall objective of this study is to establish the safety and utility of direct electrical stimulation as part of surgical intervention for compressive neuropathies of peripheral nerves and nerve roots. Stimulation will be provided with the Checkpoint Guardian which is a single-use, hand-held device cleared for the stimulation of exposed motor nerves or muscle tissue to locate and identify nerves. The central hypothesis is that electrical stimulation of the peripheral nerve or spinal nerve root at the time of decompressive surgery will improve motor strength and functional outcomes for patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerve Root Stimulation Arm | Experimental | patients undergoing spine surgery for decompression of the nerve root |
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| Peripheral Nerve Stimulation Arm | Experimental | patients undergoing peripheral nerve decompression in an upper extremity |
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| Nerve Root Control Arm | Active Comparator | patients undergoing spine surgery for decompression of the nerve root |
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| Peripheral Nerve Control Arm | Active Comparator | patients undergoing peripheral nerve decompression in an upper extremity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve Root Electrical Stimulation | Device | in addition to standard of care surgical decompression will receive 10 minutes of electrical stimulation at an amplitude of 2 mA with the Checkpoint nerve stimulator to the nerve root at the time of decompressive surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Medical Research Council Scale for Muscle Strength Score | The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength. | Baseline |
| Medical Research Council Scale for Muscle Strength Score | The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength. | Month 1 |
| Medical Research Council Scale for Muscle Strength Score | The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength. | Month 3 |
| Medical Research Council Scale for Muscle Strength Score | The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength. | Year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index Score | Participants in the nerve root stimulation arm will be given the The Oswestry Disability Index which is a self-administered questionnaire used to measure permanent functional disability caused by low back pain. It consists of 10 items covering pain and physical activities, with scores ranging from 0 (no disability) to 100 (maximum disability). | Baseline, Month 1, Month 3, Year 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Dibble, MD | Atrium Health Wake Forest Baptist | Principal Investigator |
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| ID | Term |
|---|---|
| C536965 | Tomaculous neuropathy |
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researcher measuring patient reported outcomes will be blinded to the treatment participants received
| Peripheral Nerve Electrical Stimulation | Device | in addition to standard of care surgical decompression will receive 10 minutes of electrical stimulation at an amplitude of 2 mA with the Checkpoint nerve stimulator to the peripheral nerve at the time of decompressive surgery |
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| Standard Treatment - Nerve Root | Other | standard surgical treatment when undergoing spine surgery for decompression of the nerve root |
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| Standard Treatment - Peripheral Nerve | Other | standard surgical treatment when undergoing peripheral nerve decompression in an upper extremity |
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| Patient Reported Outcomes Measurement Information System (PROMIS) Score | Score range from 20-80 with high scores indicating better function while lower scores indicate poorer function. | Baseline, Month 1, Month 3, Year 1 |
| Disabilities of the Arm Shoulder and Hand Score | Participants in the peripheral nerve stimulation arm will be given the Disabilities of the Arm Shoulder and Hand questionnaire which is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). | Baseline, Month 1, Month 3, Year 1 |
| Short Form Health Survey Score | Participants in the peripheral nerve stimulation arm will be given the SF-36. There are 36 items with score range from 0-100 with a higher score indicating a better functional state with few limitations/disabilities while a low score indicates a poorer functional state with more disability and limitations. | Baseline, Month 1, Month 3, Year 1 |