Compression Neuropathy
Conditions
Keywords
decompressive surgery, peripheral nerves, electrical stimulation
Brief summary
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.
Detailed description
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.
Interventions
DEVICENerve Root Electrical Stimulation
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
DEVICEPeripheral Nerve Electrical Stimulation
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
OTHERStandard Treatment - Nerve Root
standard surgical treatment when undergoing spine surgery for decompression of the nerve root
OTHERStandard Treatment - Peripheral Nerve
standard surgical treatment when undergoing peripheral nerve decompression in an upper extremity
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
researcher measuring patient reported outcomes will be blinded to the treatment participants received
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Nerve root stimulation arm: Clinical and radiographic findings of compressive neuropathy at the level of the nerve root, including myelopathy and/ or radiculopathy, who are planning for minimally invasive or open spine surgery to decompress the nerve. * Peripheral nerve stimulation arm: Compressive peripheral neuropathy, including cubital tunnel, carpal tunnel and peroneal nerve compression who are planning to undergo surgical decompression in the affected upper extremity.
Exclusion criteria
* Patients that had previous nerve transfers for cervical spinal cord injury or tendon transfers, as they would not benefit from this procedure. * Any implanted electronic devices, including pacemakers * Pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical Research Council Scale for Muscle Strength Score | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index Score | Baseline, Month 1, Month 3, Year 1 | 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). |
| Patient Reported Outcomes Measurement Information System (PROMIS) Score | Baseline, Month 1, Month 3, Year 1 | Score range from 20-80 with high scores indicating better function while lower scores indicate poorer function. |
| Disabilities of the Arm Shoulder and Hand Score | Baseline, Month 1, Month 3, Year 1 | 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). |
| Short Form Health Survey Score | Baseline, Month 1, Month 3, Year 1 | 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. |
Contacts
PRINCIPAL_INVESTIGATORChristopher Dibble, MD
Atrium Health Wake Forest Baptist
Outcome results
None listed