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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
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
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
standard surgical treatment when undergoing spine surgery for decompression of the nerve root
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Year 1
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).
Time frame: Baseline, Month 1, Month 3, Year 1
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.
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standard surgical treatment when undergoing peripheral nerve decompression in an upper extremity
Time frame: 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).
Time frame: 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.
Time frame: Baseline, Month 1, Month 3, Year 1