Intraoperative Peripheral Nerve Stimulation

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Compression Neuropathy

Treatments: Device: Peripheral Nerve Electrical Stimulation; Other: Standard Treatment - Peripheral Nerve; Other: Standard Treatment - Nerve Root; Device: Nerve Root Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07592065

IRB00149854

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 4 patient groups

Nerve Root Stimulation Arm

Experimental group

Description:

patients undergoing spine surgery for decompression of the nerve root

Treatment:

Device: Nerve Root Electrical Stimulation

Peripheral Nerve Stimulation Arm

Experimental group

Description:

patients undergoing peripheral nerve decompression in an upper extremity

Treatment:

Device: Peripheral Nerve Electrical Stimulation

Nerve Root Control Arm

Active Comparator group

Description:

patients undergoing spine surgery for decompression of the nerve root

Treatment:

Other: Standard Treatment - Nerve Root

Peripheral Nerve Control Arm

Active Comparator group

Description:

patients undergoing peripheral nerve decompression in an upper extremity

Treatment:

Other: Standard Treatment - Peripheral Nerve