Evoked Potential Response to Full-endoscopic Cervical Foraminotomy

NCT05326698 | Completed

• 1 other identifier: Evoked cervical endoscopy
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical foraminotomy is used to treat recalcitrant foraminal stenosis in the cervical region. This foraminotomy can be performed under endoscopy. The irrigation pressure used to allow adequate visualization of the anatomical structures is usually between 40 and 50 mmHg. This pressure has no adverse effect intraoperatively on motor evoked potentials but its effect on somesthetic evoked potentials has not yet been studied. The purpose of this study is to validate the absence of disruption of somatosensory evoked potentials by endoscopic cervical foraminotomy

Conditions

Cervical Foraminal Stenosis

Keywords

Evoked Potential; Endoscopy; Irrigation pressure; Dorsal columns

Outcome Measures

Primary Outcomes (2)

• Influence of the endoscopic irrigation pressure on somatosensory evoked potentials.

  The evoked potentials electrodes were placed once the patient was asleep under general anesthesia, installed in a prone position in a Mayfield head holder. The electrodes were removed at the end of surgery after skin closure but before removing the headrest and returning the patient to his back. Somatosensory evoked potentials (SEP) were recorded continuously from electrode placement to electrode removal. The blood pressure and the irrigation pressure in the endoscope are also continuously recorded. A change SEP in latency and/or amplitude could therefore be detected during the entire recording and related to variations in irrigation pressure and intraoperative events.

  Through surgery completion, from electrodes placement until their removal. An average of two hours.

• Influence of the endoscopic irrigation pressure on motor evoked potentials.

  The evoked potentials electrodes were placed once the patient was asleep under general anesthesia, installed in a prone position in a Mayfield head holder. The electrodes were removed at the end of surgery after skin closure but before removing the headrest and returning the patient to his back. Motor evoked potentials (MEP) were recorded at each step of the surgery (preoperative, skin incision, working tube placement, endoscope introduction, and foraminotomy) and also at each variation of the irrigation pressure. A change MEP amplitude could therefore be detected during the entire recording and related to variations in irrigation pressure and intraoperative events.

  Through surgery completion, from electrodes placement until their removal. An average of two hours.

Interventions

Medtronic NIM Eclipse for evoked potentials recording PROCEDURE

Recording of somesthetic and motor evoked potentials during endoscopic posterior cervical foraminotomy.

Also known as: Joimax Ilessys Pro for endoscopic cervical foraminotomy

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

3 patients will undergo endoscopic surgery on February 22 and 23, 2022 for a cervical foraminotomy to treat foraminal stenosis responsible for recalcitrant cervicobrachial pain. These surgeries will be performed with pre-, per- and post-operative recording of motor and sensory evoked potentials.

You may qualify if:

• Cervical radiculopathy due to foraminal stenosis
• Age \> 18 years
• Radicular arm pain that were refractory to optimal medical therapy for a minimum of 3 months.
• Persistent pain despite 3 types of pharmacological treatments (paracetamol, non-steroidal anti-inflammatory drugs, opioids, antidepressant medications, and anticonvulsant medications, etc.).
• Intact Llemniscal pathways must remain at least partially intact

You may not qualify if:

• History of coagulation disorders; Lupus erythematosus; diabetic neuropathy; rheumatoid arthritis; Morbus Bechterew; Active malignancy; immune deficiency
• Presence of myelopathy
• Addiction to drugs, alcohol (5 units/day) and/or medications

Sponsors & Collaborators

• Centre Hospitalier Régional de la Citadelle: lead

Study Sites (1)

CHR Citadelle

Liège, 4000, Belgium

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Neurosurgeon, Principal Investigator

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: April 13, 2022
• Study Start: February 22, 2022
• Primary Completion: February 23, 2022
• Study Completion: February 24, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

BE (1)