Evoked Potential Response to Full-endoscopic Cervical Foraminotomy

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

Study Overview

• Status: Completed
• Conditions: Cervical Foraminal Stenosis
• Intervention / Treatment: Procedure: Medtronic NIM Eclipse for evoked potentials recording

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • CHR Citadelle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional de la Citadelle

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 22, 2022
• Primary Completion (ACTUAL): February 23, 2022
• Study Completion (ACTUAL): February 24, 2022

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: April 9, 2022
• First Posted (ACTUAL): April 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Endoscopy; Evoked Potential; Irrigation pressure; Dorsal columns
• Other Study ID Numbers: Evoked cervical endoscopy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No