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

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Key information

Conditions

Cervical Foraminal Stenosis

Study type

Observational

Primary location

CHR Citadelle

Liège, 4000, Belgium

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Medtronic NIM Eclipse for evoked potentials recording

Procedure

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

Other names: Joimax Ilessys Pro for endoscopic cervical foraminotomy

Primary outcomes

Influence of the endoscopic irrigation pressure on somatosensory evoked potentials.

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

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

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

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional de la Citadelle

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Apr 13, 2022
Registry last updated: Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.