CompletedNot Applicable

Evoked Potential Response to Full-endoscopic Cervical Foraminotomy

Belgium3 participantsStarted 2022-02-22

Plain-language 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

Who can participate

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Influence of the endoscopic irrigation pressure on somatosensory evoked potentials.

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

Influence of the endoscopic irrigation pressure on motor evoked potentials.

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

Trial details

NCT IDNCT05326698

SponsorCentre Hospitalier Régional de la Citadelle

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-02-23

View on ClinicalTrials.gov More Cervical Foraminal Stenosis trials

Plain-language summary

Who can participate

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Influence of the endoscopic irrigation pressure on somatosensory evoked potentials.

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

Influence of the endoscopic irrigation pressure on motor evoked potentials.

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