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Evoked Potential Response to Full-endoscopic Cervical Foraminotomy

Evoked Potential Response to Full-endoscopic Cervical Foraminotomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05326698
Enrollment
3
Registered
2022-04-13
Start date
2022-02-22
Completion date
2022-02-24
Last updated
2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Foraminal Stenosis

Keywords

Evoked Potential, Endoscopy, Irrigation pressure, Dorsal columns

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

Interventions

PROCEDUREMedtronic NIM Eclipse for evoked potentials recording

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

Sponsors

Centre Hospitalier Régional de la Citadelle
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

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

Design outcomes

Primary

MeasureTime frameDescription
Influence of the endoscopic irrigation pressure on somatosensory evoked potentials.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.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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026