Evoked Potential Response to Full-endoscopic Cervical Foraminotomy

Cervical Foraminal Stenosis Clinical Trial

Official title:

Evoked Potential Response to Full-endoscopic Cervical Foraminotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05326698
• Other study ID #: Evoked cervical endoscopy
• Status: Completed
• Start date: February 22, 2022
• Est. completion date: February 24, 2022

Study information

• Verified date: April 2022
• Source: Centre Hospitalier Régional de la Citadelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 24, 2022
• Est. primary completion date: February 23, 2022
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Cervical Foraminal Stenosis

Intervention

Procedure:
• Medtronic NIM Eclipse for evoked potentials recording
Recording of somesthetic and motor evoked potentials during endoscopic posterior cervical foraminotomy.

Locations

Country	Name	City	State
Belgium	CHR Citadelle	Liège

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional de la Citadelle

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.