The Utility of NIOM During LITT for Refractory MTLE

NCT02913742 | Withdrawn

• 1 other identifier: Pro00074452
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Mesial temporal lobe epilepsy (MTLE) is the most common cause of medication-resistant epilepsy in adults, and MRI-guided laser interstitial thermal therapy is a new approach to its surgical management; however, while LITT demonstrates fewer complications than traditional surgical techniques, it generates lower rates of seizure freedom. During traditional temporal lobectomy for MTLE, neurophysiologic intraoperative monitoring (NIOM) can be used to better identify epileptogenic tissue and guide resection. Our study proposes to investigate the utility of NIOM during LITT for MTLE. Subjects will be drawn from refractory mesial temporal lobe epilepsy patients determined to be candidates for LITT. During their LITT surgery, in addition to the placement of the stereotactic LITT probe, subjects will receive a second smaller stereotactic electrode for intraoperative monitoring of epileptic discharges before and after surgery. After surgery, at regularly scheduled follow-ups, patients will receive the Quality of Life in Epilepsy questionnaire (QOLIE-31-P), in addition to standard post-operative care. Endpoints will be surgical complications, fractional decrement in epileptiform discharges from pre- to post-ablation recordings, and surgical outcome at 6 months and one year. Analysis of severe complications will be expressed as a simple complication rate, for overall complications, severe complications, and hemorrhagic complications in specific. The relationship between fractional discharge decrement and outcome will be assessed by regression analysis. Risks of the study will stem from the placement of the stereotactic electrode for intraoperative monitoring, which represents a small incremental risk beyond typical LITT for MTLE.

Conditions

Epilepsy, Temporal Lobe

Keywords

Intraoperative Neurophysiological Monitoring

Outcome Measures

Primary Outcomes (2)

• fractional decrement in interictal epileptiform discharges (ID) from pre- to post-ablation

  Analysis of NIOM ID recordings will focus on fractional decrement of discharge counts from pre- to post-operative recordings. Fractional decrement was chosen, as opposed to absolute discharge counts, which are expected to vary widely among patients. Fractional discharge decrement will be assessed for its association with surgical outcome.

  30 day post-operative course

• Surgical complications associated with intraoperative monitoring electrodes and recording

  Analysis of safety will occur in an ongoing fashion, and at completion of the trial. Major complications will be reviewed immediately per institutional review board (IRB) approved protocols, and will trigger a project safety evaluation. Moderate and minor complications will be recorded, with results reviewed quarterly, to assess project safety. Final safety results will be compared to registry data of institutional MTLE LITT procedures and to published LITT results for MTLE.

  Perioperative through 30 days post-operation

Secondary Outcomes (1)

• Epilepsy surgery outcome

  Perioperative through 30 days post-operation

Study Arms (1)

monitoring by depth electrode

EXPERIMENTAL

Subjects will be drawn from refractory mesial temporal lobe epilepsy patients determined to be candidates for LITT. During their LITT surgery, in addition to the placement of the stereotactic LITT probe, subjects will receive a second smaller stereotactic electrode for intraoperative monitoring of epileptic discharges before and after surgery. After surgery, at regularly scheduled follow-ups, patients will receive a QOLIE-31-P questionnaire, in addition to standard post-operative care.

Procedure: monitoring by depth electrode

Interventions

monitoring by depth electrode PROCEDURE

During laser interstitial thermal ablation (LITT) for mesial temporal lobe epilepsy, the study patients will receive invasive neurophysiologic intraoperative monitoring. In addition to the typical placement of LITT stereotactic laser ablation probe via occipital burr hole, the study patients will receive an 8-contact depth recording electrode placed through an adjacent burr hole. The recording electrode will be placed into the parahippocampal gyrus in parallel to the LITT device. The patient will be monitored for epileptic discharges for 10 minutes before and 10 minutes after the ablation process to record the change in discharges during the surgery. The monitoring will not be used to guide surgery. The probe will be removed with the LITT device at the end of the procedure.

monitoring by depth electrode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• The patient must suffer from drug resistant mesial temporal lobe epilepsy as determined by a consensus of providers at weekly epilepsy surgery conferences held by the Duke Epilepsy Center
• The patient must be a candidate for LITT for MTLE as determined by a consensus of providers at weekly epilepsy surgery conferences held by the Duke Epilepsy Center

You may not qualify if:

• Age ≤ 18
• Lack of consensus on localization of MTLE
• Multifocal epilepsy
• History of prior epilepsy surgery
• Lack of consensus on candidacy for LITT
• Pregnancy
• Patient without capacity to provide legal consent

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Luedke MW, Pietak MR, Serafini S, Haglund MM, Sinha SR. Intraoperative ECoG During MRI-Guided Laser-Interstitial Thermal Therapy for Intractable Epilepsy. J Clin Neurophysiol. 2016 Aug;33(4):e28-30. doi: 10.1097/WNP.0000000000000299.

  PMID: 27261642 BACKGROUND

MeSH Terms

Conditions

Epilepsy, Temporal Lobe

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Study Officials

• Matthew W Luedke, MD

  Duke University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 26, 2016
• Study Start: March 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 28, 2017

Record last verified: 2016-08

Locations

US (1)