Clinical Trial: The Utility of NIOM During LITT for Refractory MTLE

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Prospective Study of the Utility of Neurophysiologic Intraoperative Monitoring by Stereotactic Depth Electrodes During MRI-guided Laser-interstitial Thermal Therapy for Refractory Mesial

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.

Detailed Summary:

Mesial temporal lobe epilepsy (MTLE) is the most common cause of medication-resistant epilepsy in adults. The standard treatment for refractory MTLE is surgical resection by craniotomy. Stereotactic laser interstitial thermal therapy (LITT) is a new surgical technique being used to treat MTLE. Under MRI-guidance, a laser probe is inserted into the seizure focus and heat is used to destroy the tissue. Compared to temporal lobectomy, LITT results in shorter hospital stays, low complication rates, and possibly less cognitive decline; however, seizure freedom rates are potentially lower.

During temporal lobectomy, neurophysiologic intraoperative monitoring (NIOM) can be used to better identify epileptogenic tissue and guide resection. This tool has been unavailable during LITT procedures. Recently, the investigators demonstrated in two cases that NIOM with a depth electrode is technically feasible during LITT and can identify epileptiform activity intra-operatively.

This is a prospective trial of NIOM during LITT for mesial temporal lobe epilepsy. The investigators will assess the safety of performing NIOM during LITT and whether data from NIOM (frequency and characteristics of epileptiform discharges recorded before and after ablation) are associated with seizure outcomes. If there is an association, NIOM could be used for prognostication and could potentially even be used to guide surgery.

Hypotheses:

  1. NIOM performed by MRI-guided stereotactic depth electrode placed in the parahippocampal gyrus adjacent to the LITT catheter is safe, as compared to institutional LITT controls without NIOM and published LITT complication rates.
  2. Greater magnitude fractional decreme
    Sponsor: Duke University

    Current Primary Outcome:

    • fractional decrement in interictal epileptiform discharges (ID) from pre- to post-ablation [ Time Frame: 30 day post-operative course ]
      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.
    • Surgical complications associated with intraoperative monitoring electrodes and recording [ Time Frame: Perioperative through 30 days post-operation ]
      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.


    Original Primary Outcome:

    • fractional decrement in interictal epileptiform discharges (ID) from pre- to post-ablation [ Time Frame: 30 day post-operative course ]
      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.
    • Surgical complications associated with intraoperative monitoring electrodes and recording [ Time Frame: Perioperative through 30 days post-operation ]
      Analysis of safety will occur in an ongoing fashion, and at completion of the trial. Major complications will be reviewed immediately per institutional 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.
    • epilepsy surgery outcome [ Time Frame: 6 months ]
      Outcome will be measured by the ILAE surgical outcome 6-point scale. Fractional ID decrement will be analyzed for their association with surgical outcomes.


    Current Secondary Outcome: Epilepsy surgery outcome [ Time Frame: Perioperative through 30 days post-operation ]

    Outcome will be measured by the ILAE surgical outcome 6-point scale. Fractional ID decrement will be analyzed for their association with surgical outcomes.


    Original Secondary Outcome:

    Information By: Duke University

    Dates:
    Date Received: September 22, 2016
    Date Started: March 2017
    Date Completion: December 2019
    Last Updated: April 27, 2017
    Last Verified: August 2016