The Utility of NIOM During LITT for Refractory MTLE
| Status: | Withdrawn |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/29/2017 |
| Start Date: | March 2017 |
| End Date: | December 2019 |
A Prospective Study of the Utility of Neurophysiologic Intraoperative Monitoring by Stereotactic Depth Electrodes During MRI-guided Laser-interstitial Thermal Therapy for Refractory Mesial Temporal Lobe Epilepsy
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.
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.
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 decrements in discharge frequency from pre-ablation to
post-ablation recordings will be significantly associated with better seizure outcomes,
as measured by International League Against Epilepsy (ILAE) surgical outcome scores.
Objectives:
The primary project goals are to assess if NIOM by parahippocampal depth electrode is safe
during LITT of MTLE and to assess if the fractional decrement of interictal discharges (ID)
on NIOM can be significantly correlated with outcome. The study will be powered to address
these questions a priori. Post hoc analyses consisting of a multivariate analysis of other
patient demographic data, NIOM findings, operative parameters, quality of life scores, and
neuropsychiatric outcomes will also be assessed.
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 decrements in discharge frequency from pre-ablation to
post-ablation recordings will be significantly associated with better seizure outcomes,
as measured by International League Against Epilepsy (ILAE) surgical outcome scores.
Objectives:
The primary project goals are to assess if NIOM by parahippocampal depth electrode is safe
during LITT of MTLE and to assess if the fractional decrement of interictal discharges (ID)
on NIOM can be significantly correlated with outcome. The study will be powered to address
these questions a priori. Post hoc analyses consisting of a multivariate analysis of other
patient demographic data, NIOM findings, operative parameters, quality of life scores, and
neuropsychiatric outcomes will also be assessed.
Inclusion criteria are as follows
1. Age ≥ 18
2. 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
3. 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
Exclusion criteria are as follows
1. Age ≤ 18
2. Lack of consensus on localization of MTLE
3. Multifocal epilepsy
4. History of prior epilepsy surgery
5. Lack of consensus on candidacy for LITT
6. Pregnancy
7. Patient without capacity to provide legal consent
We found this trial at
1
site
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
