Minimally Invasive Surgical Epilepsy Trial for Temporal Lobe Epilepsy

Minimally Invasive Surgery Clinical Trial

— MISET-TLE  

Official title:

Functional Anterior Temporal Lobectomy Via Minicraniotomy as a Novel Surgical Therapy for Temporal Lobe Epilepsy: a Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05019404
• Other study ID #: XJTU1AF2021LSK-194
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: November 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yong Liu, MD
• Phone: +8618049529896
• Email: liu868yong[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Temporal lobe epilepsy (TLE) is a chronically neurological disease characterized by progressive seizures. TLE is the most frequent subtype of refractory focal epilepsy in adults. Epilepsy surgery has proven to be very efficient in TLE and superior to medical therapy in two randomized controlled trials. According to the previous experience, the investigators use functional anterior temporal lobectomy (FATL) via minicraniotomy for TLE. To date, this minimally invasive open surgery has been not reported. The investigators here present a protocol of a prospective trail which for the first time evaluates the outcomes of this new surgical therapy for TLE.

Description:

Temporal lobe epilepsy (TLE) is a chronically neurological disease characterized by progressive seizures, followed by a latency period of several years after various injuries including febrile seizures, infection, trauma, tumors, and vascular malformation. Hippocampal sclerosis is the most common histopathological finding. The macroscopic changes of TLE with hippocampal sclerosis include the diminished size, sclerosis, and reduced metabolism in mesial temporal structures (amygdala, hippocampus, and parahippocampal gyrus). The microscopic changes include neuronal loss, gliosis, and axonal reorganization. As TLE progresses, most of patients become resistant to current antiepileptic drugs. Therefore, TLE is the most frequent subtype of refractory focal epilepsy in adults. Epilepsy surgery has proven to be very efficient for TLE and superior to medical therapy in two randomized controlled trials. Patients with surgical therapy have high seizure-free rate with the range of 60% to 80 % while less than 5% with medical treatment. Anterior temporal lobectomy (ATL) is the most frequently used approach for TLE. For patients with TLE, Engel suggested referral to ATL should be strongly considered. The decision analysis showed that ATL increased life expectancy and quality- adjusted life expectancy in patients with TLE compared with medical management. Nevertheless, ATL is performed by large frontotemporal craniotomy. Although complication rates after temporal lobectomy have decreased dramatically over time, ATL creates a large cavity with temporal lobe resected, causing potential complications such as bleeding, brain shifts and subdural collections. With the advances in minimally invasive surgery, surgical techniques of ATL for TLE need to be continuously improved. For this reason, the investigators modify the surgical approach. Functional anterior temporal lobectomy (FATL) via minicraniotomy is established. Recently, 25 patients with TLE undergoing FATL obtained satisfactory outcomes in our center (unpublished data). To date, this new open surgery for TLE has been not reported. The safety and efficacy of FATL need to be verified. Therefore, the investigators here present a protocol of the minimally invasive surgical epilepsy trial for TLE (MISET-TLE) which for the first time evaluates the outcomes of FATL as a new surgical approach for TLE.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. male or female aged between 18 and 60 years;

2. drug- resistant temporal lobe epilepsy, remaining seizures after two or more tolerated and appropriately chosen antiepileptic drugs;

3. monthly or more seizures during the preceding year prior to trial;

4. the full- scale intelligence quotient (IQ) more than 70, understanding and completing the trial;

5. signing the informed consent;

6. good compliance, at least 12- month follow- up after surgery.

Exclusion Criteria:

1. tumor in temporal lobe;

2. extratemporal epilepsy and temporal plus epilepsy;

3. drug- responsive epilepsy, seizure freedom with current drugs in recent one year;

4. pseudoseizures;

5. seizures arising from bilateral temporal lobes;

6. significant comorbidities including progressive neurological disorders, active psychosis, and drug abuse;

7. a full- scale IQ lower than 70, unable to complete tests;

8. previous epilepsy surgery;

9. poor compliance and inadequate follow- up.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe
• Minimally Invasive Surgery
• Open Surgery
• Temporal Lobe Epilepsy

Intervention

Procedure:
• Functional anterior temporal lobectomy (FATL)
Patients are placed in the supine position with the head contralaterally rotated 30°. The 3D model of incision and bone flap is printed prior to surgery by the slicer software based on the MRI data. Slightly curve incision with the length of about 6 cm in the temporal region is marked according to the 3D model. Temporal craniotomy via small bone window with the diameter of about 3 cm is performed. From the temporal pole along T1 about 5 cm posteriorly, temporal horn is opened by dissecting the middle temporal gyrus. The head of temporal horn is exposed. The amygdala is resected. Then, the parahippocampal gyrus and hippocampus are en bloc resected. The lateral temporal lobotomy is easy due to large view following the removal of mesial structures. The lateral posterior temporal lobotomy is no more than 5 cm from the temporal pole.
• Anterior temporal lobectomy (ATL)
Patients are placed in the supine position with the head contralaterally rotated 30°. Large frontotemporal craniotomy is performed. Question mark-shaped incision with the length of 20- 25 cm in the frontotemporal region is marked. The size of the bone flap is approximately 5×7 cm for the exposure of lateral temporal lobe. ATL consists of en bloc resection of the anterior 5 cm of lateral temporal lobe, followed by the removal of mesial structures including the amygdala, parahippocampal gyrus, and hippocampus.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (16)

Bjellvi J, Flink R, Rydenhag B, Malmgren K. Complications of epilepsy surgery in Sweden 1996-2010: a prospective, population-based study. J Neurosurg. 2015 Mar;122(3):519-25. doi: 10.3171/2014.9.JNS132679. Epub 2014 Oct 31. — View Citation

Brissart H, Planton M, Bilger M, Bulteau C, Forthoffer N, Guinet V, Hennion S, Kleitz C, Laguitton V, Mirabel H, Mosca C, Pecheux N, Pradier S, Samson S, Tramoni E, Voltzenlogel V, Denos M, Boutin M. French neuropsychological procedure consensus in epilepsy surgery. Epilepsy Behav. 2019 Nov;100(Pt A):106522. doi: 10.1016/j.yebeh.2019.106522. Epub 2019 Oct 15. — View Citation

Brotis AG, Giannis T, Kapsalaki E, Dardiotis E, Fountas KN. Complications after Anterior Temporal Lobectomy for Medically Intractable Epilepsy: A Systematic Review and Meta-Analysis. Stereotact Funct Neurosurg. 2019;97(2):69-82. doi: 10.1159/000500136. Epub 2019 Jul 9. — View Citation

Chang EF, Englot DJ, Vadera S. Minimally invasive surgical approaches for temporal lobe epilepsy. Epilepsy Behav. 2015 Jun;47:24-33. doi: 10.1016/j.yebeh.2015.04.033. Epub 2015 May 24. — View Citation

Choi H, Sell RL, Lenert L, Muennig P, Goodman RR, Gilliam FG, Wong JB. Epilepsy surgery for pharmacoresistant temporal lobe epilepsy: a decision analysis. JAMA. 2008 Dec 3;300(21):2497-505. doi: 10.1001/jama.2008.771. — View Citation

Engel J Jr, McDermott MP, Wiebe S, Langfitt JT, Stern JM, Dewar S, Sperling MR, Gardiner I, Erba G, Fried I, Jacobs M, Vinters HV, Mintzer S, Kieburtz K; Early Randomized Surgical Epilepsy Trial (ERSET) Study Group. Early surgical therapy for drug-resistant temporal lobe epilepsy: a randomized trial. JAMA. 2012 Mar 7;307(9):922-30. doi: 10.1001/jama.2012.220. — View Citation

Engel J Jr, Wiebe S, French J, Sperling M, Williamson P, Spencer D, Gumnit R, Zahn C, Westbrook E, Enos B. Practice parameter: temporal lobe and localized neocortical resections for epilepsy. Epilepsia. 2003 Jun;44(6):741-51. doi: 10.1046/j.1528-1157.2003.48202.x. — View Citation

Falowski SM, Wallace D, Kanner A, Smith M, Rossi M, Balabanov A, Ouyang B, Byrne RW. Tailored temporal lobectomy for medically intractable epilepsy: evaluation of pathology and predictors of outcome. Neurosurgery. 2012 Sep;71(3):703-9; discussion 709. doi: 10.1227/NEU.0b013e318262161d. — View Citation

Jones AL, Cascino GD. Evidence on Use of Neuroimaging for Surgical Treatment of Temporal Lobe Epilepsy: A Systematic Review. JAMA Neurol. 2016 Apr;73(4):464-70. doi: 10.1001/jamaneurol.2015.4996. — View Citation

O'Dell CM, Das A, Wallace G 4th, Ray SK, Banik NL. Understanding the basic mechanisms underlying seizures in mesial temporal lobe epilepsy and possible therapeutic targets: a review. J Neurosci Res. 2012 May;90(5):913-24. doi: 10.1002/jnr.22829. Epub 2012 Feb 8. — View Citation

Schmeiser B, Wagner K, Schulze-Bonhage A, Mader I, Wendling AS, Steinhoff BJ, Prinz M, Scheiwe C, Weyerbrock A, Zentner J. Surgical Treatment of Mesiotemporal Lobe Epilepsy: Which Approach is Favorable? Neurosurgery. 2017 Dec 1;81(6):992-1004. doi: 10.1093/neuros/nyx138. — View Citation

Tebo CC, Evins AI, Christos PJ, Kwon J, Schwartz TH. Evolution of cranial epilepsy surgery complication rates: a 32-year systematic review and meta-analysis. J Neurosurg. 2014 Jun;120(6):1415-27. doi: 10.3171/2014.1.JNS131694. Epub 2014 Feb 21. — View Citation

Tellez-Zenteno JF, Dhar R, Wiebe S. Long-term seizure outcomes following epilepsy surgery: a systematic review and meta-analysis. Brain. 2005 May;128(Pt 5):1188-98. doi: 10.1093/brain/awh449. Epub 2005 Mar 9. — View Citation

Wiebe S, Blume WT, Girvin JP, Eliasziw M; Effectiveness and Efficiency of Surgery for Temporal Lobe Epilepsy Study Group. A randomized, controlled trial of surgery for temporal-lobe epilepsy. N Engl J Med. 2001 Aug 2;345(5):311-8. doi: 10.1056/NEJM200108023450501. — View Citation

Wieser HG, Blume WT, Fish D, Goldensohn E, Hufnagel A, King D, Sperling MR, Luders H, Pedley TA; Commission on Neurosurgery of the International League Against Epilepsy (ILAE). ILAE Commission Report. Proposal for a new classification of outcome with respect to epileptic seizures following epilepsy surgery. Epilepsia. 2001 Feb;42(2):282-6. No abstract available. — View Citation

Zhao Y, Ding C, Wang Y, Li Z, Zhou Y, Huang Y. Reliability and validity of a Chinese version of the Quality of Life in Epilepsy Inventory (QOLIE-89). Epilepsy Behav. 2007 Aug;11(1):53-9. doi: 10.1016/j.yebeh.2007.03.013. Epub 2007 May 10. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intelligence assessed by the Wechsler Adult Intelligence Scale	Intelligence is assessed by the Wechsler Adult Intelligence Scale IV (WAIS-IV). WAIS-IV provides four major domains: perceptual reasoning, processing speed, verbal comprehension, working memory. The WAIS-IV also provides two overall summary scores including a Full-Scale IQ and a General Ability Index (GAI), where FSIQ is a measurement of performance across all subcategories, but the GAI is more resistant to issues that might arise from cognitive impairment, allowing for a more precise and truthful analysis. Higher score means better outcome. Intelligence is classified according to the total score : 1) extremely abnormal with more than 130 points; 2) Exceptional: 120-129 points; 3) Higher than usual: 110-119 points; 4) Normal: 90-109 points; 5) Lower than usual: 80-89 points; 6) Boundary: 70-79 points; 7) Mental Retardation: lower than 69 points.	Up to 1 year after epilepsy surgery
Other	Depression assessed by Beck's Depression Inventory	Beck's Depression Inventory (BDI) with 21 items, range of scores, 0 to 63. Higher score means a worse outcome.	Up to 1 year after epilepsy surgery
Other	Anxiety assessed by the State-Trait Anxiety Inventory	The State-Trait Anxiety Inventory (STAI) with 40 items, range of scores, 20 to 80. Higher score means a worse outcome.	Up to 1 year after epilepsy surgery
Primary	Surgery duration	Surgery duration in hours, the time from the beginning of incising the skin to the finish of suturing the skin.	At the end of the surgery.
Primary	Blood loss	Blood loss in millilitres during the operation.	At the end of the surgery.
Primary	Skin incision	Length of skin incision in centimetres	At the end of the surgery.
Primary	Bone flap	Size of bone flap in square centimeter	At the end of the surgery.
Primary	Postoperative hospital stay	Postoperative hospital stay in days, the time from the first postoperative day to discharge date.	Up to 1 month after surgery.
Primary	Complications	The incidence of postoperative complications	Up to 1 year after epilepsy surgery
Secondary	Seizure outcomes classified by the International League Against Epilepsy (ILAE)	Seizure outcomes are classified by the International League Against Epilepsy (ILAE). Specific seizure classifications: class 1, seizure-free; class 2, only auras, no other seizures; class 3, 1-3 seizure days per year with or without auras; class 4, =4 seizure days per year and =50% reduction in baseline numbers of seizure days, with or without auras; class 5, <50% reduction and =100% increase in baseline numbers of seizure days, with or without auras; class 6, >100% increase in baseline numbers of seizure days, with or without auras.; Proportion of each class is calculated.	Up to 1 year after epilepsy surgery
Secondary	Seizure outcomes classified by the Engel	Seizure outcomes are also classified by the Engel classification: class 1, free from disabling seizures; class 2, rare disabling seizures (almost seizure free); class 3, worthwhile improvement; class 4, no worthwhile improvement.; Proportion of each class is calculated.	Up to 1 year after epilepsy surgery
Secondary	Quality of life assessed by the Quality of Life in Epilepsy Inventory- 89	Quality of life is evaluated by the epilepsy- specific Quality of Life in Epilepsy Inventory- 89 (QOLIE- 89). QOLIE-89 is one of the special inventories applied mostly to assess QOL in research protocols, especially in long-term prospective clinical investigations. QOLIE- 89 has 89 items, range of scores, 0 to 100, with higher scores indicating better QOL.	Up to 1 year after epilepsy surgery