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Temporal Lobe EpilepsyMISET-TLENCT05019404

Minimally Invasive Surgical Epilepsy Trial for Temporal Lobe Epilepsy

A study testing Functional anterior temporal lobectomy (FATL) and Anterior temporal lobectomy (ATL) in people with Temporal Lobe Epilepsy and Open Surgery, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Functional anterior temporal lobectomy (FATL) and Anterior temporal lobectomy (ATL)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
25 Apr 2023to 1 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • male or female aged between 18 and 60 years;
  • drug- resistant temporal lobe epilepsy, remaining seizures after two or more tolerated and appropriately chosen antiepileptic drugs;
  • monthly or more seizures during the preceding year prior to trial;
  • the full- scale intelligence quotient (IQ) more than 70, understanding and completing the trial;
  • signing the informed consent;
  • good compliance, at least 12- month follow- up after surgery.

Who cannot join

  • tumor in temporal lobe;
  • extratemporal epilepsy and temporal plus epilepsy;
  • drug- responsive epilepsy, seizure freedom with current drugs in recent one year;
  • pseudoseizures;
  • seizures arising from bilateral temporal lobes;
  • significant comorbidities including progressive neurological disorders, active psychosis, and drug abuse;
Show all 9Show fewer
  • a full- scale IQ lower than 70, unable to complete tests;
  • previous epilepsy surgery;
  • poor compliance and inadequate follow- up.

Trial locations and contacts

1 site in 1 country.

Yong Liu, MD contact

+8618049529896

liu868yong@163.com

Qiang Meng, MD contact

+8618092586275

mengqiang2019@xjtu.edu.cn

China1 site, 1 recruiting

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Hua Zhang, PhD, 008618909225508, zhanghua@xjtu.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed 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.

Being tested
Functional anterior temporal lobectomy (FATL), Anterior temporal lobectomy (ATL)
Keywords
Temporal lobe epilepsy, Anterior temporal lobectomy, Functional anterior temporal lobectomy, Randomized controlled trial, Minicraniotomy
Medical subject headings
Epilepsy, Temporal Lobe

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional anterior temporal lobectomy (FATL)Procedure or surgery

    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)Procedure or surgery

    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.

Study groups in NCT05019404
Study groupRoleWhat they receive
Functional anterior temporal lobectomy (FATL)ExperimentalFATL via minicraniotomy is a new surgical approach, consisting of amygdalohippocampectomy and the lateral temporal lobotomy.
Receives: Procedure: Functional anterior temporal lobectomy (FATL)
Anterior temporal lobectomy (ATL)Active comparatorATL via large frontotemporal craniotomy is a conventional surgical approach, consisting of amygdalohippocampectomy and en bloc resection of the lateral temporal lobe.
Receives: Procedure: Anterior temporal lobectomy (ATL)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surgery duration

    Surgery duration in hours, the time from the beginning of incising the skin to the finish of suturing the skin.

    Measured: At the end of the surgery.

  2. Blood loss

    Blood loss in millilitres during the operation.

    Measured: At the end of the surgery.

  3. Skin incision

    Length of skin incision in centimetres

    Measured: At the end of the surgery.

  4. Bone flap

    Size of bone flap in square centimeter

    Measured: At the end of the surgery.

  5. Postoperative hospital stay

    Postoperative hospital stay in days, the time from the first postoperative day to discharge date.

    Measured: Up to 1 month after surgery.

  6. Complications

    The incidence of postoperative complications

    Measured: Up to 1 year after epilepsy surgery

Secondary outcomes (3)

  1. 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.

    Measured: Up to 1 year after epilepsy surgery

  2. 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.

    Measured: Up to 1 year after epilepsy surgery

  3. 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.

    Measured: Up to 1 year after epilepsy surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2021
  2. Study start25 Apr 2023 (estimated)
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion1 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
a single-center, prospective, single-blinded, double-arm, randomized, controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05019404
Sponsor's protocol ID
XJTU1AF2021LSK-194
Acronym
MISET-TLE
Status last verified
Nov 2022
First submitted
9 Jul 2021
Last updated
30 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make individual participant data (IPD) available to other researchers.

Publications

  • 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.

    PubMed 22315182

  • 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.

    PubMed 22668889

  • 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.

    PubMed 26926529

  • 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.

    PubMed 11484687

  • 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.

    PubMed 22396514

  • 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.

    PubMed 26017774

  • 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.

    PubMed 12790886

  • 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.

    PubMed 19050193

  • 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.

    PubMed 24559222

  • 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.

    PubMed 11240604

  • 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.

    PubMed 17499025

  • 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.

    PubMed 31627076

  • 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.

    PubMed 28582572

  • 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.

    PubMed 15758038

  • 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.

    PubMed 31288240

Questions about this trial

What is this clinical trial studying?

A study testing Functional anterior temporal lobectomy (FATL) and Anterior temporal lobectomy (ATL) in people with Temporal Lobe Epilepsy and Open Surgery, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yong Liu, MD (+8618049529896, liu868yong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgery duration (time frame: At the end of the surgery.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05019404, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2022.

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