NCT04198181

Brief Summary

A prospective cohort studies to identify clinical seizure control, cognitive changes, and safety in resective epilepsy surgery in patients with TSC-related drug-resistant epilepsy.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Dec 2019Mar 2027

First Submitted

Initial submission to the registry

December 9, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

December 12, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

January 17, 2025

Status Verified

May 1, 2024

Enrollment Period

7.3 years

First QC Date

December 9, 2019

Last Update Submit

January 16, 2025

Conditions

Tuberous Sclerosis ComplexEpilepsy

Keywords

epilepsytuberous sclerosis complexresective epilepsy surgery

Outcome Measures

Primary Outcomes (1)

  • % of patients with ILAE grading

    The grading made by ILAE for the classification of outcome with respect to epileptic seizures following epilepsy surgery. It contains a total of 6 levels. The higher the level, the worse the result. We will count the percentage of patients at each level.

    3 years

Secondary Outcomes (2)

  • IQ

    3 years

  • Quality of Life: QOLIE-31

    3 years

Study Arms (2)

Control Group

Patients in the surgery group will accept exclusive rational medicine therapy.

Surgery Group

Patients in the surgery group will undergo resective surgery combined with rational medicine therapy.

Procedure: Surgery

Interventions

SurgeryPROCEDURE

Resective surgery included lobectomy (partial or total brain lobe resection), tuberectomy (epileptogenic tuber resection), and tuberectomy plus (resection of epileptogenic tuber and perituberal gyri). Tuberectomy was typically performed on the epileptogenic tuber within or near an eloquent area. Lobectomy was performed in patients with large epileptogenic tubers in the brain lobes. Multiple lobectomies, tuberectomies, tuberectomies plus, and lobectomy combined with tuberectomy/tuberectomies plus were further performed in patients with multiple epileptogenic tubers.

Surgery Group

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from participating medical institutions

You may qualify if:

  • years old and above, no gender restriction, TSC gene monitoring with or without abnormality
  • Diagnosis of tuberous sclerosis- related drug-resistant epilepsy
  • Epilepsy course for more than 1 year
  • Patients who have taken 3 or more reasonable choices with appropriate and tolerable antiepileptic drugs (excluding mTOR inhibitors and traditional Chinese medicine and prescriptions) had seizures more than 12 times in the 3 months before enrollment
  • The family members agreed to enroll and signed the informed consent.

You may not qualify if:

  • Obvious renal angiomyolipoma, pulmonary lymphoma leiomyomatosis, and subventricular giant cell astrocytoma
  • Abnormal heart, lung, liver, and kidney functions and coagulation function
  • Preoperative evaluation, it is considered that no surgical treatment is needed
  • The patient received other craniocerebral surgical treatment within 1 year during the follow-up period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Children's Hospital

Beijing, Beijing Municipality, 100045, China

Location

Related Publications (1)

  • Wei Z, Liu T, Cao D, Zhang K, Yang Z, Guo Q, Xu J, Liu S, Liu X, Guan Y, Peng Y, Yuan L, Chen L, Peng J, Han X, Chen C, Chen F, Lin W, Yu T, Zhao X, Wang J, Zhao R, Kuang S, Shi X, Zhai F, Zhang S, Feng W, Shan Y, Ding P, Qian R, Fang F, Chen S, Li H, Wang Y, Liu Q, Zhang H, Li W, Sun M, Zhang R, Liang S. Resective Surgery for Drug-Resistant Epilepsy in Patients With Tuberous Sclerosis Complex: A Prospective Nationwide Multicenter Cohort Study. Neurology. 2025 Nov 11;105(9):e214260. doi: 10.1212/WNL.0000000000214260. Epub 2025 Oct 16.

    PMID: 41100778DERIVED

MeSH Terms

Conditions

Tuberous SclerosisEpilepsy

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

HamartomaNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryMalformations of Cortical Development, Group IMalformations of Cortical DevelopmentNervous System MalformationsNervous System DiseasesNeurocutaneous SyndromesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornBrain DiseasesCentral Nervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Functional Neurosurgery

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 13, 2019

Study Start

December 12, 2019

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 15, 2027

Last Updated

January 17, 2025

Record last verified: 2024-05

Locations

CN(1)