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The Effectiveness and Safety of Resective Epilepsy Surgery for TRE

Study Purpose

Prospective controlled studies to identify clinical epilepsy control, cognitive changes, and safety in resective epilepsy surgery of tuberculosis-related epilepsy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 2 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 2 years old and above, no gender restriction, TSC gene monitoring with or without abnormality.
  • - Diagnosis of nodular sclerosis and 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.
Exclusion Criteria:
  • - Obvious renal angiomyolipoma, pulmonary lymphoma leiomyomatosis, and subventricular giant cell astrocytoma.
  • - Abnormal heart, lung, liver, and kidney functions and coagulation function.
  • - The family did not sign the informed consent.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04198181
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Beijing Children's Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Tuberous Sclerosis Complex, Epilepsy
Additional Details

Control group: clear epilepsy focus in the brain, and medication has been continued. Surgery group: clear epilepsy focus in the brain, and resective epilepsy surgery for tuberculosis-related epilepsy. In order to ensure the follow-up of the study and 3 years after the end of the study, 100 cases were collected from each group of the study.

Contact a Trial Team

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International Sites

Beijing Children's Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Beijing Children's Hospital

Beijing, Beijing, 100045

Site Contact

Shuli Liang, doctor

301_1sjwk@sina.cn

86-010-7051

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