NCT04198181Active, not recruiting
The Effectiveness and Safety of Resective Epilepsy Surgery for TRE
Clinical Evaluation of the Effectiveness and Safety of Resective Epilepsy Surgery for Tuberous Sclerosis Complex Related Epilepsy
Source: ClinicalTrials.gov · Last updated 17 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 9 Dec 2019
- Start date
- 12 Dec 2019
- Primary completion date
- 15 Mar 2027
- Lead sponsor
- Beijing Children's Hospital
- Diseases
- Epilepsy
- NCT number
- NCT04198181
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 12 Dec 2019 to the primary completion date, 15 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Abnormal heart, lung, liver, and kidney functions and coagulation function
Other
- Obvious renal angiomyolipoma, pulmonary lymphoma leiomyomatosis, and subventricular giant cell astrocytoma
Who the study is looking for
- 2 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.
Age in the registry: 2 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Children's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.