Image

The Effectiveness and Safety of Vagus Nerve Stimulation for TRE

Recruiting
2 years of age
Both
Phase N/A

Powered by AI

Overview

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

Description

Control group: no clear epilepsy focus in the brain, and medication has been continued.

Surgery group: no clear epilepsy focus in the brain, and VNS for tuberculosis-related epilepsy.

In order to ensure the follow-up of the study and 3 years after the end of the study, 50 cases were collected in each group of the study.

Eligibility

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

Study details

Tuberous Sclerosis Complex, Epilepsy

NCT04198207

Beijing Children's Hospital

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.