NCT04198207Completed
The Effectiveness and Safety of Vagus Nerve Stimulation for TRE
Clinical Evaluation of the Effectiveness and Safety of Vagus Nerve Stimulation for Tuberous Sclerosis Complex Related Epilepsy
Source: ClinicalTrials.gov · Last updated 19 Dec 2024
Brief summary (registry, in English)
Prospective cohort studies to identify clinical epilepsy control, cognitive changes, and safety of VNS in patients with tuberous sclerosis complex-related epilepsy.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 70 (actual)
- First submitted
- 9 Dec 2019
- Start date
- 10 Dec 2019
- Primary completion date
- 10 Dec 2024
- Lead sponsor
- Beijing Children's Hospital
- Diseases
- Epilepsy
- NCT number
- NCT04198207
What you commit to
- Study type: Observational
- Participants enrolled: 70
- From 10 Dec 2019 to the primary completion date, 10 Dec 2024
- 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
- Surgical Contraindications: Unsuitability for general anesthesia or factors affecting surgical safety.
- Implant Conflict: Presence of implanted medical devices that may interfere with VNS therapy.
Other illness
- Other Severe Diseases: Presence of significant cardiovascular, respiratory, or other systemic diseases.
- Psychiatric Disorders: History or presence of severe psychiatric disorders (e.g., schizophrenia or major depressive disorder).
- Drug Allergy: Known allergy to drugs used in the study.
Other
- Pregnancy or Lactation: Pregnant or breastfeeding individuals.
- Poor Compliance: Inability to adhere to follow-up visits or treatment protocols.
Who the study is looking for
- Age Range: Patients aged 1 to 18 years.
- Confirmed Diagnosis: Diagnosed with Tuberous Sclerosis Complex (TSC) according to established diagnostic criteria.
- Drug-Resistant Epilepsy: Ineffectiveness of at least two antiepileptic drugs (monotherapy or combination therapy).
- Informed Consent: Patients and their guardians understand the purpose of the study and voluntarily sign the informed consent form.
Age in the registry: 1 year to 18 years · 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.