Clinical trial · Observational
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
NCT04198207CI-TRIAL-00083941completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective cohort studies to identify clinical epilepsy control, cognitive changes, and safety of VNS in patients with tuberous sclerosis complex-related epilepsy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epilepsy | — | UNRESOLVED | — |
| Tuberous Sclerosis Complex | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- VNS Group
- description
- VNS group: 20 patients with no localilzed epileptogenic tuber in the brain, and with VNS and multiple anti-seizure medicines.
- label
- Control Group
- description
- Control group: 50 patients with no localilzed epileptogenic tuber in the brain, and with multiple anti-seizure medicines.
Primary outcomes (1)
- measure
- % of patients with Mchugh grading
- timeFrame
- 4 years
- description
- The grading made by Mchugh for the classification of outcome with respect to epileptic seizures following epilepsy surgery. It contains a total of 5 levels. The higher the level, the worse the result. We will count the percentage of patients at each level.epileptic seizures following epilepsy surgery. It is used for assessing the control of epilepsy.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria： * 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). * Surgical Contraindications: Unsuitability for general anesthesia or factors affecting surgical safety. * Drug Allergy: Known allergy to drugs used in the study. * Implant Conflict: Presence of implanted medical devices that may interfere with VNS therapy. * Pregnancy or Lactation: Pregnant or breastfeeding individuals. * Poor Compliance: Inability to adhere to follow-up visits or treatment protocols.
References
Publications (0)
Data not yet available
No reference posted for this study.