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Completed

NCT Number: NCT04198207

The Effectiveness and Safety of Vagus Nerve Stimulation for TRE

Prospective cohort studies to identify clinical epilepsy control, cognitive changes, and safety of VNS in patients with tuberous sclerosis complex-related epilepsy.

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Key information

Conditions

Tuberous Sclerosis Complex Brain Diseases Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Epilepsy Genetic Diseases, Inborn Hamartoma Heredodegenerative Disorders, Nervous System Malformations of Cortical Development Malformations of Cortical Development, Group I Neoplasms Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Nervous System Diseases Nervous System Malformations Neurocutaneous Syndromes Neurodegenerative Diseases Tuberous Sclerosis

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Children's Hospital

Beijing, China

About this study

This study aims to evaluate the efficacy and safety of vagus nerve stimulation (VNS) in the treatment of drug-resistant epilepsy in patients with Tuberous Sclerosis Complex (TSC) and compare it with traditional antiepileptic drug therapy. By assessing seizure frequency, severity, and improvements in quality of life, the study seeks to provide evidence-based guidance for clinical treatment strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. % of patients with Mchugh grading

    Time frame: 4 years

    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

  1. IQ

    Time frame: 3 years

    Wechsler Intelligence Scale is used for the evaluation of IQ

  2. Quality of Life: QOLIE-31

    Time frame: 3 years

    QOLIE-31 is suitable for patients 14 years and older. QOLCE-76 is applied to patients aged 2-13 by parents.

Sponsors and collaborators

Lead sponsor

Beijing Children's Hospital

Other

Collaborators

  • Affiliated Hospital of Jining Medical University
  • Army Medical University, China
  • Beijing Tiantan Hospital
  • Capital Institute of Pediatrics, China
  • Capital Medical University
  • Children's Hospital of Fudan University
  • China-Japan Friendship Hospital
  • Chinese PLA General Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • Fourth Medical Center of PLA General Hospital
  • Guangdong 999 Brain Hospital
  • Peking University First Hospital
  • RenJi Hospital
  • Shenzhen Children's Hospital
  • The First Bethune Hospital of Jilin University
  • The Second Hospital of Hebei Medical University
  • West China Hospital
  • Wuhan Medical Care Center for Women and Children
  • Xiamen Humanity Hospital
  • Xiangya Hospital of Central South University
  • Xijing Hospital
  • Xuanwu Hospital, Beijing

Registry information

Official study title

Clinical Evaluation of the Effectiveness and Safety of Vagus Nerve Stimulation for Tuberous Sclerosis Complex Related Epilepsy

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2019
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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