NCT04198207

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

December 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

5 years

First QC Date

December 9, 2019

Last Update Submit

December 16, 2024

Conditions

Tuberous Sclerosis ComplexEpilepsy

Keywords

tuberous sclerosis complexepilepsyvagus nerve stimulation

Outcome Measures

Primary Outcomes (1)

  • % of patients with Mchugh grading

    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.

    4 years

Secondary Outcomes (2)

  • IQ

    3 years

  • Quality of Life: QOLIE-31

    3 years

Study Arms (2)

VNS Group

VNS group: 20 patients with no localilzed epileptogenic tuber in the brain, and with VNS and multiple anti-seizure medicines.

Control Group

Control group: 50 patients with no localilzed epileptogenic tuber in the brain, and with multiple anti-seizure medicines.

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients from multiple epilepsy centers in China

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Children's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Tuberous SclerosisEpilepsy

Condition Hierarchy (Ancestors)

HamartomaNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryMalformations of Cortical Development, Group IMalformations of Cortical DevelopmentNervous System MalformationsNervous System DiseasesNeurocutaneous SyndromesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornBrain DiseasesCentral Nervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Functional Neurosurgery

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 13, 2019

Study Start

December 10, 2019

Primary Completion

December 10, 2024

Study Completion

December 10, 2024

Last Updated

December 19, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)