The Effectiveness and Safety of Vagus Nerve Stimulation for TRE

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Brief Title

The Effectiveness and Safety of Vagus Nerve Stimulation for TRE

Official Title

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

Brief Summary

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

Detailed 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.
    


Study Type

Observational [Patient Registry]


Primary Outcome

% of patients with ILAE grading

Secondary Outcome

 IQ

Condition

Tuberous Sclerosis Complex



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

100

Start Date

December 10, 2019

Completion Date

February 1, 2024

Primary Completion Date

December 1, 2023

Eligibility Criteria

        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
      

Gender

All

Ages

2 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 86-010-59617051, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04198207

Organization ID

TRE-VNS


Responsible Party

Principal Investigator

Study Sponsor

Beijing Children's Hospital

Collaborators

 Beijing Tiantan Hospital

Study Sponsor

, , 


Verification Date

January 2021