Hippocampal and Thalamic DBS for Bilateral Temporal Lobe Epilepsy

  • STATUS
    Recruiting
  • End date
    Sep 23, 2024
  • participants needed
    80
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 23 January 2021

Summary

The study aims to compare the safety and effectiveness of deep brain stimulation of the hippocampus and the anterior nucleus of the thalamus for reducing the frequency of seizures in patients with bilateral temporal lobe epilepsy.

Description

The outcome of resective surgery for bilateral temporal lobe epilepsy (BTLE) is poor. Neuromodulation such as deep brain stimulation is an alternative therapy for patients with drug-resistant epilepsy, especially for those not suitable for resective surgery. This prospective, randomized, open-label trial aims to compare the effectiveness of deep brain stimulation of the hippocampus and the anterior nucleus of the thalamus for bilateral temporal lobe epilepsy.

Details
Condition Temporal lobe epilepsy
Treatment Deep brain stimulation
Clinical Study IdentifierNCT04164056
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients between 12 to 60 years old
Bilateral temporal lobe epilepsy patients proved by VEEG or SEEG
At least 3 seizures per month but not more than 10 seizures per month, and the longest seizure interval is no more than 30 days during the baseline
Patients failed to at least 3 antiepileptic drugs (AEDs), and are receiving at least 1 AEDs now
Be able to complete seizure diary
Agree to participate this study and sign informed consent

Exclusion Criteria

Extratemporal lobe epilepsy or with potential extratemporal epileptogenic focus
Patients with psychogenic non-epileptic seizures
IQ < 70, or unable to complete the study
Patients are pregnant or plan for it
Patients with implanted electrical stimulation medical device
Patients with other severe neuropsychiatric disorders such as dementia, schizophrenia, or neurodegenerative diseases
Patients with cerebral lesions which unsuitable for lead implantation
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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