Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy (ANT-DBS-RE)

Beijing Pins Medical

Status: Unknown

Conditions: Refractory Epilepsy

Treatments: Procedure: PINS'Deep Brain Stimulator device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02602899

PINS-013

Details and patient eligibility

About

Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation to patients with refractory epilepsy.

Enrollment: 30 estimated patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 12-60.
• having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
• at least 6 seizures per month.
• in good health except epilepsy.
• to with normal MMSE score
• patients or his(her) familys could understand this method and sign the informed consent 7）Patients with good compliance and could complete postoperative follow-up

Exclusion criteria

• results of MRI remind epilepsy caused by intracranial space-occupying lesions.
• the vagus nerve lesion and damage
• tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

PINS Deep Brain Stimulator

Experimental group

Description:

Deep Brain Stimulator is on,continuous stimulation to the brain,

Treatment:

Procedure: PINS'Deep Brain Stimulator device